THE PLANNING AND 'MANAGEMENT OF RESEARCH
  AND DEVELOPMENT ACTIVITIES WITHIN EPA
A Report to the President and the Congress
   U.S. Environmental Protection Agency

             June 30, 1978

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                        EXECUTIVE SUMMARY





     This report describes a study conducted by EPA in response to a



directive contained in Section 7(c) of the Environmental Research, Develop-



ment, and Demonstration Authorization Act of 1978. Specifically, this study



has two objectives: 1) to determine the causes of the operational problems



identified in recent studies of EPA's research management process; and 2)



to develop specific corrective measures to alleviate these problems and



assure the most effective use of the Agency's substantial research and



development  (P.&D) resources.





     Two intra-Agency groups were formed last year to achieve these two



objectives.  The first group was a policy-level committee consisting of all



the Assistant Administrators, the Executive Director of the Science Advisory



Board and key Regional and laboratory representatives.  This group was



responsible  for overall direction and decision-making.  The second group



consisted of Agency-wide senior staff members, whose function was to



provide necessary analysis and support to the policy-level group.





     The analysis of the causes of the operational problems within EPA's



research management process revealed that the Agency lacked the following



fundamental  components: 1) a coherent research strategy which related



program objectives and priorities to research activities; 2) effective



communication and decision-making mechanisms between researchers and

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programs; 3) an adequate program of long term and anticipatory research;



4) adequately responsive research results; and 5) consistent research



quality.  In order to gain insight into the specific mechanisms which



might be used to alleviate these problems, the R&D management systems of



the Fish and Wildlife Service, the Nuclear Regulatory Commission, the



Food and Drug Administration, and the Occupational Safety and Health



Administration were examined.  Certain aspects of each of these systems



were incorporated into EPA's revised R&D planning and management system.



The policy group determined that the Agency's R&D problems have not



resulted from the way the R&D program is organized so no provisions for



major reorganizations are included in the revised system.





     The revised R&D planning and management system does, however, contain



five major components which differ significantly from previous EPA R&D



systems, and which are clearly linked to the five major deficiencies



identified above.  Specifically, these components are:





     1)  the identification of distinct research planning units around



         which coherent regulatory program/research strategies can be



         developed;





     2)  the establishment of permanent Research Committees for each



         research planning unit and a separate Research Oversight Committee



         composed of top EPA managers who will review strategy develop-



         ment and provide oversight throughout the R&D planning and imple-



         mentation cycle;

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     3)  the tying of R&D planning and management processes into Agency-



         wide management processes with decision rules focused on these



         connections;





     4)  a Research Incentive System designed to encourage responsiveness



         to Program and Regional research needs; and





     5)  the incorporation of peer review mechanisms throughout the plann-



         ing and management process to improve research quality.





     Sines tha revised system for R&D planning and management represents a



major departure from previous EPA systems, the policy-level group decided



that it should be tested on a pilot-study basis.  Five pilot projects were,



th*=-"pfore, initiated on March 15 and will be monitored closely for a six



month period.  The pilot areas include research activities in the areas of



drinking water, industrial wastewater control, mobile source air pollutants,



pesticides, and respirable particulate matter.  A report on the pilot-study



results will be provided to the Committee on Environment and Public Works



and the Committee on Science and Technology by October 31, 1978.  This



report will include a description of the experience of each pilot area,



recommended changes in the R&D planning and management system based on the



pilot experience, and steps undertaken to extend the approach to other EPA



research and development activities.

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              THE PLANNING AND MANAGEMENT OF RESEARCH
               AND DEVELOPMENT ACTIVITIES WITHIN EPA


            A Report to the President and the Congress


I.   INTRODUCTION


     A.  Purpose


         This report has been prepared in response to a directive contained

         in Section 7(c) of the Environmental Research, Development, and

         Demonstration Authorization Act of 1978. It also reflects more

         wide ranging efforts by EPA to improve its research management

         capabilities.
         The purpose of the report is twofold:
             (1)  To determine the causes of the operational problems

                  identified in recent studies of EPA's research management

                  process; and


             (2)  To describe the specific corrective measures that are now

                  being implemented in order to alleviate these problems

                  and assure the most effective possible use of the Agency's

                  substantial R&D resources.

