oversight

Administration of Contracts and Grants for Cancer Research

Published by the Government Accountability Office on 1971-03-05.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

REPORT TO THE COMMITTEE
ON LABOR AND PUBLIC WELFARE
UNITED STATES SENATE




Administration Of
Contracts And Grants
For Cancer’ Research           80164031(21




National Institutes of Health
Department of Health, Education,
  and Welfare




BY THE COMPTROLLER GENERAL
OF THE UNITED STATES



                               H 5,1971
                COMPTROLLER         GENELAL      OF-THE      UNlTED        STATES
                                  WASHINGTON       DC     20548




B- 164031(2)




Dear    Mr     Chairman

        This 1s our report           on the admrnlstratlon           of contracts      and
grants    for cancer      research       by the National      Institutes       of Health,
Department        of Health,     Education,       and Welfare          Our review       was
made pursuant         to a request       dated September         25, 1970, from          the
former      Chairman      of the Committee           on Labor     and Public       Wel-
fare,   United    States     Senate,    to assist     and complement          the work
of the Committee’s           Special     Staff on Cancer      Research

         Smce we believe     that the contents         of this report     will be
of interest    to the Congress     and to others         concerned    with can-
cer research,      we have arranged          with the former       Committee
Chairman      to make further     dlstrlbutlon       of the report

                                                       Sincerely           yours,




                                                        Comptroller             General
                                                        of the United           States

 The Honorable         Harrison        A Wllllams,                    Jr
 Chairman,        Committee          on Labor
    and Public      Welfare
 United    States    Senate




             50TH    ANNIVERSARY               1921-      1971
                                               l
                                       .




COMPTROLLER
          GENERAL'S
                  REPORT                           ADMIMISTRATION OF CONTRACTSAND
TO THE COMMITTEE
               ON                                  GRANTSFOR CANCERRESEARCH
LABORANDPUBLICWELFARE                              National Institutes   of Health
UNITEDSTATESSENATE                                 Department of Health, Education, and
                                                   Welfare   B-164031(2)


DIGEST
------

WHYTHEREVIEWWASMADE
       The Chairman of the Senate Committee on Labor and Public Welfare (here-
       Inafter referred to as the Senate Committee) asked the General Account-
       lng Office (GAO) to assist and complement the work of a special staff
       established   by the Senate Committee to study cancer research.

       GAO examined into the admlnlstratlon of the cancer research program
       within the Department of Health, Education, and Welfare (HEW), the Na-
       tional Institutes of Health, and the National Cancer Institute,  lnclud-
       ing the methods and procedures used for processing,  reviewing, and ap-
       proving contracts and grants for cancer research.
       The National Cancer Institute      conducts and supports cancer research
       through (1) research at the National Cancer Institute's       laboratories    and
       cllnlcs,   (2) contracts for research, and (3) grants-In-ald      for research
       proJects      The National Cancer Institute   received an approprlatlon    of
       $181 million    in fiscal year 1970. It awarded 333 research contracts for
       $49 7 million     and 1,782 research grants for $71.4 million

       A committee of consultants  appointed by the Senate Committee to study
       the cancer problem estimated that the program it recommended would re-
       quire annual Federal expenditures for cancer research of $800 mtllton  to
       $1 billion  by 1976


FINDINGSAND CONCLUSIONS
       The present system of administering           and funding National Cancer Instl-
       tute research has resulted in delays           in the approvals and funding of
       contracts and grants.    GAOwas told          by the Director of the National Can-
       cer Institute and some officials    at        research lnstltutlons receiving
       grants that

             --the lnltlatlon     of some research proJects was made uncertain because
                of the lnab-rllty   of some research Institutions to provide private
                funding until final approval and funding was received from the Na-
                tional Cancer Institute    and


Tear Sheet

                                                            MARCH 523-71
                                           1
        --such delays could cause problems for the instltutlons   In attract-
           ing and retain1 ng qualified researchers  (See p. 30 >
Approval       Delags

The 333 contracts awarded during fiscal year 1970 for cancer research
required an average of about 7 months for review and approval.          Approxi-
mately l-l/2    months of that time was the result of what GAO believes
were unnecessary duplicative     reviews by the National Instl tutes of
Health and the National Cancer Institute        (See p 21 ) Specifically,
the reviews of contract proposals by the National Institutes        of Health--
including    the qualifications  of the proposed contractors,   the work
specifications,    and the amounts of the proposed contracts--duplicate
steps in the National Cancer Ins-h tute review       (See p 23 )

Although the Secretary of HEWdelegated contract authority        to the Direr-
tor of the National Institutes    of Health, he did not delegate such au-
thority  to the National Cancer Institute.      GAO believes that much delay
could be eliminated   if the National Cancer Institute program managers
were granted research-contracting    authority.

Research grants during calendar year 1970 required an average of about
8 months for review and approval    A ssgniflcant  portion of thx pro-
cesslng time occurs because the study sectlons which review grant appll
catTons for sclentlfic  merit and the National Advisory Cancer Council
which recommends approval of grant applications   each meet only three
times a year.   (See p. 25 >                                            :
An appllcatlon  submltted after the deadline for review at one of the
three meetings of the applicable   study sectlon would require from 3 to
8 months before it could be consIdered at the next study section meet-
trig.

The National Advisory Cancer Council was establ lshed tn compliance with
the Public Health Service Act      The study sectlons were establlshed      by
the National Institutes of Health to provide an Independent peer review
of the scientific   merit of all applications    to the National Institutes
of Health for research grant funds.      The study sections are made up of
eminent scientists   knowledgeable about research in specific    areas.

In general , all research grant appllcatlons    must go through the same rev
view process, including   a study section evaluation,    and all must receive
Council approval     (See p. 27 ) GAO does not question the meritSh;f      ex-
ternal sclentlflc  reviews of applications   for research grants
present system, however, results in significant     delays.    (See p 28 )

Approximately       45 percent of the 1,182 grants   awarded -rn fiscal   year 19X+$
by the National Cancer Institute were for less than $30,000 each. (See
p. 27 ) To expedite approval of grant appllcatlons  involving moderate
         amounts, GAO belleves          that HEW should consider authorlzlng  program man-
         agers to award grants          up to a specified amount without review by study
         sect3ons

        Fundwq Delays

        Action on the National Cancer Institute  funding request must wait each
        year until the entlre HEW appropnatlon  bill   IS enacted  Cancer research
        proJects, usually from 3 to 5 years in length, are funded annually                          \
        (See p 30 )

         During each of the past 6 fiscal years, the HEWapproprlatlons  were not
         approved by the beginning of the fiscal year in which the funds were to
         be used   Such approval has been delayed from 2 to 8 months.

        Although ongoing research grants and contracts are funded under a Joint
        congressional  resolution  making contlnulng approprlatlons   for a fiscal
        year pending approval of approprlatlons     for that year, the National Can-
        cer Instl tute cannot effectively  plan for research, particularly    new
        programs and proJects, until the National Cancer Institute     appropnatlon
        request IS approved and the total funds appropriated are known

        GAO believes that the Congress should consider authorizing     appropriations
        for the National Cancer Institute    to be available for the next fiscal
        year following   the usual budget year.   This type of advance fundlng has
        been authorized for certain other programs, including    aid to educationally
        deprived children under title    I of the Elementary and Secondary Education
        Act of 1965     (See p. 31 )


RECOMk'ENDAIPIOiW
             OR SUGGESTIONS
        The Secretary of HEW should authorize             the National    Cancer Institute   pro-
        gram managers to

               --negotiate   research    contracts   (see p 24) and

               --award grants up to a specified       dollar   llmlt   without   review by study
                  sections   (See p. 29 )


AGENCY
     ACTIONSAND UNRESOLVED
                        ISSUES
         The Secretary of HEW stated that action was being taken to extend
         research-contracting    authority to the National Cancer Institute       (See
         p 24 ) The Secretary said that HEW planned to evaluate the grant re-
         view system with a view toward strengthening     and expediting   the revlew
         process     He said that the evaluation would include conslderatlon     of
         granting authority   to the National Cancer Institute   program managers to
         award grants up to a speclfled    dollar 11m1t without review by study sec-
         tions     (See p 29 >

Tear
-      Sheet
         --
    The Secretary   stated that,  although funding    delays  are of considerable
    lnconvenlence   and concern to researchers     and research institutions,       at
    the present time the Department did not have any data that lndlcated
    any serious d-csruptl on to research or any s~gnlflcant or widespread
    problems for research lnstltutlons     (See p 31 )

    He stated also that the delays in approprlatlon    approvals could be a
    slgnlflcant  deterrent to lnltlatlon   of the new and sizable cancer pro-
    gram levels vlsuallzed   by the consultants  to the Senate Committee

    The Secretary advlsed GAO that delays in fundIng had emanated most often
    from the recent practice followed by both the Congress and the executive
    branch of establishing  annual spending ceilings      He said that the ef-
    fect of these spending ceilings  on the tjmlng of grant funding was to de-
    lay awards of new grants until a spending plan had been developed for
    the entire fiscal year, which was very difficult    to do until appropria-
    tion and expenditure llmttatlons  were known He said also that the re-
    sult was that typically  HEW did not fund new proJects until well into
    the fiscal year and that this sltuatlon   would exist whether or not the
    grants were advance funded

    GAO recognizes that HEWmust develop an annual spending plan based upon
    various expenditure control llmltatlons;   however, it seems to GAO that
    it would not be desirable to delay financing most new proJects until ap-
    propriation  and expenditure llmltatlons  for the year are known

    GAO belleves that, to optimize the Government's research          investment,
    particularly in view of the adverse effect that delays in          funding can
    have on new research programs and proJects, consideration          should be
    g;ven to the advance-funding mechanism as a means to plan          and program
    research more effectively

   In GAO's opinion, advance funding would enable the National Cancer In-
   stitute   to make awards on the basis of the amount appropriated for the
   year covered by the advance funding and would facilitate    more timely
   financing of new programs and proJects, rather than limit awards for re-
   search to the amounts authorized by a Joint resolution    making continuing
   appropriations,   which generally provides appropriations  up to the prior
   year's level.


MATTERS
      FORCONSIDERATION
                    BY TBE CONGRESS

    The Congress may wish to consider the enactment of leglslatlon     authonz-
          In the case of the Nati onal Cancer Institute,  the making of appro-
    $&ons       to be available  for the next fiscal year following the usual
    budget year     (See p. 34 )




                                       4
                             Contents
                                                                     Page

DIGEST                                                                   1

CHAPTER

       1    INTRODUCTION                                                  5
                Establishment    and functions       of
                  NatIonal    Cancer Institute            r               9

       2    ADMINISTRATION OF CANCER RESEARCHBY THE
            NATIONAL CANCER INSTITUTE                                16
                Utilization       of review committees for
                   decislonmaklng                                    17
                Process used for reviewing            and approv-
                    ing contracts      for cancer research           21
                       Recommendation to the Secretary
                          of Health,     Education,    and
                          Welfare                                    24
                Process used for reviewing            and approv-
                    ing grants for cancer research                   25
                       Recommendation to the Secretary          of
                          Health,   Education,      and Welfare      29
                Delays in funding cancer research
                    program                                              30
                       Matter for consideration         by the
                          Congress                                       34
       3    SCOPE OF REVIEW                                              35
APPENDIX

        I   Letter dated September 25, 1970, from the
               Chairman, Committee on Labor and Public
              Welfare,   United States Senate                            39

   II       Letter dated January 21, 1971, from the
               Secretary,  Department of Health,   Educa-
               tion,  and Welfare,  to the General                   I
               Accounting  Office                                        40

 III        Report of the National Panel of Consultants
              on the Conquest of Cancer                                  44
APPENDIX                                                              Page
  IV       Division    of Research Grants, Natlonal  In-
              statutes   of Health, list  of study sec-
             tlons as of July 1, 1970                                  57

                               ABBREVIATIONS

GAO        General    Accounting     Office

HEW        Department     of Health,       Education,   and Welfare

NC1        National     Cancer Institute

NIH        National     Institutes     of Health
COMPTROLLER
          GENERAL'S
                  REPORT                  ADMINISTRATION
                                                       OF CONTRACTSAND
TO THECOMMITTEE
              ON                          GRANTSFOR CANCERRESEARCH
LABORANDPUBLICWELFARE                     NatIonal Instl tutes of Health
UNITEDSTATESSENATE                        Department of Health,   Education,   and
                                          Welfare B-164031(2)


DIGEST
-em---

WHYTHEREVIEWWASMADE
    The Chalman of the Senate Committee on Labor and Public Welfare (here-
    inafter   referred to as the Senate Committee) asked the General Account-
    lng Office (GAO) to assist and complement the work of a special staff
    established    by the Senate Conunattee to study cancer research,

    GAO examined into the admlnlstratlon of the cancer research    rogram
    wIthin the Department of Health, Education, and Welfare (HEWY the Na-
    tlonal Institutes of Health, and the National Cancer Institut&     lnclud-
    lng the methods and procedures used for processing, reviewing,   and ap-
    proving contracts and grants for cancer research.

    The National Cancer Institute      conducts and supports cancer research
    through (1) research at the National Cancer Institute’s        laboratories and
    cltnlcs,   (2) contracts for research, and (3) grants-in-aid      for research
    proJects.     The National Cancer Institute   received an appropriation    of
    $181 mllllon    ln fiscal year 1970. It awarded 333 research contracts for
    $49.7 million     and 1,182 research grants for $71.4 mllllon.