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B.  Recent Activities

    Two intra-Agency groups were formed last year to address the
    various concerns that have been raised in recent years.  The
    first was a policy level committee consisting of all the Assis-
    tant Administrators, the Executive Director of the Science Advi-
    sory Board and key Regional and laboratory representatives with
    an interest in the coordination of program and research activity.
    This group was responsible for overall direction and decision-
    making.  The second group was at the working level and consisted
    of senior Agency staff members, whose function was to provide the
    necessary analysis and support to the policy-level group.  At the
    direction of the policy group, the staff had three major responsi-
    bilities:

        (1)  Identify current problems in the planning and
             management of R&D activities;

        (2)  Examine systems used by selected other agencies to
             plan and manage their R&D activities; and

        (3)  Develop organization and management options for the
             conduct of the R&D program at EPA.

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II.  ANALYSIS OF PROBLEMS





     A.  Summary of Problems





         The problems facing EPA's R&D program have been described and



         discussed by several Congressional committees, the National



         Academy of Sciences, and the Office of Technology Assessment and



         were confirmed by the EPA internal working group in  its review.



         These problems include insufficient attention to long-term



         anticipatory research, a general lack of responsiveness to



         the programs' regulatory concerns and the uneven quality of



         EPA research.





         An analysis was undertaken of each of these problems to determine



         the underlyirsn causes, looking particularly at the inadequacies of



         past EPA research planning and management systems.   A summary of



         this analysis is presented below.





     B.  Causes of Problems





         1.  Inadequacy of EPA's Program of Long-Term and Anticipatory



             Research





             Both the Committee on Environment and Public Works and the



             Committee on Science and Technology have expressed a special



             concern about the inadequacy of EPA's long-term  and anticipa-

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tory research program.  At the heart of this problem is the



need for a clear EPA commitment to devote a significant



part of its resources to well-thought-out research projects



which identify and address potentially significant environ-



mental hazards.





The appropriate balance between longer-term anticipatory and



shorter-term programmatic research is largely a matter of



experience and judgement. As described more fully below,



EPA's early experience was that of attempting to assimilate



pieces of existing programs and organizations while at the



same time trying to implement new legislation.  The urgency



of legislative mandates and the demands of forming a new



organizational structure combined to create an atmosphere in



which immediate concerns inevitably assumed priority over



long-range needs.





In the past EPA has tried to improve research management and



coordination by reorganizing various elements of its research



program and by introducing a number of different planning and



control methods.  While each of these changes was designed



to correct one or more perceived problems, one aggregate



result of so much change was to create the sense of continuing



instability, which promoted short-term problem solving, but



worked against a longer range perspective.

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Both the Agency and the Congressional Committees with over-



sight responsibility are now agreed  on the need to correct



this imbalance in EPA's research perspective.





2.  Unresponsiveness  The staff group identified the following



causes for allegations that the research program is unresponsive



to EPA's "regulatory needs: (1) inadequate future planning by



the regulatory programs;  (2)  inherent differences in perspec-



tive between research and program staff; and  (3) inadequate



communications between the two staffs.





Review of Agency program plans and interviews with Agency



program and research staff strongly indicate that the Agency



simply did not develop its program strategies in enough



detail and with specificity sufficient to permit identifi-



cation of research needs and priorities.  Early research



planning was characterized by solicitation of research ideas



from the regulatory program offices.  Although such a



relatively common approach did yield numerous "research



needs," it proved impossible to manage, since there was



no programmatic framework within which to assess potential



utility and to establish relative priorities.

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The second source of problems relates to the inherent
dichotomy between researchers and regulators.  Researchers
tend to approach problems from a longer-term perspective,
whereas regulators must focus on more immediate concerns.
Even when attempting to address immediate needs, researchers
often require long lead-times, both in conductinr and in
redirecting their research efforts.  Regu^cors, on the
other hand, are faced with immediat".-, often inflexible
deadlines which are established in legislation or court
decisions or which grow out of the need to address unantic-
ipated hazards.  Regulators demand a degree of respon-
siveness which is antithetical to a stable research
environment.

Furthermore, researchers, by training and in response to the
standards of the research community, are deeply concerned
with quality of the research.  Their motivation and pro-
fessional recognition is based on the quality, not the
timing of the work.  Regulators, however, are primarily
interested in the timeliness and utility of information.
They are sometimes forced to make judgments on the basis of
the data which is available at the time the decision has to
be made.

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Thus, an inherent set of tensions is created because of



different professional experiences of and demands on



researchers and regulators.  While these tensions can



never be fully resolved, they can be brought into a



reasonable balance that best supports the Agency's



regulatory mission.





Finally, and perhaps most significantly, there were few



effective communications channels at the appropriate oper-



ating levels of the organization.  Effective linkages



between laboratory directors and their research staffs with



relevant program divisions and regional offices often did



not exist.  The complex, discipline-oriented organizational



structure of the Office of Research and Development (CED),



with its fifteen laboratories, complicated communications



problems.  While the discipline orientation is not an



insuperable problem itself, the lack of organizational



alignment with the structure of the regulatory program



offices tends to exacerbate the communications problems.



Without a systematic planning and management process to



compensate for these organizational complexities, decisions



have often been forced to the top of the organization, often



to the Assistant Administrator level, for resolution.  But

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                          8






    because of the limited time of top management to respond to



    the demand for ad hoc problem solving, many problems are



    simply never resolved, adding further to perceptions of



    unresponsiveness and organizational isolation of ORD



    within the program and regional offices.





    Because of these long-standing communications problems, there



    is great skepticism within the Agency as to whether any



    research management system can function effectively.  Fears



    of paper-intensive planning systems, of undelivered promises



    from ORD, of the unwillingness or inability of the regulatory .



    programs to pay sufficient and knowledgeable attention to



    identifying their research needs, of the conduct of "closet"



    research by the program offices, and of th>e Continued



    "isolation" of ORD from the rest of the Agency reflect a



    history which must be appreciated in order to be overcome.





3.  Uneven Quality of Research.  Under these circumstances the



    review, evaluation and quality control of research activities



    has been extremely difficult.  This has resulted in the



    dissemination of research results of uneven quality.  Also



    complicating the problem of obtaining high quality research



    are the inter-related problems of attracting and keeping



    highly qualified staff within the constraints of civil service



    salaries and rules and requiring that senior staff assume



    supervisory duties in order to be promoted.

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        This report addresses the research quality issues that can



        be impacted by the planning and management process.  The



        research personnel issues are being addressed in an associated



        study of EPA's overall personnel management efforts.





C.  The Changing Situation





    A brief look at the history of EPA shows that the atmosphere for



    program and research coordination has changed significantly over



    the last seven years.  During its early years, EPA tended to



    operate in a crisis mode.  The enactment of a continuous stream



    of new legislation during EPA's formative years demanded that



    the top Agency priority be the development and implementation of



    regulations.  This occurred while EPA was simultaneously attempt-



  "• ing to integrate a diverse set of programs and administrative



    units into a viable and rational new organization.  While the



    research effort contributed vital information during this era



    and provided expert witnesses for judicial proceedings, much of



    OFD became increasingly detached from regulatory concerns and



    came to be viewed as a bystander while the program and regional



    offices struggled to put the major regulatory building blocks in



    place.






    Today, the legislative mandates of EPA are relatively stable.



    All parts of the Agency have attained greater organizational



    maturity.  More time can now be devoted to the interaction of

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                              10

    research with the regulatory efforts.  Furthermore, the exper-
    ience gained in the early years of the Agency's existence has
    brought about a change in perspective that will be of great
    assistance in this effort.  A. heightened awareness of the
    importance of timely, credible research is developing.  There
    is also a recognition of the need to use the Agency's research
    resources more effectively.