    A committee of consultants  appointed by the Senate Committee to study
    the cancer problem estimated that the program tt recommended would re-
    quire annual Federal expenditures for cancer research of $800 mtlllon  to
    $1 bllllon  by 1976.


FINDINGSANDCONCLUSIONS
    The present system of admlnlsterang      and funding National Cancer Insti-
    tute research has resulted in delays      ln the approvals and fundlng of
    contracts and grants.    GAOwas told     by the Director of the National Can-
    cer Institute and some offlclals    at   research lnstltutlons recelvlng
    grants that

         --the lnltlatlon    of some research proJects was made uncertain because
            of the inability   of some research lnstltutlons to provide private
            funding until final approval and fundlng was received from the Na-
            tlonal Cancer Institute   and
  --such delays could cause problems for t",e 7nstTtut707s ln attract-
     Ing and retalnlrlg quaIlfled researcherq  See pa 30 )


The 333 contracts awarded during fiscal year 7970 for cancer research
required an average of about 7 months for review dl?CIapproval.         Approxl-
mately l-l/Z    months of that time was the result of what GAO belleves
were unnecessary dupllcatlve     reviews by the National Institutes     of
Health and the National Cancer Institute.       (See p 27 ) Speclflcally,
the reviews of contract proposals by the National Institutes        of Health--
including    the quallflcatlons  of the proposed contractors,   the work
specifications,    and the amounts of the proposed contracts--duplicate
steps In the National Cancer Institute     review    (See p 23.)

Although the Secretary of HEWdelegated contract authority        to the Dlrec-
tor of the National Institutes    of Health, he did not delegate such au-
thority  to the National Cancer Institute.     GAO believes that much delay
could be eliminated   if the NatIonal Cancer Institute    program managers
were granted research-contracting    authority

Research grants during calendar year 1970 required an average of about
8 months for review and approval    A slgnlflcant  portlon of this pro-
cesslng time occurs because the study sections which review grant apple-
catlons for sclentlflc merit and the NatIonal Advisory Cancer Council
which recommends approval of grant appllcat~ons   each meet only three
times a year.   (See p 25 )

An appllcatlon  submitted after the deadline for review at one of the
three meetings of the applicable  study section would require from 3 to
8 months before It could be considered at the next study sectIon meet-
ing.

The National Advisory Cancer Council was established         in compliance with
the Public Health Sermce Act. The study sections were establIshed by
the National Institutes of Health to provide an Independent peer yevlew
of the scientific   merit of all applications     to the National Institutes
of Health for research grant funds.      The  study  sections are made up of
eminent sclenttsts   knowledgeable about research ln specific       areas.

In general , all research grant appllcatlons    must go through the same re-
view process, including a stud section evaluation,       and all must receive
Council approval.    (See p, 27. J GAO does not question the merits of ex-
ternal sclentlfic  reviews of appllcatlons   for research grants.    The
present system, however, results in significant     delays.   (See p. 28 )

Approxtmately   45 percent  of the 1,182 grants awarded tn fiscal year 1970
by the NatIonal Cancer Institute    were for less than $30,000 each. (See
p. 27.)   To expedite   approval of grant appltcatlons ~nvolv~rg moderate
    amounts) GAObe1leves that HEWshould consider authorizing    program man-
    agers to award grants up to a specified amount without review by study
    sections.

    Fundmg Dehys

    Action on the National Cancer Instl tute funding request must wait each
    year until the entire HEW appropriation  bill  1s enacted. Cancer research
    proJects, usually from 3 to 5 years in length, are funded annually
    (See p 30 )
    During each of the past 6 fiscal years, the HEW appropnatlons  were not
    approved by the beginning of the fiscal year ln which the funds were to
    be used   Such approval has been delayed from 2 to 8 months.

    Although ongolng research grants and contracts are funded under a Joint
    congressional resolution   making contlnulng approprlatlons   for a fiscal
    year pending approval of appropriations     for that year, the National Can-
    cer Institute  cannot effectively  plan for research, particularly    new
    programs and proJects , unto 1 the National Cancer Institute   appropriation
    request 1s approved and the total funds appropriated are known.

    GAO believes that the Congress should consider authorizing    appropriations
    for the National Cancer Institute    to be available for the next fiscal
    year follow-ing the usual budget year.    This type of advance funding has
    been authorized for certain other programs, including aid to educatlonally
    deprived children under title    I of the Elementary and Secondary Education
    Act of 1965     (See p. 31.)


RECOMMENDATIONS
              OR SUGGESTIONS

    The Secretary of HEW should authorize           the National    Cancer Institute   pro-
    gram managers to

      --negotiate   research   contracts       (see p. 24) and

      --award grants up to a specified          dollar   llmlt   without   review by study
         sections   (See p. 29 >


AGENCYACTIONS AND UNIESOLVEDISSUES
    The Secretary of HEWstated that action was being taken to extend
    research-contracting      authority  to the National Cancer Institute    (See
    p 24 ) The Secretary said that HEWplanned to evaluate the grant re-
    view system with a view toward strengthening        and expediting the review
    process     He said that the evaluation would include conslderatlon      of
    granting authority      to the National Cancer Institute   program managers to
    award grants up to a specified dollar llnnt without review by study sec-
    tions     (Seep     29)


                                           3
    The Secretary   stated      that,   although   fundIng   delays   are   of    considerable
    lnconvenlence and concern to researchers     and research lnst~tutlons, at
    the present time the Department did not have any data that lndlcated
    any serious dlsruptlon  to research or any s?gn~f~cant or wIdespread
    problems  for research lnstltutions      (See p 31 )

    He stated also that the delays in approprlatlon    approvals could be a
    slgnlflcant  deterrent to lnttiatlon   of the new and sizable cancer pro-
    gram levels vlsuallzed   by the consultants  to the Senate Committee

    The Secretary advised GAO that delays in funding had emanated most often
    from the recent practice followed by both the Congress and the executive
    branch of establlshlng  annual spending celllngs.     He said that the ef-
    fect of these spending celllngs  on the tlmtng of grant funding was to de-
    lay awards of new grants until a spending plan had been developed for
    the entire fiscal year, which was very chfflcult    to do until approprla-
    tion and expenditure llmltatlons  were known. He said also that the re-
    sult was that typically   HEWdid not fund new proJects until well into
    the fiscal year and that this sltuatlon   would exist whether or not the
    grants were advance funded.

    GAO recognizes that HEWmust develop an annual spending plan based upon
    various expenditure control limitations,   however, It seems to GAO that
    It would not be desirable to delay financing most new proJects until ap-
    propriation  and expenditure limitations  for the year are known

    GAO believes that, to optimize the Government's research                     investment,
    particularly tn view of the adverse effect that delays in                      funding can
    have on new research programs and proJects, consideration                     should be
    given to the advance-funding mechanism as a means to plan                     and program
    research more effectively

    In GAO's opinion,        advance funding
                                      would enable the National Cancer In-
    stitute   to make awards on the basis
                                        of the amount appropriated for the
   year covered by the advance fundlng and would facilitate   more timely
   financing of new programs and proJects, rather than limit awards for re-
   search to the amounts authorized by a Joint resolution   making continuing
   approprlatlons, which generally provides appropriations   up to the prior
   year's level


MATTERS
      FORCONSIDERATION
                    BY THECONGRESS
    The Congress may wish to consider the enactment of legislation     authonz-
          II-I the case of the National Cancer Institute, the making of appro-
    ~~~~tlons to be available for the next fiscal year following    the usual
    budget year.     (See p. 34.)




                                            4
                              CHAPTER1

                            INTRODUCTION

        Pursuant to a request dated September 25, 1970, from
the Chairman, Committee on labor and Public Welfare,              United
States Senate, and to subsequent discussions             with the Com-
mittee's     special staff   on cancer research,       the General Ac-
countzng Office has reviewed selected aspects of the admin-
istration     of the cancer program of the National          Cancer In-
stitute     (NC11 of the National      Institutes    of Health (NIH),
Department of Health,       Education,      and Welfare (HEW). Our re-
view was made to assist and complement the work of the Sen-
ate Committeets      dpecial staff     on cancer research.      A copy
of the Chairman's request is Included as appendix I.

       On April 27, 1970, the Senate passed Senate Resolution
376, authorizing    the Senate Committee, with the assistance
of an advisory committee,     to report to the Senate on (1) the
present status of scientific     knowledge with respect to the
causes of cancer and Its treatment,        cure, and elimination,
(2) the prospect of success in such endeavors,         and (3) mea-
sures necessary or desirable     to facilitate    success at the
earliest   possible time.

      Pursuant to this resolution,     a committee of consultants
on the conquest of cancer, composed of 13 eminent laymen and
13 eminent scientists,   was established      in June 1970 as the
advisory committee to assist the Senate CommIttee with the
new study on cancer and was asked to submit its report and
recommendations   at the earliest   practicable    date.

       On July 15, 1970, the House of Representatives        passed
Concurrent     Resolution  675, later passed on August 28, 1970,
by the Senate, expressing       the unanimous sense of the Con-
gress that "the conquest of cancer is a national         crusadtil
and that "the Congress should appropriate         the necessary funds
so that the citizens      of this land and all other lands may be
delivered    from the greatest     medical scourge in history."

      On June 29, 1970, the committee of consultants   held its
first  meeting,   Since that time the committee of consultants
has met 10 full   days, subcommittees have met many additional
days,and the written   or verbal testimony of 289 witnesses

                                    5
and advisors has been considered. On November 25, 1970, the
committee of consultants submitted its report and recommen-
dations to the Chairman of the Senate Committee.
      In the foreword to the report of the committee of con-
sultants, the Chairman of the Senate Committee stated that:
     "After months of intensive and diligent effort,
     this Panel has prepared the attached report, 'A
     National Program for the Conquest of Cancer.'
     The report LS dedicated to the proposition, ex-
     pressed in a recent Concurrent Resolution of the
     Congress, that the conquest of cancer should be
     a national crusade. The recommendations are
     bold and far reaching. They call for a new
     agency, whose sole mission is the conquest of
     cancer. They call for adequate resources of man-
     power, facilities  and funds to do the job in ac-
     cordance with the provlslons of a coordinated
     national program plan."
     The committee of consultants estimated that the program
that it recommendedwould require annual appropriations for
cancer research of $800 million to $1 billion by 1976, A
copy of the report is included as appendix III.
      Cancer is one of the maJor disease problems facing this
nation.   The American Cancer Society estimated that during
1970 about 330 thousand Americans would die from cancer.
Estimated cancer mortality rates by State per 100,000 popu-
lation for 1970 are shown on the map on page 7, and cancer
mortality rates around the world for 1962 and 1963 are shown
on the graph on page 8. The map shows a considerable range
in the incidence of cancer-caused deaths among the several
states.   The graph, which shows cancer mortality rates per
100,000 population in 24 countries in 1962 and 1963, shows
the United States as ranking 18th for males and 19th for
females, Studies are being made concerning the relationship
of the environment to cancer all over the world.
      On December 4, 1970, the Chairman of the Senate Commit-
tee introduced Senate bill 4564 in the Senate, which called
for essentially the action recommendedby the committee of
    \

                              6
i



    J




        7
                                           CANCER AROUND THE WORLD
 AGE-ADJUSTED DEATH RATES FOR SELECTED CANCER SITES IN VARIOUS COUNTRIES, 1962- 63

                                    MALE                                                                     FEMALE

                       0       50   100       150        200                                    0       50     100                        150   200
                                                                                                I        I      I                           I     I
                                                                                    DENMARK                                           1

                                                                                       CHILE        _                                 1

                                                                                     AUSTRIA                                      I

                                                                          GERMANY,        F R                                     1
                                                                                   SCO-fLAND                                      1

                                                                                     BELGIUM                                  1

                                                                                       ISRAEL                                     1
             FRANCE                                                       NETHERLANDS

                                                                          SOUTH       AFRICA                                  I

                                                                       ENGLAND       b WALES                              I

                                                                                     IRELAND        _                     1
   NE”     ZEALAND     k...n                                                         CANADA                           I

                                                                           NEWZEALAND                                 I

NORTH      IRELAND                            1                                       SWEDEN                      I


                                             1                             SWITZERLAND


            CANADA                                                                  FINLAND

                                                                         NORTH      IRELAND


 UNITED      STATES    1-1                                                           FRANCE     I-,


               JAPAN                                                     UNITED       STATES

         AUSTRALIA                                                                   NORWAY

             SWEDEN                                                                    ITALY


            NORWAY                                                               AUSTRALIA

                                                                                       JAPAN


         POd:1::       Fs                         ,          ,


                       0       50    100      150        200
                                                      RATE       PER     100,000      POPULATION
SOURCE       PREPAREDBYGAO
consultants.   On January 25, 1971, a similar   bill         was lntro-
duced as Senate bill   34 in the current Congress.

      In fulfilling  the request of the Senate Commlttee, we
examined into the HEW-NIH-NCI organlzatlonal     structure    and
the methods and procedures used for processing,      revrewing,
and approving contracts    and grants for cancer research.      The
scope of our review 1s described on page 35.

ESTABLISHMENT AND FUNCTIONS
OF NATIONAL CANCER INSTITUTE

      NC1 operates wrthin the framework of the HEW-NIH or-
ganization  and, accordingly,    IS sublect to and must be re-
sponsive to HEW-NIH policies,     procedures,     and requirements.
The chart on page 10 illustrates      the overall    HEW-NIH-NC1 or-
ganlzatlon  as of January 1, 1971.

      In terms of Federal expenditures,         HEW is the largest
Government entity     other than the Department of Defense.            HEW
had 102,500 employees as of June 30, 1970, and in fiscal               year
1970 made estimated       expenditures,  lncludlng    those made from
trust   funds admlnlstered      by the Social Security     Adminlstra-
tion,   of $52.7 bllllon.      HEW is, among other things,       the
Government's prlnclpal       medlcal research organization.

      NC1 was established      In 1937. Part A, Title        IV, of the
Public Health Service Act (42 U.S.C. 281), authorizes             the
Secretary    of HEW, through NCI, to conduct and support re-
search relating     to the cause, diagnosis,       and treatment    of
cancer by directly     performlng     such research in-house and by
awarding grants-in-aid       and contracts    to research lnstltutlons
for performing    research proJects      In the field    of cancer.
The Public Health Service Act also established            a National
Advisory Cancer Council,       which 1s a body of 12 members ap-
pointed by the Secretary       of HEW and three ex officio       Gov-
ernment members, to review and recommend appropriate             action
on applications     for grants-in-aid      and to recommend general
policy and programs.

       During fiscal    year 1970, NC1 employees totaled   about
1,400.     The NC1 admlnlstrative   work force as of September 30,
1970, consisted      of about 260 persons and represented   about 19
percent of the total      1,400 NC1 employees.   The remainder of


                                    9
ORGANiZATlON
           OF SELECTED   OFflCESILF THE DEPARTMENT OF HEALTH,
                 EDUCATKMAklfI Vt'ELFARE
NATIOMALD4STlTUTESDi- tiU,LTH, I\f!D NATlOMALCANCERINSTITUTE
the employees perform principally    research and research
support activities.   This administrative    force does not in-
clude the various NC1 advisory and review committees or NI%
appointed study sections.

        Administrative    services    are also furnished          by NIH to
the NC1 program.        For example, the NIH Research Contracts
Branch is Involved in the negotiation              of NC1 contracts,        and
NIH offices--     such as the associate        directors'      offices  for
Extramural     Research and Training,         Program Planning and Eval-
uation,    Direct Research, Clinical          Care Administration,        and
Administration--provide         administrative       services.

      Presently    NCI conducts,      fosters,    and supports studies
of the occurrence      and distribution        of cancer and laboratory
and clinical    research on the cause, prevent-Ion,                 and methods
of diagnosis    and treatment     of cancer through four major or-
ganizational    components--Extramural          Activities,         Etiology,
Chemotherapy,     and General Laboratories          and Clinics.           Two of
these organizational       components--Etiology          and Chemotherapy--
are referred    to as collaborative         research programs in that
they consist of both in-house and contract                  research,       An as-
sociate director     is in charge of extramural               activities.      The
other three malor organizational            components are each headed
by a scientific     director.

         The Office of the Associate Director           for Extramural      Ac-
tivities     plans and directs    NCI's grant-supported         activities
and recommends NC1 policies        relating    to the administratlon
of grant and contract       programs.      This Office also develops
and coordinates     plans, reviews,       and criteria      for the imple-
mentation     of NC1 grants and research contracts;            evaluates
the effectiveness      of grant-supported       activities;     and advises
NCI's Director,     the National     Advisory Cancer Council,            and
other scientific      advisory bodies of grant and contract               ac-
tivities     and developments.,

      The Office of the Scientific      Director    for Etiology    is
charged with the responsibility      for the major share of NCI's
collaborative     research on cancer causation      and preventlon.
Its investigations      are aimed at finding     means to prevent
human cancers and encompass studies of the cancer risks to
defined human and animal populations.          Investigations    are
also dlrected     toward identifying   viral   and chemical


                                       11
cancer-causmg     agents and the means by which these agents
produce alterations     in living   systems.    The program involves
collaboration    with investigators     in industry,  universities,
and other research institutions       in this country and abroad,

       The Office of the Scientific          Director     for Chemotherapy
plans, directs,       and coordinates      NCI's integrated        cancer
chemotherapy activities,         including     intramural     laboratory     and
clinical     studies,   contracted    research,      and research con-
ducted in cooperation        with other Federal agencies.              The
chemotherapy program is concerned with finding                  the best
methods of treating        cancer through the screening,            testing,
and clinical      evaluation    of drugs.

       The Office of the Scientific        Director    for General Lab-
oratories   and Clinics      has general responsibility         for the
planning and direction        of all In-house laboratory          and clin-
ical studies,    other than the research performed in-house by
the Offices    of Scientific     Director   of Etiology      or Chemother-
apy. General laboratories         and clinics     provide broad re-
search support for the various scientific             disciplines     gen-
erating   knowledge basic to the advancement of cancer re-
search.

       The chart on page 14 shows the NC1 appropriations       from
1960 through 1970. The fiscal      year 1970 appropriation1      by
program for NC1 is shown on the chart on page15,         and the
fiscal   year 1970 estimated  funds obligated  by each of the
four major organizational    components of NC1 and the Office
of the Director,   NCI, are shown below.



'The amount in the chart on page 15 was subsequently           cut
  back by $9.6 millron     to comply with section 410 of the
  Labor-HEW Appropriation     Act for fiscal   year 1970 (Pub. L.
  91-204, March 5, 1970).      The amount appropriated     less the
  cut back plus net transfers     in, totaling   $0.6 million     from
  other NIH appropriations,     equals the $181.3 million      of
  funds obligated.




                                      12
                                       Estimated
                                   obligated funds
                                     for fiscal
                                       year 1970
                                     (millions)

Extramural Activities                  $ 95.3
Collaborative research:
     Etiology                            40.0
     Chemotherapy                        26.1
General Laboratories and Clinics         18.8
Office of the Director                    1.1

        Total                          $181.3
                              NATIONAL CANCER IPaSFlTUTE
                                    APPROPRIATIONS
                                       1960 - 1970



DOLLARS    IN MI1 LIONS
200
      F-




                                                      163 a




110

100

 90

 80

 70

 60

 50

 40

 30

 20

 10

  0
                                                                67         68   69      70
                                          FISCAL   YEAR


                    fLzl
                      ; ’ GRANTS     Q
                                     -
                                         CONTRACTS
                                                      DiRECT
                                                               OTHER DIRECT
                                                               OPERATION
                                                                                OPERATIONS


*$14 6 MILLION FOR CANCER CONTROL HOW APPROPRIATFD        ELSEWHERE
SOURCE     FACT BOOK, NCI, REVISED MARCI-I 1970
                                                      NATIONAL CANCER INSTITUTE
                                                    1970 APPROPRIATION BY PROGRAM
                                                               $190,362,500
                                                                                    $1,573,000
                                                                                     ; REVIEW AND APPROVAL
                                                    $9 601,000                      i
                                                      GENERAL LABS                  I’       $8 517,900
                                                      AND CLINICS ;             I            , ETIOLOGY CHEMICAL AND
                   $27,807,000                                                             ,’ ENVIRONMENTAL    CARCINOGENESIS
                                                                 5:x   ,a
                      CANCER THERAPY        ,,                                           45%
                                              ‘,                           I’             I                    $21,913,500
                                             146%                 i    t                                   ,      ETIOLOGY-VIRUS
 $1,6OO,OOO
    LUNG CANCER                                                                                     115;
                                                                                                     .
                                                                                                                          $2 873 000
$3,130,090                                                                                                                    ETIOLOGY-DEMOGRAPHY
   BREAST CANCER                             A                                                                                AND OTHER
                                                                                                                           -4
$1,608,000                                                                                                         15%r
   ALL OTHER DIRECT                                                                                        &@
   ACTIVITIES                                                                                                                      $1.466.000
                                                                                                           w--       8%---.           i310rinETRY EPIDEMIOLOGY
                                                                                                           L                          AND FIELD STUDIES
                                                                                                             --.
 $16,315,000                                                                                                          48% Lo $9 178.000
    FELLOWSHIPS     ---8    6%-                                                                                            --
                                                                                                                               REIMBURSEMENT   TO
    AND TRAINING                                                                                                    -- 6%      MANAGEMENT    FUND

                                                                                                                      1%             $1-036 000
                                                                                                                           \            PROGRAM     DIRECTION
                                                                                                                               \
                                                                                                                                    ‘\
                                                                                                                                   $250,000
                                                                                                                                       RESEARCH DEVELOPMENT
                           .ABLE                                                                                                       AND RADIATION    THERAPY




         $76 657 000
            UNPROGRAMMED
            RESEARCH PROJECTS                         TOTAL   RESEARCH GRANTS                                                      SUPPORT GRANTS
SOURCE     FACT BOOK,      NCI, REVISED   MARCH 1970           $83,495,000
                              CHAPTER2

               ADMINISTRATION
                            OF CANCERRESEARCH
               BY THE NATIONALCANCERINSTITUTE
     The present system of administering  NC1 research and
the method of funding the research has resulted   in signifi-
cant delays in approving and funding contracts   and grants
for cancer research.

       NIH awarded 333 cancer research contracts,   totaling
$49.7 million,    during fiscal year 1970.   These contracts    re-
quired an average of about 7 months for review and approval.
About 1% months of this review and approval time was the
result    of what we believe were unnecessary duplicative    re-
views by NIH and NCI,

        During calendar year 1970 the revrew and approval pro-
cess for appllcatlons      for research grants required  an average
of about 8 months.      This processing  time was due, to a large
extent,     to the fact that both the study sections which must
review grant applications      and the National Advisory Cancer
Council which must approve grant applicatrons       met only three
times annually for recommending grant approvals.

       During each of the past 6 fiscal      years, the HEW appro-
priatlons    were not approved by the beginning of the fiscal
year in which the funds were to be used.           The delays of such
approvals,    which ranged from 2 to 8 months, hlndered effec-
tive planning for research,    p articularly     for new programs
and projects.

        We were told by the Director,       NCI, and by some grantee
offlclals     at research lnstltutlons      that, because of the in-
ability    of some research institutions         to provide interim
private    funding until  final     approval and funding 1s received
from NCI, the lnltlatlon       of some research projects       was made
uncertain.




                                   16
UTILIZATION OF REVIEW COMMITTEES
FOR DECISIONMAKING

        There are 25 committees or groups, with approximately
279 members, which advise and assrst NC1 in the management
of the cancer program.       NIH has 47 study sections,      with
about 700 persons who are primarily        nonfederally    employed
persons, which review the research grant applications             of all
institutes,    lncludlng   NCI, for scientific    merit within     the
broad fields     of medicine and public health.        Each grant ap-
plication,    however, is reviewed by only one study section.

      The National Advisory Cancer Council was established        in
compliance with the Public Health Service Act.        The various
study sections were established   by NIH to provide an inde-
pendent peer review of the sclentlflc     merit of all appllca-
tlons to NIH for research grant funds.       The study sections
are made up of eminent scientists     knowledgeable   about re-
search in specific  areas.

       The chart on page 18 illustrates             the review and advisory
groups which have responsibilities              for cancer programs.        The
study sections,        depending on the specific          research area in-
volved,    review NC1 research grant applications.                 Also, three
committees review NC1 research grant applications,                    three
committees review NC1 training-grant               appllcatlons,      15 com-
mittees advise or assist in the management of NC1 collabora-
tive research,       including    contract    research,      two committees
advise on NC1 laboratory          and clinical      research,     and two
groups (the Natronal         Advisory Cancer Council and the Sclen-
tlflc   Directorate)       advise on the overall        program.

       The review and advisory groups' members are selected
primarily    from outside the Government and represent         leading
medical or sclentlflc      authorities      in the study, diagnosis,
or treatment     of cancer and in specialized       areas of health-
related   research,   fundamental      sciences,  or medical sciences.
Several of the committees have NIH or NC1 employees repre-
sented on the committees,       and a few committees are com-
prised entirely     of NIH or NC1 employees.

      The chart on page 20 illustrates      the organizational     and
administrative  arrangements within HEW, including         the advl-
sory and review groups, relating      to the etiology    program.