    Finally, and most importantly, top management now has a commit-
    ment to manage the Agency.  Research management is only one of
    many activities under careful scrutiny.  A wide range of reforms
    are now being proposed and implemented which include regulatory
    reforms, ZBB process improvements and personnel management
    reforms.  The reform of the research management process is a
    significant element in this agenda for action.

D.  Relating Solutions to Problems

    In order to have impact, proposed solutions must be directly
    related to, and able to solve, the problems being addressed.
    While this seems obvious, organizational solutions are pre-
    scribed, more often than not, when, in fact, the underlying
    problems call for quite different remedies. This analysis
    includes a careful linking of identified problems with proposed
    solutions.

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                          11

The lack of a programmatic context for environmental research
calls for the development of a coordinated program/research
strategy.  Only then can major goals and objectives be iden-
tified, coherent plans developed and implemented, and results
evaluated.

The lack of adequate communication channels and decision-making
procedures underscores the need for structured and meaningful
interactions among the appropriate research, program, and
regional staff, as well as outside experts.

The inadequacy of the current program of exploratory research
calls for provisions in the planning and management process to
protect and enhance those longer-term efforts which have the
potential to help solve future environmental problems.

The perceived inadequacy of research findings in terms of
usefulness and timeliness calls for innovative approaches through
which program and regional offices can assure responsiveness to
their regulatory and enforcement needs.

Finally, the uneven quality of research results emphasizes the
need for qualified peer review of research plans, protocols, and
findings—in fact, that quality must be built into each step of
the research planning and management process was an inescapable
conclusion.

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                         12
The following matrix summarizes the results of our analysis.
             Problem
                                         Corrective Action
    Lack of research strategy   	  Program context for
                                     research management
    Lack of adequate communi-
    cations and decision-making

    Inadequate program of long-
    term anticipatory research


    Inadequately responsive
    research results
                                         Communications and
                                         problem solving at
                                         operational levels
                                         Protection of  long-
                                         term research activi-
                                         ties

                                         Greater program and
                                         regional influence and
                                         responsibility

                                         Incorporation of peer
                                         review throughout planning
                                         and management process

E.  Review of Systems Used in Other Agencies

    In order to gain insight into the specific mechanisms which might
    be used to address the problems identified above, the R&D planning
    and management systems used in four other regulatory agencies were
    examined:
    Uneven research quality    	

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                        13





    •  Fish and Wildlife Service (FWS)



    •  Nuclear Regulatory Commission  (NEC)



    *  Food and Drug Administration (FDA)



    •  Occupational Safety and Health Administration  (OSHA)





For each agency, the review consisted of two components:



1) interviews with key staff in the research office,  in a



program office, and in an administrative or planning  office;



and 2) an examination of relevant agency documentation such as



organizational charts, functional statements and planning



manuals.





As shown in Table A, the missions of  these four agencies are



quite different.  There are also fundamental differences in the



way each agency obtains R&D support for its programmatic activi-



ties.  In FWS, control of R&D funds rests with the program



offices while all research is performed by FWS's research



office.  The NRC, on the other hand, gives funding control for



R&D to its research office which in turn "contracts"  with the



Department of Energy (DOE), where most of the work is performed.



At FDA, R&D responsibilities are assigned to the program offices,



which have their own research labs.   Finally, OSHA, which is



part of the Department of Labor, essentially has no research



capability.  Instead, OSHA relies on HEW's National Institute of



Occupational Safety and Health  (NIOSH) for the research needed



to support its activities.

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                         14





While it was determined that it would be impractical and  inappro-



priate for EPA to adopt any of these R&D systems j.n toto, there



are features of each model which were found to be of significant



merit and were therefore incorporated into the design of  EPA's



new R&D planning and management system.  Table B presents a



summary of the major features of each agency's R&D planning and



management process.  Those features which are particularly



relevant to EPA's R&D concerns are marked with asterisks.  These



are the features that best addressed the basic problems identified



above.
1.  Program/Research Strategies.  The review of the four



    indicated that none of their R&D plcinning and management



    systems had evolved to the point where future planning such



    as required for the development of well-coordinated strategies



    was consistently being performed.  Some, however, do have



    formal planning procedures which show particular promise for



    EPA.  At NIOSH, the Director prepares a yearly research



    strategy in cooperation with an OSHA-NIOSH policy group.