                           I

                                       17
                                                                           NATIONAL CANCER INSTITUTE
                                                           REVIEW AND ADVISORY COMMITTEES AND FISCAL YEAR 1970
                                                                      OBLIGATIONS BY PROGRAM AREA



         47 STUDY SECTIONS          FOR REVIEW OF                                                 i
         RESEARCH     GRANTS        OF NCI AND OTHER                                                  3 COMMITTEES       REVIEW   APPLICATIONS
         NIH INSTITUTES                                                                               AND ASSIST IN MANAGEMENT           OF CERTAIN
                                                                                                      MULTI-DISCIPLINARY        GRANT    PROGRAMS
         STUDY SECTIONS        ARE    BASED   ON VARIOUS
         DISCIPLINES                                                                                  TOTAL    OF 52 MEMBERS
         EACH SECTION       HAS AN AVERAGE        OF
         15 MEMBERS




                                                                                RESEARCH                                                   RECOMMENDATIONS        TO
                                                                               $81 0 MILLION                                               DIRECTOR,      NIH, ON ALL
                                                                                                                                           GRANT     APPLICATIONS
 GRANT      APPLICATIONS
                                                                                                                                           RECOMMENDS    ON MATTERS
                                                                                                                                           RELATING   TO NC1 PRO
                                                                                                                                           GRAMS AND ACTIVITIES

                                                  $14 4 MILLION                                                                            TOTAL      OF 12 MEMBERS
                                                                                                                      ICE   OF   THE




                                                                                                                                                   MAKES REVIEWS     AND
                                                                                                                                                   RECOMMENDATIONS       ON NC
                                                                                                                                                   PLANNING,   POLICY    AND
                                                                                                                                                   PERSONNEL




                                                                                                      SCIENTIFIC    CONTENT       AND

                                         5 COMMITTEES      TO ADVISE   AND/OR   ASSIST
                                         IN MANAGEMENT       OF SPECIFIC    PROGRAMS

                                         TOTAL    OF 43 MEMBERS
SOURCE      PREPARED       BY GAO                                                          I
        The Sclentlfrc     Director    for Etiology     receives   advice
directly    from four committees and indirectly             from two com-
mittees.      In addition     to receiving    direction     from the Set-
retary of HEW through normal channels,              the Director,    NCI,
receives policy direction           or program advice from several
staff organizations        within HEW-NIH. Both the Deputy Assls-
tant Secretary,        Research and Development, HEW, and the As-                a
sociate Director        for Direct Research, NIH, have policy and
program guidance responslbllitles            for the etrology      program.

       In the area of contracting,           a number of internal        and
external      groups are involved.         The Assistant     Secretary,
Comptroller,       HEW, and the Assistant         Secretary    for Admlnlstra-
tron, HEW, establish          overall   financial    and admrnistrative
policy     for contracting.        The  Research    Contracts     Branch under
the Associate        Director   for Adminlstratlon,        NIX, performs ad-
ministrative       review and negotiation         of contracts.      Scien-
tific    review of etiology        research contracts       1s the responsi-
bility     of eight contract       review committees made up of NC1
and NIH employees and non-Government consultants.




                                      19
               ORGANIZATIONALAND ADMINISTRATIVEARRANGEOENTS
             ON THE NATIONAL CANCERINSTITUTE'SETIOLOGYPROGRAM
STAFF
   .="NcTIOHS                              LINE FUNCTIONS
PROCESSUSED FOR REVIEWING AND
AJ?PROVINGCONTRACTSFOR CANCER RESEARCH

       In recent years NC1 has made extensive use of research
contracts    in Its collaborative    research programs.   Of 1ts
$181 million    of fiscal   year 1970 obligations,   NC1 awarded
333 research contracts      for $49.7 million.

        The 333 contracts    required   an average of about 7 months
for review and approval.         Approximately   l-l/Z months of that
time was the result       of what we believe were unnecessary du-
plicative    reviews by NPH and NCI.
       The contractor       selection    and proposal review process
commences with an NCI scientist's             proposal to establish    a
specific    project      under contract     support and ends upon award
of a contract.         Contract    proposals   are reviewed by the ap-
propriate     scientific      review committee.      The review covers
the scientific       aspects of the proposal and the propriety           of
the selection       of the contractor.        Each review committee is
responsible      for the review of contract         proposals relating
to a given type or phase of scientific              research.

       The process of contract    development and award can be
divided into two phases:       the development of a project and
the preaward procedures     leading up to the award of a con-
tract.

        The program scientific       director,     a program scientific
coordinator     (project   officer     or project     orlgrnator),     and an
NC1 program contract       specialist      determine that a proposed
project    is relevant   to their      established     program.      Then a
recommendation      is developed on the source of potential              con-
tractors     and on the scope of the work to be solicited.                 Ap-
proval of the scientific         director      for the program area is
then obtained to proceed with the contract                 selection   and
proposal review process.

      The schedule on page 22 shows that it takes an average
of about 7 months of processing        time from advertising     to
the award of a contract        when the contractor selection     in-
volves multiple    solicitation     of prospective contractors.
The processing   time is broken down by steps, and the number
of days required    for each step and the cumulative         days at
each step are shown.

                                      21
      After advertrsJng    and obtalnrng    the proposals,   the NC1
proJect officer    and contract  specrallst    make a pxllmlnary
screening of all proposals to eliminate        those which are not
responsive   to the requirements    of the project    or which are
otherwise   unacceptable.


                       Schedule of ProcesslngTlme      for NC1
                   Research Con&acts   from Inltlatron    to Award

          Days    cumu-
          per    lative
   Step   step     days                                     Procedure

     1    30       30      Advertlsrna      the effort--1nrtratron      of a research con-
                           tract    normally consists of advertlslng          the scope and
                           obJectIves     of the proposed prolect       and requesting
                           Interested     contractors      to submit resumes of their
                           qualrflcatlons       rather than proposals      for the effort.
                           Thus period rncludes the time when the Grants and
                           Research Contracts         Operatrons Branch receives word
                           from the speclfx         program offrcrals    to advertise
                           through the time when the program offrcrals             advise
                           the Contracts       Operations     Branch on which of the re-
                            sumes received merrt request for proposals.

     2     21      51      Obtalnlnc      pronosals     and forwardlnp         them to nropram
                           offlclals.

     3     34      85      Contractor     selectron      (when multrple   solicitation         1s
                           Involved)--Prellmrnary          screenrng by prolect        officer
                           and contract      specrallst.       Evaluation  by an ad hoc
                           group of the proposals received on a proJect and
                           its recommendatron        of one of these proposals.

     4     28     113      Review of proposal         by program        offlcrals.

     5     14     127      Preparatxon   of revleT' committee "pac'~aae", by the
                           Contracts   Operation   Branch--Delrvered  1 week prior
                           to committee meetrng

     6     14     141      Contract review corn&tee  review--Allows                     1 week to
                           revxew "packages" and 1 week to prepare                     mrnutes.

     7     14     155      Preparation   of flnal   review commrttee                 "package"   by
                           the Contracts   OneratIon    Branch

     8     18     173      Review by final         review     committee.

     9      4     177     -oval          by NC1 Director

                          PrPparats         of propram memo to NIH.

    10    47      224     /Negotratlon      of contract        by NIH.

                                             of contract           Work begins.




                                              22
       The In-depth review by the program officials        (step 4
on pe 22) involves both the scientific        and the admlnlstra-
tive aspects of the proposal,       such as the capabilIty     of the
contractor,    the type of contract    proposed, the proposed
budget of the contractor,    and a check for scientific        dupli-
cation of effort.

       The method of reviewing        prospective    contracts    for can-
cer research had its inception           in the early days of the che-
motherapy program, which was initiated            in 1955. At that
time it was believed that a review system similar               to the
study section-National        Advisory Cancer Council concept used
m reviewing     grants was needed.         Chemotherapy panels (com-
posed of outside consultants)          and the Chemotherapy Review
Board (composed of the chairmen of the panels plus some
members of the National        Advisory Cancer Council) were es-
tablished.     As time went on, however, difficulty            was expe-
rienced in recruiting        outside consultants      with no appearance
of conflicts    of interest.        As a result,    a system was estab-
lished in which preaward reviews were made first               by standing
program committees comprised of NC1 staff             and then by the
 Scientific  Directorate.

      Subsequently,   early in 1965 Congress gave considera-
tion to adding to the HEW appropriation       bill  a requirement
that the National    Advisory Cancer Council review each con-
tract before award.      As a compromise, it was agreed that
NC1 periodically    would provide the National     Advisory Cancer
Council with information     regarding  the plans for and status
of the contractual    program.    This procedure is still     being
used,

        After the Director,      NCI, approves the contract        propos-
als,    the  Research  Contracts     Branch  In   the  Office  of  the
Associate Dlrector      for Administration,        NIH, negotiates      and
finalizes     the contracts.      The Secretary,      HEW, has formally
delegated contracting        authority    to the Director,     NIH, who
in turn has delegated this authorrty            to certain    NIH offl-
cials but not to any NC1 officials.

       Contract negotiations     by NIH take approximately
l-1/2 months and duplicate        several of the review steps pre-
viously   taken by NCI.      Specifically,       the reviews of contract
proposals    by the NIH contracting        officers--including   the

                                     23
quallficatlons      of the proposed contractors, the work spec-
lficatlons,   and the amounts of the proposed contracts--
duplrcate   certain    work m steps 3, 4, and 6 of the NC1 re-
view 1.n the schedule shown on page 22.

Conclusion

       We believe that about l-1/2 months of the -/-month pe-
riod required    to review and approve an NC1 research contract
consisted   of an unnecessary duplication     of review by NIH
and NCI. We believe also that much of the l-1/2 months
could be eliminated     if NIH gave research-contracting   author-
ity to NC1 program managers.

Recommendation   to the Secretary     of HEW

        Accordingly,   we recommend that the Secretary   of HEW
authorize     NC1 program managers to negotiate  research con-
tracts.



        In his comments dated January 21, 1971 (see app. II),
on a draft of this report,     the Secretary    of HEW stated that
action was being taken to extend research-contracting         au-
thority    to NCI.  The Secretary noted that HEW studies had
recommended decentralization      of research-contracting    author-
ity to NC1 and other NIH components which have a large vol-
ume of research contracts.




                                 24
     PROCESSUSED FOR REVIEWING AND
     APPROVING GRANTS FOR CANCER RESEARCH

           In fiscal year 1970 NCI awarded 1,182 research grants
     amounting to $71.4 million.   The research grant review and
     approval process, which is summarized rn the chart on
     page 26, took an average of about 8 months during calendar
     year 1970.

           A significant      portion of this processing     time occurs
     because the study sections that review grant applications
     and the National Advisory Cancer Council that recommends
     approval of grant applications        each meet only three times
     a year.    All applications,     regardless  of amounts involved
     or complexity,      are held for some period of time, the amount
     of time depending upon when the applicable          study sections
     and the National       Advisory Cancer Council will meet.

             Inherent   in such a review process is a certain     amount
     of time when most applications        are Just waiting   for the next
     step without     being processed.     For example, as indicated
     below, an application       for a new project   submitted between
     February 2 and the June 1 deadline for submission of an ap-
     plication     would take from 3 to 8 months to reach the study
     section review.       It would then have a 6- to lo-week wait be-
.,   fore consideration       by the National Advisory Cancer Council.

           The National Advisory Cancer Council meets three times
     annually to consider grant applications.       The frequency of
     its meetings determines,   to a great extent,     the timing of
     the grant review process.    The following    table  illustrates
     key dates in the grant review process for fiscal         year 1969
     Council meetings.
     Deadline for sub-
       mission of appli-
       cation to NIH:
          Renewal                &Y 1           Sept.   1     Jan.   1
          New and supple-
            mental               June1          Oct. 1        Feb. 1
     Period of study sec-        Aug. 28 to     Jan, 5 to     Apr. 12 to
       tions meetings              Sept. 29       Feb. 1        %Y 3
     Period of National
       Advisory Cancer           Nov. 18 to     Mar. 10 to    June 16 to
       Council meetings            Nov. 20        Mar. 12       June18

                                      25
    f



                    In reply to a GAO suggestion        in a draft of this report
             that meetings of study sections          and the National   Advisory
             Cancer Council be scheduled more frequently,           the Secretary
*            of HEW stated that there was a serious danger that an in-
             crease in the frequency of these meetings would jeopardize
             the ability    of NIH to obtain the kind of expert advice
             needed to ensure the quality         of its programs.     He said that
             the eminent scientists       involved would be most reluctant        to
             commit significant     additional     time away from their    schools
             and laboratories     and that,     in any case, the time saved by
             addltlonal    meetings would be minimal.        (See app. II.>

                   In general,   all research grant applications,      regardless
             of the complexity    of the project  or the amount of funds re-
             quested, must go through the same review process and there-
             fore require   approximately   the same overall   processing    time.

                     In fiscal  year 1970 NC1 awarded 1,182 research grants
             totaling     about $71.4 million,  Grants of under $30,000 each
             made up 45 percent of the number of grants and about 12 per-
             cent of the dollar      amount.

                 Amount of                   Percent of              Percent of
             individual   grant            total   number          total   amount
                    award                of grants awarded       of grants awarded

             $         0 to $ 9,999              13                          1
                 10,000 to 19,999                13                          3
                 20,000 to 29,999                19
                                                 -                           !z
                    Total                        45                         12
             In excess of $30,000

                    Total

                    The review process for grant applications             starts with
        .i   the Division     of Research Grants of NIH, which is the central
        1
        h    receiving    point   -for - all grant applications.        The Dlvlsion
              - _
        *    designates,     on the basis of program relevance,           the institute
             to which applications          are referred  and assigns the appllca-
             tions for scientific         review to one of the study sections
             which are organized along scientific            discipline     lines.
             (See app. IV.)


                                                 27
      IO ensure scientific      excellence    rn the revrew of grant
proposals,  NIH and NC1 use study sectlons made up of such
experts as sclentlsts,       educators,   and others in the scien-
tfflc  area of the research covered by the grant application
being consrdered       The responsrbillty       of the study sectlons
and the special review committees reviewing            NC1 grant pro-
posals includes determining        the sclentrflc     merit of the pro-
posed research.     Prrorrties     are established     by these groups
on the basis of scientific       merit.