    However, the strategy is quite broad in scope.  EVJS, on the



    other hand, requires its program managers to prepare detailed



    strategy papers during the ZBB year which specify program

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                          15





    objectives and required R&D support. These strategies are



    relatively narrow in scope since they relate only to one



    program manager's area of responsibility;  If a middle



    ground could be found between these two forms of strategy



    development, a viable method of preparing well-coordinated



    program/research strategies could be developed.





2.  Communications Between Researchers and Programs.  Each



    agency examined had at least one mechanism in place for



    resolving problems between program office and research



    managers. The mechanism employed by NRC appears to us to



    be the most adaptable to EPA's situation.   Specifically,



    NRC uses standing Research Review Groups which meet on a



    periodic basis to resolve policy and technical issues



    encountered in the research program.  Each Research Review



    Group, which consists of high level staff from the program



    offices, the research office, and DOE laboratories, is



    responsible for reviewing a particular research area.  The



    Research Group is also assisted by outside experts.





3.  Ways to Assure Responsiveness and Protect Long-term Research.



    Since responsiveness of research to program needs and the



    maintenance of long-term research capabilities are inter-



    dependent, both will be discussed here.  The mechanism



    used in EV7S offers one method for ensuring research respon-

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                           16





    siveness.  PWS gives R&D funding control to its program



    offices.  EWS feels that this arrangement gives the program



    offices a vested interest in research since they must take



    responsibility for seeing that R&D funds are spent on research



    which supports their needs.  At the same time, the researcher



    feels the incentive to be responsive since funding could be



    withdrawn if he does not perform in accordance with the



    program's requests.





    FVJS has no formal mechanism for protecting long-term research.



    However, agency staff stated that there is an informal under-



    standing that some of the program offices' R&D funds will,



    in fact, be spent on long term research.





4.  Research Quality.  Maintenance of a consistent quality of



    research is a goal that is not unique t^ *-he four agencies



    examined or to regulatory agencies in general.  Each of the



    four agencies does have a procedure to be followed in the



    evaluation of research (Table B).  Some of the agencies also



    have procedures established to ensure transfer of research



    results.  For example, at the NRC following the evaluation



    of research, a Research Information Letter (RIL) is prepared



    which includes a brief technical description and identifica-



    tion of the user need, an executive summary of principal

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                               17






        results and their significance to NRC, and a concise descrip-



        tion of the evaluation of the results including the range of



        applicability.





F.  Analysis of "Organizational Solutions"





    In reviewing the organizational arrangements in other agencies and



    in EPA, the issue of a possible reorganization of the EPA research



    program was addressed.  Both centralized and decentralized systems



    were analyzed.  While there are advantages and disadvantages to



    each approach, the critical issue becomes whether or not the



    problems facing EPA's R&D program have resulted from the way it is



    organized.  The Policy Group reviewed a number of options for R&D



    in EPA which paralleled the organizational arrangements in other



    agencies, but ultimately rejected them.  The reasons for rejecting



    options requiring reorganization were:





        o  Current organizational arrangements are not at the core



           of the problems facing the Agency's R&D effort.





        o  ORD has, in its short existence, already gone through



           several reorganizations, each with an increasingly



           severe impact on morale.





        o  A reorganization always disrupts ongoing activity.  VJhen



           that ongoing activity consists of research projects typi-



           cally lasting two to four years, the potential costs in

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                          18






       terms of projects that are aborted or seriously disrupted



       is considerable.





    •  In examining the possibility of reorganizing EPA's research



       function along program lines in a manner similar to that of



       FDAf it was found that:





       - Such a reorganization would be hindered by EPA's large



         number of geographically dispersed laboratories and by



         the fact that many are simultaneously supportive of



         several different programs.





       - A decentralized research program such as FDA's may



         result in duplication of research effort.





    •  EWS's, and to a certain extent NRC's, organizational



       arrangements are similar to EPA's.





    e  The OSHA/NIOSH arrangement where research and operational



       programs are located in separate Departments does not



       seem to offer a useful model for enhancing the responsive-



       ness of research activities to regulatory needs.





The Policy Group, in rejecting solutions which were dependent on



major reorganization, asked rather that management system changes



be proposed which would bring about the desired improvements in



the functioning of the Agency's research program.

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                                  19
III.  RECOMMENDED SYSTEM





The system that is being recommended for implementation in the planning and



management of research and development in EPA has five major components:





     1)   the identification of distinct research planning units based on



          regulatory programs;





     2)   the establishment of permanent Research Committees for each



          research planning unit and of a separate Research Oversight



          Committee composed of EPA's top management;





     3)   the tying of R&D planning and management processes to Agency-



          wide management processes with decision rules focused on  those



          connections;





     4)   a Research Incentive System designed to assure responsiveness to



          program and regional research needs; and





     5)   the incorporation of peer review mechanisms throughout the



          planning and management process to improve research quality.





These design features are directly linked to the five major problem areas



identified earlier  (See Table C).  Each of these features is discussed in



detail below.

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                                  20





A.  Research Planning Units





    This analysis has shown that many of the problems associated with



    EPA's R&D program would be alleviated if a set of carefully laid-out



    regulatory program/research strategies were to be developed around a



    logical planning framework.  The conceptual basis for the EPA R&D



    planning and management system will be clusters of R&D activities



    which, because of their inherent interdependencies, should be planned



    and managed as a unit.  The following are examples of possible



    research planning units:



         •  hazardous air pollutants



         •  toxic pollutant control



         •  nonpoint source pollution control



         *  hazardous waste disposal



         •  safe drinking water





    In many cases, research planning units will be "multi-media" and will



    cross program lines or research category and budgetary boundaries.



    "Toxic pollutant control" is an obvious example since three program



    offices have a stake in this area of research activity.  Within these



    research planning units, major goals and objectives can be defined



    and relative roles and responsibilities for the conduct of research



    clarified.  It is expected that 15-20 such research planning units



    will eventually be identified with each having $10-25 million in



    resources.

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                                   21





B.  Research Committees





    In order to facilitate effective communication between ORD, Program



    Offices, and Regions in overseeing the planning and conduct of



    research during ZBB, planning, and implementation years, Research



    Committees will be established for each research planning unit.  Each



    Research Committee will be chaired by a Research Manager designated



    by ORD and will have representatives from relevant client offices



    (Program Offices and Regions).  Regional representatives will be



    selected by the Regions collectively. The services of experts from



    other Agencies and from outside the Federal Government will also be



    used.





    Each Research Committee will  be a permanent body with continuing



    responsibilities throughout all phases of the R&D cycle.  Specifically,



    the Research Committee will be responsible for:





         •  developing a multi-year research strategy which is based



            on the relevant regulatory Program strategy, and which



            identifies Agency research goals and objectives as well as



            broad Program and Regional research output requirements,





         •  reviewing and suggesting appropriate modifications in related



            ORD, Program Office and Regional ZBB decision units which



            include research components in order to assure their respon-

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                                 22






        siveness to approved research strategies and their consistency



        with regulatory components of those same and other decision



        units;





     •  analyzing relevant research decision units in the ZEB process;





     •  monitoring progress during the planning and implementation



        years against approved strategies and implemention plans and



        suggesting corrections for significant deviations to the



        relevant ORD unit;





     •  serving as the primary forum for resolving R&D issues encoun-



        tered by the Program Offices, the Regional Offices, or ORB



        during the planning and implementation years, or if unsuccessful,



        referring the issues to the Research Oversight Committee;





     •  as time allows, reviewing and evaluating research results; and





     •  as time allows, recommending the appropriate timing and means



        for disseminating specific R&D products.