       The grant appllcatlons     relevant    to cancer, along with
the study sections evaluations,         are forwarded to the Na-
tional Advisory Cancer Council.          About 400 to 500 applica-
tions are considered at each meeting.            The National Advisory
Cancer Council usually has approved the study sections'            rec-
ommendatrons without       any material    change.   The proposals
recommended by the National Advisory Cancer Council with the
highest priorltles      are funded within     the lrmitations   of
available   appropriations.

        All applications      to be funded are sent to NCI's busi-
ness staff,     which reviews the funding level In the appllca-
tlon for reasonableness          of the amounts involved.     c0unc11
recommendations are used as a guideline.            The remaining ap-
plications     are grouped into two categories,        those which may
be funded later       If sufficient    money is available    and those
not to be funded.        During fiscal    year 1970 the chance of not
obtaining    funds for newly approved projects         for cancer re-
search was about 50 percent.

Conclusion

      We do not question the concept or the merits of scien-
tific  reviews by outside committees in approving research
proposals     for the purpose of setting     priorities   on the basis
of scientific     merit.   However, the fact that the system of
review and approval of proposals for research projects            has
reached the point at which proposals for NC1 grants take an
average of about 8 months to process raises the question of
whether the present system should be continued.            We believe
that, unless some measures are taken to streamline           and ex-
pedite the review and approval process,          the problem of de-
lays In the review and approval process probably would be
made worse if the substantial       increases in the amount of


                                  28
cancer research     recommended by the committee   of consultants
are appropriated      by the Congress.

Recommendation     to the Secretary    of HEW

       Accordingly,   we recommend that the Secretary of HEW
authorize    the NCI program managers to award grants up to a
specified    dollar limit without  review by study sections but
with the review and recommendations      of the National  Advisory
Cancer Council.



       In commenting on this matter,     the Secretary   of HEW in-
formed us that the Department planned to review all aspects
of the grant review system with a view toward strengthening
and expediting    the review process.      He also stated that the
Department's    evaluation   of the grant review system would
include consideration      of granting  authority  to NC1 program
managers to award grants up to a specified        dollar  limit
without   review by study sections.      (See app. II.)




                                  29
DELAYS IN FUNDING CANCER RESEARCHPROGRAM

        Because the NC1 budget 1s part of the HEW budget, ac-
tion on NC1 funding requests must wart until            the entrre HEW
appropriation     bill   1s enacted.    Cancer  research    projects,
usually    from 3 to 5 years in length,       are funded annually.
Although ongoing research grants and contracts             are funded
under a Joint congressronal        resolution   making continuing
appropriations      for a fiscal   year pending approval of appro-
priations     for that year, NC1 cannot effectrvely         plan for re-
search, particularly       new programs and projects,       until    the
NC1 approprlatlon      request is approved and the total          funds
approprrated     are known.

      The Director,      NCI, and some grantee officials        advised
us that, because of the lnablllty           of some research rnstrtu-
tlons to provide Interim        private    funding until  final    approval
and funding 1s received from NCI, the initration             of some re-
search proJects was made uncertain.             Also, the Drrector,
NCI, and the grantee officials          informed us that such delays
could cause problems for research lnstrtutlons            In attractrng
and retaining    qualified    researchers.

Effect of HEW budget process
on fundrng cancer research

        Each of the 10 institutes     at NIH has separate approprr-
ations,    and each must be considered during the budget pro-
cess by various levels wlthrn HEW and the Executive Office
of the President,      as well as by the approprratlon    committees
of Congress.      For example, In fiscal    year 1970 HEW had a
total    of 88 approprlatlon    requests to prepare and justify.
Conslderatlon    of the HEW approprratlon     request takes sub-
stantial    time each year, as shown below by the dates of en-
actment for the past 6 years.
                                               Budget delay
                                Date of        from June 30
           Fiscal year         enactment          (months)
                1966              8-31-65
                1967            ll- 7-66
                1968            ll- 8-67
                1969            10-11-68
                1970              3- 5-70
                1971              l-11-71

                                     30
        Although NC1 has a separate appropriation,    the NC1          bud-
 get is consolidated     with the NIH budget and included in           the
 overall    HEW budget, so that the NC1 budget must compete            with
 all other HEW research and health,     education,  and welfare
 programs.     The budgetary process takes 24 months and is            pre-
 sented in the chart on page 32.

        Many scientific   researchers    depend primarily   upon NC1
  for research funds,     Research experiments     talce several years
  to perform;   therefore  grants generally    are awarded for pe-
  riods ranging from 3 to 5 years, subject to annual fundmg.
  About a year prior to the expiration       of the grant award, the
  researcher   must begin the application     process anew to fi-
  nance a new experiment     or series of experiments     or a contin-
  uation of the prior experiment      that was not completed within
  the estimated    time,, Officials   of some research institutions
  informed us that they were unable to fund new projects          for
' periods of time because of delays in Federal appropriations.

  HEW's comments and our evaluation

        We believe that, to minimize the effect             of the substan-
  tial   time delays in obtaining     appropriations        and funding for
  NC1 grants and contracts      each year, the possibility          of adopt-
  ing the practice    of authorizing      advance funding should be
  considered by the Congress.        This can be accomplished through
  authorizing    and malting appropriations      to be available       for
  the next fiscal    year following     the usual budget year.           This
  type of advance funding was authorized           by title     I of the
  Elementary and Secondary Education Act of 1965, as amended,
  for the program of aid to educationally           deprived children
  and by the Economic Opportunity        Amendments of 1969,

          The Secretary     of HEW advised us that, at the present
  time, despite delays in the funding of new grants and con-
  tracts,    HEW did not have any data that indicated          any serious
  disruption    to research under the funding mechanism and that
  HEW was not aware of any significant         or widespread problems
  encountered by research institutions          in attracting    qualified
  staff.     He stated that funding delays were a considerable
  inconvenience     and concern to the research institutions           and
  to individual      investigators,    not only U-I the cancer program
  but also throughout        the programs admlnistered      by HEW. The
  Secretary    concluded that the delays in appropriation

                                       31
                                   NATIONAL CANCER INSTITUTE
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    approvals   could be a significant  deterrent                to initiation      of
    the new and sizable cancer program levels                  visualized      by the
    consultants   to the Senate Committee.

           Also, the Secretary     of HEW advised us that delays in
    funding had emanated most often from the recent practice
    followed by both the Congress and the executive            branch of
    establishing     annual spending ceilings.        For example, in re-
    gard to the fiscal      year 1970 appropriations,      funds were
    withheld     from HEW by the Office of Management and Budget to
    keep 1970 Federal outlays within       the overall     budget estl-
    mate for the year, and funds were also withheld            as a re-
    sult of limitations      placed by the Congress on the expendl-
    ture of appropriations.

           The Secretary     stated that the effect     of these spending
    ceilings    on the timing of grant funding was to delay awards
    of new grants until       a spending plan had been developed for
    the entire    fiscal   year, which was very difficult       to do until
    appropriation     and expenditure     limitations   were known. He
    also said that the result        was that typically    HEW did not
    fund new projects      until   well into the fiscal    year and that
    this situation      would exist whether or not the grants were
    advance funded.

           We recognize    that HEW must develop an annual spending
    plan based upon various expenditure                control    limitations;
    however, it seems to us that it would not be desirable                        to
    delay financing     most new projects          until     appropriation       and
    expenditure   limitations       for the year are known. We believe
    that it would be desirable           to begin financing          new projects
    as soon as possible       after    the beginning         of each fiscal       year
    wIthin the authority        of either      a joint      congressional      resolu-
    tion making continuing         appropriations         for the fiscal       year
    which generally     limits appropriations           to the prior years
    level,   or advance funding.           In either      case provision       could
I   be made to hold back a reasonable amount of funds to cover
    any estimated    expenditure       limitations        that might be imposed
    subsequently.

          We believe that, to optimize the Government's        invest-
    ment in terms of both facllltres     and the sclentlflc      knowl-
    edge accumulated by professional     researchers,   particularly
    in view of the adverse effect    which delays in funding can

                                            33
have on the lmplementatlon      of new research programs and proJ-
ects, conslderatron     should be given to the advance-fundlng
mechanism as a means to plan and program research more effec-
tively.    In our opinion,    advance fundlng would enable NC1 to
make awards on the basis of the amount appropriated       for the
year covered by the advance fundlng and would facllltate
more timely planning and flnanclng       of new programs and proJ-
ects, rather than llmlt     awards for research to the amounts
authorized   by a Joint resolution    making contlnulng  approprla-
tions

Matter   for   conslderatlon   by the Congress.

       In consrderatlon  of the foregoing   observations   concern-
ing the problems of funding cancer research,       the Congress
may wish to consider the enactment of leglslatlon        authorlz-
ix,    in the case of NCI, the making of approprlatlons       to be
available    for the next fiscal year following    the usual bud-
get year.




                                  34
                              CHAPTER3

                          SCOPE OF REVIEW

      Our review was directed      toward obtarnlng      rnformatlon
concerning   the organlzatronal      and adminrstratlve      problems
associated  with implementing      a large-scale,     mission-oriented
program to conquer cancer wlthrn the present structure               of
NIH, as expressed to us In a letter         dated September 25,
1970, from the Chairman of the Senate Commrttee on Labor and
Public Welfare.    Our review also was concerned with the use
of grants and contracts      rn financing    cancer research,

        Our review was accomplished through dlscusslons        with
offrclals     of NIH, NCI, and various grantee institutions         and
through the use of available        records and documents relating
to the administration      of research contracts    and grants,     the
organization     and administration     of HEW-NIH-NCI, and the HEW
budget process.




                                 35
APPENDIXES




37
                                                                       APPENDIX I




                                      September     25, 1970


Honorable Elmer B. Staats
Comptroller  General of the United   States
General Accountltlg Office
441 G Street       -
Washington, D.C. 20548

Dear General   Staats
           Pursuant to Senate Resolution    376 (copy enclosed), a Special
Staff of the Senate CommIttee on Labor and Public Welfare 1s conducting
a study of our current efforts    In cancer research to deterrmne the best
way to Implement a maJor national    effort  to conquer cancer.

             The problems associated mth lmplementlng a large scale,
mission-oriented      program mthm the present structure     of the National
Institutes     of Health must be examined m considerable     detail.    It 1s
my understanding      that your staff has been resident m NIH for a
considerable     period of tune and therefore  has background and experience
that can be very helpful to the Special Senate Staff          I further
understand that our staffs have dLscussed the problem and agree
that your people should be able to contribute       m an important way to
this effort.

             It 1s therefore    requested that the General Accounting Office
provide such assistance      as you consder appropriate      to the Special
Staff on Cancer of the Senate Comzzttee on Labor and Public Welfare
in developing background and support for Its report on implementing         a
maJor effort      on cancer.  It would be patilcularly    helpful  if
prelunlnary     lnformatlon  could be made avallable   before the end of
October 1970 with a final report submItted by the end of the year.

           Please be assured   of w personal      appreciation   for any asszstance
you may give in this matter.




mclosure
RWY/mmb




                                     39
APPENDIXIL
    Page 1
                       THE   SECRETARY       Or    riEALTH       EDUCATION       AN”   WELFARE
                                           WAZHINGTON            D   C   20201




                                                                             JAN 21 1971

 Mr.    Dean K. Crowther
 Assistant      Director
 Umted     States     General  Accounting               Office
 W ashmgton,         D. C. 20548

 Dear    Mr.     Crowther:

 Thank     you for the opportumty                 to comment             on the draft   report     of the
 Comptroller      General’s    Review               of Selected          Aspects    of Admlmstratlon
 of Cancer     Research.

  This draft      report    examines       the organlzatlonal          structure          of the
 Department         of Health,      Education,       and Welfare        (HEW),          the National
 Institutes      of Health     (NIH),     and the National         Cancer      Institute       (NCI)
 relatmg       to the adrmmstratlon            of the cancer       research        program,           and
 the method        and procedures          used for processmgJ,            revlewlng          and
 approvmg        grants     and contracts        for cancer      research;        and considers
 alternative       approaches        to such methods         and procedures.                The basic
 alrn of the report         appears      to be the ldentlflcatlon           of problems           of
 orgamzatlon         and processes         that rmght      mnhlblt    or deter        the proper
 adrnmlstratlon          of a cancer      research      program       of a much larger               size
 or that recommended              by the Commlttee           of Consultants            appolnted       by
 the Committee           on Labor      and Public      Welfare.

 The report’s       fmdmg       1s that slgnlhcant            delays      In approving        and funding
grants     and contracts        for cancer          research       are caused        by long delays
In Congressional           approval       of HEW fiscal           year budgets         and by problems
in the Internal        review     and approval           procedures.            Because     of the delays
 “the lnltlatlon      of some       research         proJects     was uncertain..          . and that GAO
was told that the delays              can cause problems                to research       mstltutlons
m attrackng         and retamlng          quaIlfled       researchers.”            We assume          that
the delays       In funding     of grants         and contracts          as noted by the GAO,
applies     to new programs             and appllcatlons           smce all on-gomg             grants
and contracts        are funded         under      a contlnulng        resolution      pendmg       approval
of appropriations.




                                                   40
                                                              APPENDIXII
                                                                     Page   2

Page 2 - Mr.    Dean K. Crowther

At the present time, despite delays U-Lthe fundmg of new grants and
contracts we have no data that mdlcate any serious dlsruptlon              to re-
search conducted under these mechanisms             nor are we aware of any
slgnlflcant   or wldespread      problems encountered by research lnstltu-
tlons 1~1attractmg     quallfled staff.    We are, of course, aware that
fundmg delays of new grants and contracts are a considerable
mconvenlence      and concern to the research mstltutlons         and lndlvldual
inves tzgators, not only in the Cancer program,          but throughout the
programs     admlnlstered      by this Department      Every effort has and will
continue to be made to m’mlwL1ze the mconvenlence            and problems
involved.    However,     the delay in approprlatlon     approvals could be a
slgnlflcant   deterrent to mltlatlon     of the new and sizable Cancer
program levels vlsualleed         by the Consultants to the Committee

In our view, the funding delays m the awards of grants and contracts
are caused prlmarlly      by events outside the control of this Department,
 such as the lag m approval of annual budgets as mentloned m the
 report.     The delays caused by Office of the Secretary-Office          of the
Director,     National Institutes    of Health-Natlonal    Cancer Institute
internal    review and approval procedures          are mmlmal.   As outlmed
further In this letter, the speed-up of the processes involved may do
damage to the sclentrflc       review necessary to fund only research
proJects of high sclentlhc        merit without achlevmg slgnlficant      time
 s avlngs .

The followmg    are the Department’s    comments on the recommendations
cited m the report.    For convenience,    the response to each 1s listed
directly  below the recommendation,      as follows:

       1.   Provide for more frequent meetings of NIH study sections
       and the National Cancer Advisory Council to mmlmlze   approval
       delays.

       There IS a serious danger that an increase m the frequency
       of NIH study section and council meetings would Jeopardize
       the ablllty of the NIH to obtain the kind of expert advice
       needed to assure the quality of Its programs.       The eminent
       sclentlsts    mvolved would be most reluctant to commit
       slgmflcant     addltlonal time away from their schools and
       laboratorxes.       In any case, the time saved by addltlonal
       meetings would be mmlmal.



                                     41
APPENDIXII
    Page 3
Page   3 - Mr.        Dean    K      Crowther

       2      Grant     authority  to NCI program                managers      to award
       grants    up to a speclfled     dollar  limit             without  review    by
       study    sections.

       We ~111 include         conslderatlon        of this idea m our future
       evaluations       of the proJect      grant     review   system.      We are
       planning      to review     all aspects      of this system      with a view               toward
       strengthening        it In a number        of areas,    mcludmg      expedltmg
       the process.

       3.     Grant      authority       to NC1 program          managers         to negotiate
       contracts,

       Studies     conducted   by my office       have recommended              decentrall-
       zatlon    of research     contracting      authority      to NC1 and other
       NIH components         which    have a large       volume      of research
       contracts        Steps are being      taken to effect        this recommendation.

       4      Congress     consider      leglslatlon          authorlzmg,          In the case
       of NCI,     the makmg        of approprlatlons             for the     fiscal   year next
       followmg      the usual budget        year.

        We doubt that this recommendation                        goes to the true source              of
        the problem.            We believe      that delays         m funding        have emanated
       most      often from        the recent      practice       followed        by both the
        Congress         and the Executive          Branch       of establlshmg           annual
        spending        cellmgs        The effect       of these       celhngs       on the tlmmg
       of grant       fundmg      1s to delay new awards                until a spendmg          plan
       has been developed              for the exre          fiscal     year.       Thus 1s very
       dlfflcult      to do until final       approprlatlons            are known.         The result
       has been that typlcally             we do not fund new proJects                   until well
       into the fiscal          year      Ths    sltuatlon       would       exist whether        or not
       the grants         were forward        funded.

       We believe        that as we gam experience      with the execution          of
       expenditure         control  devices we can overcome         the Impact      on
       the tlmmg        of grant   awards.   On the other     hand,    there    IS not
       much that       we can do to speed-up      the approprlatlon        process.




                                                  42
                                                                                   APPENDIXII
                                                                                       Page 4
Page   4 - Mr.     Dean     K.   Crowther

       in summary8           the real problem        lies xn the fact that approprla-
       tlon actlon      has been occurrmg           later  and later    with each fiscal
       year.      This,     coupled   wxth the requirements          for expenditure
       controls,      has occasioned         the problem     wzth which     both the
       Department         and your    report     are concerned.

We trust    that these      comments        will    be helpful      in your   reporting   to the
Commzttee       Chairman.

                                                        Smcerely,




                                                        Secretary




                                                   43
APPENDIXIII
     Page 1



        Dlst   Congress                  CONXITTEE               PRINT
          2a   SESSION




                     NATIONAL PROGRAM FOR THE
                         CONQUEST OF CANCER

                                             REPORT
                                                    OF THE


           NATIONAL PANEL OF CONSULTANTS ON
                 THE CONQUEST OF CANCER
                                              AUTHORIZED          BY


                                              S Res 376
                            (Agreed to by Senate April 27, 1970)
                                            PREPARED       FOR    THE


                           COMMITTEE ON LABOR AND
                               PUBLIC WELFARE
                            UNITED STATES SENATE




                                           NOVEMBER               1970

                                                    PART     1



                         Printed    for the use of the Committee          on Labor and
                                              Pubhc Welfare


                                   U S GOVERNMENT          PRINTING      OFFICE
         5!2-532                           WASHINGTON             1970




                                                     44
                                                                                            APPENDIXIII
                                                                                                 Page 2




                 COMMITTEE           ON    LABOR     AND          PUBLIC    WELFARE
                       RALPH      YARBOROUGH             Texas,   Chawman
JENNINGS      RANDOLPH          West VlrSlnis            JACOB K JAVITS,     New York
HARRISON       A WILLIAMS,        JR , New Jersey        WINSTON    L PROUTY,      Vermont
CLAIBORNE       PELL,   Rhode Island                     PETER   H DOMINICK,      Colorado
EDWARD       M KENNEDY,          Massachusetts           GEORGE    MURPHY,     Cahfomis
GAYLORD       NELSON,    Wisconsin                       RICHARD    S SCHWEIKE      R, Penm) lvanfa
WALTER     E MONDALE,         M.mnes~ta                  WILLIAM  B SAKBE,     Ohlo
THOMAS     li EAGLETON,          Mmoun
ALAN    CRANSTON,      Calffornm
HAROLD       E HUGHES,       Iowa
ADLAI    E STEVENSON         III, Ihnois
                                  ROBERT 0 HARRIS, St@ Dmctor
                                 GENE E GODLEY, &nerd     Counsel
                             ROY H =LENSON,    Mtnonly  Staf Dzrector
                               EUQENE MIPFELMAN. Mtnorztg Counsel




                                                    45
APPENDIXIII
     Page 3




                COMMITTEE      OF CONSULTANTS         ON CANCER
                       (Appended   Pursuant   to S Res 376)
                           BENNO C SCHMIDT, Chawman
                         Dr SIDNEYFARBER, Cochaarman
     I W ABLL                          Dr HENRYS KAPLAN
     WILLIAM McC BLAIR, Jl             I)r MATHILDI- KRIM
     ELMER BOBST                       MI-~ M41ty WI LLS LAWRENCE
     Dr JOSEPH BURCHFNAL               Dr JOSHU I LFDLRBLRG
     Dr R LEF CLARK                    EMIL MU~Y
     Dr PAUL B CORNFLY                 MICHAI LJ O'NEILL
     EMERSON FOOTE                     JUR~L R PARTFN
      G KEITH FUNSTON                  LAURANCI b ROCK~FILLER
     Dr SOLOMON GARB                   I)1 JONATHAN E RHOADS
      Mrs ANNAROSENRERGHOFFMAN         Dr HYROID P RUSCH
     Dr JAMESF HOLLAND                 1)~ WCNDILL G ~COIT
     Dr WILLIAM B HUTCHINSON           LPI\ W\SSl RMQN
                            STAFF OF TBC COMMITTEE
                             Robert F Sweek, Dwector
                         Carl M Flxlnan, Deputy Dwector
                       Mrs Helena Cur&, Speczal Assastant
                        John A Grnnes, Edatord Darector




                                              46
                                                                      APPENDIXIII
                                                                           Page 4




                               Foreword

                                                  US      SENATE,
                  COMMITTEE    ON I&lOR       AND PURLI    WELFARE,
                                                     November 27, 1970
    Cancer 1s a disease which can be conquered Our advances m the field
of cancer research have brought us to the verge of important           and
excltmg developments m the early detection and control of this dlead
disease; but as a nation we have not put forth the effort necessary to
exploit the full potential of these gams, nor have we made the proper
effort to ascertain what addltlonal avenues of research should be
opened
    In March of this year, I mtroduced a resolution supported by 53 of
my colleagues m the Senate, calling for a completely new study of can-
cer, cancer research, and the cause and cure of cancer The Intent of tins
resolution IS to make the conquest of cancer a natlonal goal of the hlgh-
est pnorlty
    The resolution authormed the Comrmttee on Labor and Public Wel-
fare to study cancer research activities It specifically charged the com-
mittee to “examme, mvestlgate, and make a complete study of anv and
all matters pertammg to (1) the present status and extent of sclentlfic
research conducted by governmental and nongovernmental          agencies to
ascertain the causes and develop means for the treatment, cme and
elnmnatlon of cancer, (2) the prospect for success m such endeavors,
and (3) means and measures necessary or desirable to facllltate success
m such endeavors at the earliest possible time ”
     As a result of this resolution a Panel of Consultants on the Conquest
of Cancer, composed of 13 emment laymen and 13 emment sclentlsts,
was established to assist the Comrmttee with the new study on cancer
After months of mtenslve and dIllgent effort, this Panel has plepared
the attached report, (‘A Natlonal Program for the Conquest of Cancer ”
The report 1s dedicated to the proposltlon, expressed m a recent Con-
current Resolution of the Congress, that the conquest of cancel shonld
be a national crusade The recommendations are bold and far reaching
Thev call for a new agency, whose sale IIusslon 1s the conquest of can-
cer They call for adequate resources of manpower, facllltles and funds
to do the Job m accordance w&h the provlslons of a coordmated na-
tlonal program       lan The recommendations, along with the supportmg
 findings, are spef led out 111detail m the attached report
     I mtend to introduce m this session of Congress major leg&atlon to
nnplement these recommendations          and I therefore commend this re-
port to the committee and to the Senate for early conslderatlon
                          a          RALPH W YARROROUQR, C'hazmmn
                                    tv




                                         44
APPENDIXIII
     Page 5




                              Letter of Transmittal

                                       NEW YORK, N Y , November .%5,1870
       Hon RALPH W YARBOROUGH,
       Ch%rm,un, Comzttee on Labor and Publtc Welfare,
       US Senate, Wadmgton,         D C
          DEAR Mi CHAIRMAN I am pleased to present heremth the report
       and recommendations      of the Comnuttee of Consultants on Cancer
       appomted pursuant to Senate Resolution 376 Part I of the report sets
       forth m 12 brief paragraphs a summary of the cancer problem, the
       areas of special promise which offer unusual opportumtles for mtensl-
       fied effort, and the recommendations of the comrmttee Part II of the
       report sets forth the sclentlfic and medical background m more detail
       For the convenience of your committee, this part of the report IS also
       preceded by a summary of the sclentlfic material
          Of the $250,000 appropriated by the Senate for this study, you will
      be pleased to learn that we have comnntted or spent only approx-
      lmately $75,000 This has been possible because of the generous con-
      tllbutlon    of time and effort of many persons who would not have
       been available at all on a rennbursement basis, but who, because of
      their dedlcatlon to the goals of this study, have given most gen-
       erously of their time and talents These included not only members of
      the committee, but several hundred members of the sclenttic com-
      mumty whose lives are devoted m a large measure to work related
      to the conquest of cancer
          I would hke to express my personal appreclatlon to the members
      of the comrmttee, not only for their splendid cooperation and 100-
      percent dedlcatlon to our task, but more particularly     for the unprec-
      edented hours of work which they have devoted wlthout reservation
      The sclentlfic and professional members of the committee have borne
      by far the largest burden of the work of our CommnXee, and no group
      could have given more unselfishly of their time and talent The com-
      mittee 1s most appreclatlve to the members of the sclentlfic commumty,
      mcludmg those at the National Cancer Institute, and to the members
      of our staff for the mformatlon,      views, and suggestions which they
      have so generously made available to the committee
          The committee was most fortunate m the diverse views and back-
      grounds represented, and m such a group one would not expect nor
      did we have unanimous agreement on all POIJ&, However, there has
      been unammous commitment to the obJectlve of the study as set forth
      m the Senate resolution Out of our dlscusslons and differences we
      have been able to crystalhze a consensus TIM report represents that
      consensus
          The committee 1s unammously        of the view th&, the conquest of
      cancer 1s a reallstlc goal If an effective national program along the
      lines recommended m the report IS promptly mltlated and relentlessly
      pursued
               Respectfully,
                                             BENNO C SCHMIDT, CWmrnmn
                                          (VII)




                                          48
                                                                   APPENDIXIII
                                                                        Page 6




  ANATl[O~AkPROGRAMFORTWECON&UEST
               OF CANCER
                             INTPODUCTION

   On April 27,19’70, the Senate passed Senate Resolution 376 author-
1Zln~ the Senate CommnXee on Label and Pubhc Welfare, with the as-
s&&e       of an advisory committee, to rep01 t to the Senate on (1) the
present status of sclentlfic knowledge with respect to the causes of
cancer and its treatment, cure, and ellmmatlon,       (2) the prospect of
success m such endeavors, and (3) measures necessary or desirable to
facilitate success at the earliest possible time Pursuant to that resolu-
tlon, the Committee of Consultants was designated m June 1970, and
was asked to subrmt its report and recommendations          at the earllest
practicable date
    On July 15, 1970, the House of Representatives passed Concurrent
Resolution 675, later passed by the Senate, expressmg the unanimous
sense of the Congress that “the conquest of cancer IS a national cru
sade” and that “the Congress should appropriate the necessary funds
so that the cltlzens of this land and all other lands may be delivered
from the greatest medical scourge m history ”
    On June 29, 1970, the Committee of Consultants held Its first meet-
ing Smee that tune the Committee has met 10 full days, subcommittees
have met many addltlonal days and the wrrtten or verbal testnnony
of 289 rmtnesses and advlsors has been consldered The Committee 1s
 pleased to present herewith its report and recommendatmns
                   SUNMARY    AND RECOMMENDATIONS

    1 Cancer IS the No 1 health concern of the American people A
poll conducted m 1966 showed that 62 percent of the public feared
cancer more than any other disease Of the 200 ml&on Americans alive
today, 50 mllllon ~111 develop cancer at present rates of mcldence, and
34 m&on wdl die of this pamful and o&n ugly disease, If better
methods of prevention and treatment are not discovered About one-
half of cancer deaths occur before the age of 65, and cancer causes more
deaths among children under age 15 than any other disease Over 16
percent of all deaths m the United States are caused by cancer, makmg
it by a wide margin our second greatest killer (after cardiovascular
diseases) Cancer often St&es as harshly at human dignity as at
human hfe, and more often than not it represents financial catastrophe
 for the farmly m whch It strikes
    2 The amount spent on cancer research IS grossly madequate today
For every man, woman, and child m the United States, we spent m
 1969 $410 on national defense, $125 on the war m Vietnam, $19 on
the space program, $19 on foreign aid and only $0 89 on cancer re-
 search Cancer deaths last year were 8 times the number of lives lost
 m 6 years m Vietnam, 51/z times the number k&d m automobile accl-
                                   (1)




                                      49
APPENDIXIII
     Page 7
                                            2
        dents, and gleater than the number of Americans lL~lled m battle m all
        4 J cals of Wolld War II Given the sel~ousne~s 01 the cancer problem
        to the health and morale of our society, this allocation of national
        pllolltles seems open to serious question In addltlon to the poignancy
        of the disease, and the death and suffering that it causes, the econonuc
        loss is staggering, with estimates of its costs to the Nation rmnmg as
        Hugh as $15 bllllon pel year, of which some $3 to $5 bllhon represents
        direct care and treatment costs and the balance 1sloss of earnmg power
        and productlvlty
           3 The mcldence of cancer 1sIncreasing This IS partly due to the fact
       that a greater number of our cltlzens are reachmg more advanced
        ages, where cancer strikes more frequent1 , but It 1s also due to the
       sharp increase m lung cancer, undoubte B ly attributable         to the air
        pollution m certain environments and most Importantly          to the self-
        pollution of those who smoke cigarettes It IS estimated that if the
         4mencan people stopped smoking cigarettes this alone would ehml-
        nate about 15 percent of all cancer deaths
           4 The nature of cancer IS not yet fully known We know that human
        cancers are caused by certain chemicals, by certain types of radiation,
        and probably by viruses The precise mechanisms by which these car-
       cmogenlc agents cause, or mtelact to cause, cancer 1s not known, and
        1 el y little 1s known about the natural defense mechamsms that prevent
        cancer m some cases and not m others A great deal more must be
        learned about chemical carcinogens, radiation, and viruses, and how
        they work We must also learn more about what takes place at the
       cellular level when cancer occurs There 1s very strong suggestive e\ I-
        dence that viruses cause some human cancers, but which viruses, how
       they are transmitted, and how they operate are unknown It 1s errone-
        ous to thmk of cancer as a smgle disease with a single cause that will be
       sublect to a single form of m-ununlzatlon (as m the case of poho) or a
       single cm e Cancer comprises many diseases and results from a vallety
        of caUses that R 111have to be dealt with m a variety of ways However,
       as our knonledge IS expanded, more and more cancers ml11 become
        prel entable or curable
           5 The cure rate for cancer IS gradually lmprovmg In 1930 we were
        able to cure only about one case In five, today we cule one case m
        three, and it 1s estmlated that the cure rate could be brought close to
       one m two by a better appllcatlon of knowledge which exists today,
        1 e detectlon at an earlier stage through the more widespread use of
       exlstmg techniques (such as the Papamcolaou test for women and
       mammography) , coupled with an extension to all cltlzens of the same
        quality of dlagnosls and treatment now available at the best treatment
       centers There are three methods for curmg cancer today surgery,
        ladlatlon therapy, and chemothera         Often two or even three of these
       methods are used m combmatttlon firome types of cancer are far more
       curable than others For example, early breast cancer treated by sur-
       gery, cancel of the cervix by radlatlon or surgery, and chonocarcl-
       noma and Rurkltt’s tumor by chemotherapy, are among those most
       susceptible to cure today Treatment techmques are lmprovmg mark-
       edlv, particularly     m radlatlon therapy and chemotherapy, and more
       widespread avallabll$        of the best quality detection and treatment
        will give us more and mole cures However, it 1s still true that those
       cancers which dlssemmate lapidly are seldom curable today, and this
       represents a major gap m our exrstmg knowledge Where we stand
       today m our knowledge of the causes, nature, prevention, dlagno=s,
                                                                          APPENDIXIII
                                                                               Page 8
                                        3
treatment,   and control of cancer IS set forth m detail m part II of this
repo1t
    6 There Ease been malor advances m the fundamental               hnonl~lpc
of cancer m the past decade, and these advances m knon ledge lid\ e
opened up far more promlsmg areas for mtenslve mvestlgatlon than
ha\c ever heretofore exlsted These areas of special promise must be
explored with tlgor, if we are to exploit the great opportunltles            that
lie before us They are examined m detail m part II of this report
    Among the areas of special promise which must be aggressllel?
pursued are
           (a) The ldentlficatlon      and stud) of the chemxal, phvslcal, and
       other environmental      factors that cause cancel (food additives, am
       pollutants, Industrial hazards, radmtlon, and other carcinogens) ,
           (b ) Viruses causing cancer (what viruses cause cancer, how are
       thev transmitted, and how do they act) ,
           (P) CM1 and turn01 biology (mcludmg cell surface phenomena,
       molecular functions, dlfferentlattlon and genlc expression, controls
      of cell dlvlslon, mechanisms of metastasis, nutritional           require-
       ments and other biological factors) ,
           (d) Immunologv        (host resistance agamst cancer, its nature,
       causes and therapeutic use) ,
           (e) Epldemlology       (the variables III cancer mcldence and types
       stemmmg from geographic. social, economic, nutrltlonal,          occupa-
       tional, and constltutlonal differences)
           (f) Cancer prevention (more effective utilization         of existmg
       knowledge and mtenslfied research on preventive measures) ,
           (g) Dlagnosls (the development of new and Improved dlag-
       nostic techniques) ,
            (h) Chemotherapy        (the development of new and better drugs
       and Improvement m their uses) ,
           (2) RadIotherapy       (development of new and better techniques
        and apparatus for radiation therapy) ,
            (1) Surgery (the best techniques m cancer surgerv coupled with
       earlier diagnosis must be made generally avaIlable 111 order to
       further increase the cure of cancer Better rehabdltatlon             tech-
       niques must be further developed and utlllzed to return the cancer
        patient to an active and full life) ,
            (h) Combmatlons        of treatment modahtles     (Improvement      m
       treatment results bv better comblnatlons of surgery, radiotherapy,
       chemotherapy,       and nnmunotherapy)
    ‘7 A natlonal program for the conquest of cancer 1s now essential
 If we are to exploit effectively the great opportunltles        which are pre-
 sented as a result of recent advances m our knowledge However, such
 a program will require three malor mgredlents that are not present
 today
           First, effective admmlstratlon       with clearly defined authoxltv
        and responslblllty ,
           Second, the development of a comprehensive national plan for
        a coherent and systematic attack on the vastly complex problems
        of cancer Such a plan would mclude not only programmatic               re-
        search where that 1s appropriate, but also major segments of much
        more loosely coordmated research where plans camlot be define-
        tively laid out nor long-range obJectives clearly spectied , and
           Third, the necessary financial resources
APPENDIX      III
           Page 9
                                                     4
                   11 t 4c present time there 1s no cooldmated national program or
              ljrcl_;r km plan The Xatlonal Cancer Instltute has done excellent work
              l&elf and has supported grants and contracts m the scientific com-
              mullIt     whlrh hare resulted m much outstandmg work, but the over-
              all research eftort IS frdgmented and, for the most part, unccordmated
              The effort m cancer should now be ex anded and mtenstied under an
              effectlre admmlstratlon        charged wit % developmg and executmg a
              comprehensive nataonal plan for the conquest of cancer at the earllest
              possible time The three foregoing elements are considered separately
              m more detail 111the succeeding paragraphs 8,9, and 10
                 8 Admtnzstrafwn       -An effective major assault on can< el 1eqmres an
              admmlstratlr e setup which can efficlentlg admmlstel the coherent
             program that 1s reqmred m this formidable and complex sccrentlfic
              field Such a setup Q 111not be easy to achieve wlthm the Federal Gob -
              ernment The effecter e nnplementatlon          of such a program will reqmre
              a slmpllficatlon     of orgamzatlonal    arrangements and a drastic reduc-
              tlon m the nunlbel of people mvolved m admmlstratlve              decisions This
              tape of straight-lme      organlzatlonal    efficlpncy does not exist today m
              the National Cancel Institute, the Nattlonal Institutes of Health, or
              the Department of Health, Education, and Welfare Obxqously, flom
              man\ standpoints It can be argued that any cancer program should
              be m the Department         of Health, Education, and Welfnxe and indeed
              that It should be m the National Institutes of Health Honever, there
              IS real doubt whether the kind of organlzattlon that IS rymred                 for
              this program can m fact be achieved wlthm the Nallonal Institutes
              of Health OI wlthm the Department of Health, Education, and Wel-
              falc ,4part from the question of whether It can be done, there 1s also
              the questlon of whether it would be wise to reqmre the Secretary of
              Health, Education, and Welfare to attempt to give cancer the prlonty
             necessary to carry out the congressional mandate m a department
              charged with the multiple health and other responabllltles                of that
              Department
                 in the past Then the Federal Government has desired to give top
              pllorltg to a malor scientific prolect of the magmtude of that mvolved
              m the conquest of cancer, It has on occasion, w&h conslderable success,
              gl\en the responslblllty for the proJect to an independent agency Such
              an agencv provides a degtee of independence m management, plan-
              nmg, budget presentation, and assessment of progress which IS d&cult
             if not lmposslble to achieve m a large government department                   Ac-
              cordmgly, if the Congress and the admmlstratlon            are truly committed
              to making the conquest of cancer a “national crusade”, as expressed in
             the conrurrent resolution of the Congress It IS the view of the Com-
             mlttee that a X’atlonal Cancer Authorlty            should be estabhshed whose
              mlsslon 15 defined by statute to be the conquest of cancer at the earllest
             possible time A.11 the functions, personnel, faclhtles, appropnatlons,
              programs, and authoxltles of the National Cancer Institute should be
             tlansfrrred      to the Natlonal Cancer Authority         The Authollty     should
             be headed by an ,4dmmlstrator           appomted by the President with the
              adI ice and consent of the Senate, and he should report directly to the
             President and present 111sbudgets and programs to the Con ress In
             considering the feaslbllltt of an independent agency, x5 should f >eborne
             m mmd that we are talking about a major sclentlfic program and, as
             pomted out m subsequent paragr a phs, not the delivery of patrpnt cnle
             generall, m cancer cases The only patlent care mvolvcd m tins plo-
             gram will be that associated w1t11 clmxal research and trachxg and
             the development and demonstlatlon            of improved methods III fhe d+




                                                     52
                                                                       APPENDIXIII
                                                                           Page 10
                                      5

h\ery of patlen t care undertaken              as a part of the comprehenslve
1)’ ograni plan
    The powers of such a National Cancer Authority              should be very
broadly defined m order to accomplish a mlsslon of this complexity
It would not be useful to attempt to enumerate here all the powers
that such an Authority           should have and m the wrltmg of the unple-
mentmg leglslatlon, the Committee belleves that the powers should be
broadly defined and not enumerated                 However, the followmg     are
lllustratlve of the kmds of powers which the Natlonal Cancer Author-
lty will have to be able to exercise m order to carry out a comprehen-
sive program of the type envisaged
            (a) The power to enter mto prnne contracts with authority m
        the prime contractor to enter mto subcontracts,
            (6) The power to commit avallable funds until expended rather
        than on a year-to-year basis,
            (c) The power to authorize exceptions to exlstmg regulations,
        whele necessary, to permit the use of expernnental drugs, blo-
        loglcals, and devices m cancer research,
            (d) The power to establish or support the large-scale productlon
        of speclallzed blologcal        materials for cancer research, such as
        viruses, cell cultures, ammals, and the hke, as well as the power
        to set standards of safety and care for those using such materials,
            (e) The ower to support research outslde the United States by
        highly qua Ytied foreign nationals, collaborative research mvolv-
        mg Amencan and foreign participants, and trammg of Amencan
        sclentlsts abroad and foreign sclentlsts m the Umted States, to
        the extent that such actlvltles ml1 promote the accomphshment of
        the mrsslon The Committee believes that cancer research offers a
        particularly    fruitful field for collaboration with other nations, m-
        cludmg those nations with whom present cooperation IS lmnted
         but with whom greater collaboration 1sdesired ,
             ( f) T%e power to fund by loan, grant, contract, or otherwise any
         facllltles or programs, or to take such other actions, as may be
         required for the accomplishment of the nusslon
     9 Progrurn p2an. -A compreheneve national plan for the conquest
 of cancer should be developed as promptly as possible The develop-
 ment of a coherent overall program plan should mclude the followmg
 features
      (a) The present research actlvltles now bemg carried forward under
 the National Cancer InstnWe should m no way be nnpeded or mter-
 rupted while plans are being made for the expansion, mtenslficatlon,
  and coordmatlon of the cancer research program,
      (6) Exlstmg research facllltles and manpower should be used as
  promptly as possible for the accelerated exploltatlon of the opportum-
 ties m the areas of special promise There 1s substantial unused capa-
  city m this country today that should be utlhzed m order to attract
  and retam the manpower that IS needed It 1s a myth that we could not
  spend effectively on cancer verv much more than 1s now being spent
  The fact that Federal sup ort for cancer research has leveled off smce
  1967 and that, due to m 2 atlon, the actual amount of work done has
  decreased has created a serious gap between what we are domg now
  and what we could and should be domg m cancer research It IS estl-
  mated that current expenditures could be doubled wlthm the frame-
  work of the exlstmg faclhtles and manpower potential of this country




                                      53
APPENDIX    III
      Page 11
                                                    6

            today, exclusive of the great mduqtrlal research capablllty m tlus field
            which should be brought to bear on an appreciable scale m high pnor-
            lty areas to which this type of capablllty 1s particularly         suIted
                (c) Exlstmg cancer centers should be strengthen and addltlonal can-
            cer centers m different palts of the country should be created The
            solution of the cancer problem lends itself to a multldlsclpllnary        eff art,
            where teams of highly quahfied speclahsts are avallable to interact on
           problems of research, both chmcal and nonclmlcal, teachmng, dlag-
            noses, preventive programs, and the development of Improved methods
           m the delivery of patlent care, mcludmg rehabllltatlon            Among those
            who work m the cancer field, there 1s great emphasis on the advantages
            of cmtlcal mass-a crltlcal mass of sclentlsts and physlclans commltted
           to the cooperatlve solution of the cancer problem, of research fac&tles,
            of patients, and of financial and other resources This IS snnply another
           way of saymg that the complehenslve cancer center offers the best
            orgamzatlonal structure for the expanded attack on cancer In addition
           to the few comprehensive cancer centers that exist 111the United States
           today, there are a number of other mstltutlons wbch combme all or
           most of the capabllltles for a multldlsclplmary        effort m cancer These
            could serve as a base for the creation of addltlonal centers The new
           centers should have appropriate geographic dlstrlbutlon             and should,
            wherever possible, be created where a nucleus of sclentlfic, professional
            and managemal personnel already exists and preferably where a um-
            verslty or a medical school afiillatlon exists or 1s planned
               In the creation of new cancer centers, manpower lmutatlons should
           be taken mto account, and new centers should not be created where
           there would be a dllutlon m the effectiveness of exlstmg centers which
           would offset any gam from the new center There should be a reallstlc
           opelatmg plan for each new center which assures the sclentlfic and
           managemal commitment and ablllty necessary to the creation and op-
           eration of a successful center
               It should be emphasized that the strengthemng            of exlstmg cancer
           centers and the creation of new cancer centers does not mean that
           under this program general responslbllltv         should be undertaken for
           the care of the Nation’s cancer patients The dellvery of patient care
           m cancer cases 1s a part of the general roblem of the delivery of
           patient care and should be so dealt with 2 owever, this mhlbltlon must
           not prevent the cancer centers from mcludmg such patient care faclll-
           ties as are necessary for clmlcal research and teachmg and for the de-
           velopment and demonstration           of the best methods of treatment m
           cancer cases
                (d) The cancer centers should also serve as admnnstratlve coordma-
           tors of those programs which require reeonal coordmatlon              Such cen-
           ters should support and assist clmlcs and commumty medlcal centers
           m their own geographic areas m order to assure the wldespread use
           of the best available methods for early detectlon and treatment of
           cancer They should also serve to collect data useful m the preventlon
           and cure of cancer, mcludmg patient follow-up mformatlon,                 and be
           responsible for the dlssemmatlon of mformatlon,           both at the lay and
           professional levels, that 1s useful m the prevention, diagnosis and cure
           of cancer The effective dlssemmatlon and utlllzatlon             of such mfor-
           mation is a most im ortant part of any natlonal plan to conquer cancer
               (e) A national p Ban of the type envisaged must take account of the
           manpower requirements for this effort There 1s a cntlcal need for




                                                  54
                                                                        APPENDIXIII
                                                                            Page 12
                                      7

trammg and career opportunltles for young sclentlsts, physlclans, and
other personnel m this program We must reaffirm to young mvestlga-
tors our confidence m the future of American science and m our na-
tional dedlcatlon to success m the conquest of cancer A manpower
program m this field should include trammv stipends, redoctoral fel-
lowshlps for particularly      prornismg candlaates, post croctoral fellow-
ships for brllhant mvestlgators, and career posltlons where appro-
priate through career mltlatlon awards, career development awards,
and semor career awards
     (f) A national plan for the conquest of cancer should provide for
 the generous use of grants as well as contracts and other methods of
 fundmg Thele should be mcreased emphasis on the grants mechanism
m order to stmmlate contmued independent exploration, particularly
 m those areas where knowledge 1s not su%clently mature for a co-
 ordinated program amed at reachmg defined obJectlves
     (4) A comprehenslve natlonal program reqmres optnnum commu-
mcatlon and centrallyed banks of mformatlon          There must be an accu-
rate and prompt mformatlon           flow m both dlrectlons This will call
 for mtegrated      data processmg, storage, and retrieval m order to
ratlonallze the declslon-making         and to make mformatlon        avallable
 when and where needed As mdlcated abole, the centers can be mlpor-
 tant foci m both the collection and dlssemmatlon of this mformatlon
     (h’) A cooldmated national program plan should, to the greatest
 possible extent, be generated bT the voluntarv productive mtelactlon
 and joint plannmg of the sclentlsts who will be responsible for domp
 the work The program should not be the result of the happenstance of
 a multitude of random declstons mdependently            al rived at An mte-
 elated and coherent plan resultmg from the lomt effort of representa
 tlve sclentlsts who will be responsible for its execution 1s fundamentallv
 dlffelent from the hierarchical lmposltlon or dnectlon of a research
  program from abot e However, the effective use of collective plannmg
  does not mean that centralized admmlstratlon        or management of re-
  sources should be sacrificed
     10 Ix”ulz&ng -The Committee estimates that a coordmated national
  program aimed at the conquest of cancer at the earllest possible time,
  as envisaged by the concurrent resolution of the Congress, would re-
  quire an appropriation     in fiscal 1972 of approximately      $400 mllllon
  Thereafter, the cost of the program nould increase at the rate of ap-
  proximately    $100 to $150 million per year, reachmg a level of $800
  mGon to $1 bllllon m 1976 These sums are not large m terms of our
  natIona resources or of the human suffermg and economic loss attllbut-
  able to cancer A program of the type helem recommended IS so nnpol -
  tant to the American people and to the world that we feel that the
  amounts called for should be provided even If tbs necessitates the
  ralsmg of addltlonal revenues It 1s of utmost nnportance that the
  financing of this program not result m cutbacks m other health
  programs
      11 Nutzonal Cancer Advzsory Board -Both          the public and the scl-
  entlfic commumtv must be effectively represented m this effort, and
  must have a part m its plannmg as well as its execution To this end, a
   National Cancer Advisory Board should be created with 18 members,
   nme of whom are dlstmgulshed sclentlsts and doctors m the field of
  cancer, and nme of whom are dlstmgmshed             laymen The members
   should serve for a term of 6 years with the terms of one-third of the
APPENDIXIII
    Page 13
                                           8

        men&21 9 clplnng      e’ el v Q
                                      d years Members of the Board should be
        appomtc(l b\ the Prcndent of the United States with the advice and
        consent of the Senate The Ghan-man of the Board should be elected by
        the members and should selve for a term of 2 years The Board should
        meet not 1~~sthan once each quarter and its function should be to advlse
        and ~~~1stthe Satlonal Cancer Authority and its Admmlstrator         m the
        development and e\ecutlon of the procram The Admmlstrntor           should
        be an eu-officlclo member of the Board The Board should have statu-
        tory responslblllty for the approval of each year’s program plan and
        budget, but the responslbllltv for admmlstermg       the program should
        rest with the Admmlstrator       The Board should have full mvestlpatory
        powers and should be required to report once each year to the Presl-
        dent and the Congress on the progress of the National Cancer Author-
        ity m the accomphshment of Its mlsslon This Board should supersede
       the presently exlstmg National Advisory Cancer Council, and the
        members of that Council should serve as addltlonal members of the
       Natlonal Cancer Bdvlsory Board for the duration of their present
       terms
           12 Cancer 1s an Implacable foe and the difficulty of ehmmatmg It as
        a ma-jar disease must not be underestimated      A top prlorlty commlt-
       ment by the Congress, the President, and the American people 1s
       required If we are to mount and sustam an assault on cancer of the
       magnitude envisaged by Senate Resolution 3’76 and the concurrent
        resolution of the Congress Such a commitment mvolves a recognltlon
        not only of the difficulty and complexlt    of cancer but also of the time
        and resources required to attack it e2 ectlvely While It IS probably
       unreallstlc at this tune to talk about the total elumnatlon of cancer
        within a short period of time or to expect a smgle vaccme or cure that
        will eradicate the disease completely, the progress that has been made
       m the past decade rovldes a strong basis for the belief that an accel-
       erated and mtensl Hed assault on cancer at this tune ~111 produce ex-
       traordmary     rewards The Committee IS unanimously of the view that
       an effective national program for the conquest of cancer should be
       promptly mlhated and relentlessly pursued

                                           0
                                                      APPENDIX IV
                                                           Page 1

                  DIVISION   OF RESEARCHGRANTS

                 NATIONAL INSTITUTES OF HEALTH

          LIST OF STUDY SECTIONS AS OF JULY 1, 1970

 1. Allergy    and Immunology Study Section
 2. Applied Physiology      Study Section
 3. Arthritis    and Metabolic    Diseases Program-Project   Commit-
    tee
 4. Bacteriology    and Mycology Study Section
 5. Biochemistry     Study Section
 6. Biomedical    Communications Study Section
 7 Biophysics     and Biophysical     Chemistry A Study Section
 8. Biophysics    and Biophysxal      Chemistry B Study Section
 9. Cardiovascular     A Study Section
10. Cardiovascular     B Study Sectlon
11. Cell Biology Study Section
12. Communicative Sciences Study Section
13. Computer and Biomathematical        Sciences Study Sectron
14. Dental Study Section
15. Developmental     Behavioral   Sciences Study Section
16. Endocrinology     Study Section
17. Epidemiology     and Disease Control Study Section
18. Experimental     Psychology Study Section
19, General Medicine A Study Section
20. General Medicine B Study Section
21. Genetics Study Section
22. Hematology Study Section
23. History    of the Life Sciences Study Section
24. Human Embryology and Development Study Section
25. Immunobiology Study Section
26. Medicinal    Chemistry A Study Section
27. Medicinal    Chemistry B Study Section
28. Metabolism Study Sectron
29. Microbial    Chemistry Study Section
30. Molecular Biology Study Section
31. Neurology A Study Section
32. Neurology B Study Section
33. Nutrition    Study Section
34. Pathology A Study Section
35. Pathology B Study Section
36. Pharmacology A Study Section
37. Pharmacology B Study Section

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APPENDIX IV
     Page 2

38.   Physiological      Chemistry Study Sectron
39.   Physiology     Study Sectlon
40.   Radlatlon     Study Sectlon
41.   Reproductive     Biology Study Section
42.   Surgery A Study Sectron
43.   Surgery B Study Sectlon
44.   Toxicology     Study Section
45.   Tropical   Medicine and Parasitology     Study SectIon
46.   Virology   Study Section
47.   Visual Sciences Study Section




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APPENDIX IV
    Page 2

38.   Physiological      Chemstry  Study Sectron
39.   Physiology     Study Sectmn
40.   Radiation     Study Section
41.   Reproductive     Brology Study Section
42.   Surgery A Study Section
43.   Surgery B Study Section
44.   Toxicology     Study SectIon
45.   Tropical   Medicine and Parasitology     Study Sectmn
46.   Virology    Study Section
47.   Visual Sciences Study Section




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