     The Research Committees, however, will act in an advisory capacity



only and will raise major unresolved issues to the Assistant Adminis-



trator for Research and Development, who will negotiate a resolution



with the appropriate Assistant and Regional Administrators.  Issues still



unresolved will be raised to the Research Oversight Committee.  Research

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                                  23


    Committees will not assume the operational responsibilities of ORD, the

    Program Offices, or the Regional Offices.  The development of Program

    strategies, ZBB decision units, implementation plans, project workplans,

    routine project evaluation, etc., will remain line management responsi-

    bilities.


     Research Committee Purview.  Research and development activities in

     EPA are grouped into three basic categories, not all of which may be

     relevant to any particular research planning unit.  These categories

     are defined as follows:



     a.  Exploratory R&D* — research which is conducted primarily for the

         purpose of developing fundamental knowledge and principles appli-

         cable to the solution of currently intractable problems or scien-

         tific questions, or research which is aimed at identifying or

         understanding environmental problems on the horizon for which no

         specific regulatory activity is currently contemplated.


     b.  Regulatory/Operational Support R&D—research in response to

         identified program or regional office operational requirements,

         or research designed to test current Agency, Program or Regional

         assumptions but which is not immediately required in support of
* The Exploratory category will include, but not be limited to, the Anti-
  cipatory Research activities funded under the Interdisciplinary budget
  category.

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                              24





    planned regulatory actions.  It also includes technical assistance



    support services 	 in response to ad hoc needs or special



    requirements that cannot be planned in detail during normal



    budgeting and planning cycles.





c.  Assigned Mission R&D—research in response to missions speci-



    fically assigned to EPA by Congress, the White House or OMB beyond



    the general requirements of the Agency's enabling legislation.



    Examples include the Interagency Energy/Environment Program and



    the Biological and Climatic Effects of Radiation (BACER) Program.





Most Research Committees will be responsible for research which is



primarily regulatory/operational support in nature.  Nevertheless,



these Committees will be expected to address relevant activities from



all research categories that fall within the purview of the Committee's



research planning unit.  This will include appropriate portions of the



Exploratory R&D and Assigned Mission R&D categories.





In addition, the Office of Research and Development will establish



Research Committees for the Exploratory R&D and Assigned Missions



R&D categories.  These two Research Committees, which will be



chaired by the Assistant Administrator for Research and Development,



will include Program and Regional representatives and draw on



outside experts for consultation.  The jurisdictions of these two



committees will partially overlap with those of the other Research



Committees.  (See Table D).

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                              25





In addition to conducting their own independent deliberations, the



Exploratory and Assigned Mission Research Committees will receive



recommendations from the other Research Committees and will integrate



them into their priorities.  The Exploratory R&D Committee will also



receive and incorporate recommendations from a "bottom-up" planning



process as called for in the report of the National Academy of Sciences,



Such a process would allow laboratories and bench-level scientists to



propose implementation of specific longer-term research projects.





In the case of Assigned Mission R&D, the Research Committee will



assure the consistency of its recommendations with priorities set by



Congress, the White House, and OMB.  As with all Research Committees,



the activities and recommendations of these last two Committees will



be subject to review by the Research Oversight Committee  (see below).







The Office of Research and Development will normally be responsible



for the detailed planning and implementation of projects  in the



Exploratory and Assigned Mission categories.  However, when changes



are made in the programs in either of these categories which might



directly or indirectly affect Regulatory Support R&D, it  is the



responsibility of the Assistant Administrator for Research and



Development to inform the affected Research Committees.

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                                   26





     In addition to the Research Committees, a Research Oversight Committee



     composed of the Assistant Administrators and of those Regional Adminis-



     trators named by the Deputy Administrator will also be established.



     It will be chaired by the Assistant Administrator for Research and



     Development and have general responsibility for reviewing the activi-



     ties and recommendations of all Research Committees and for resolving



     all issues that cannot be resolved at lower levels.  Specifically, it



     will be responsible for:





         o   reviewing and approving multi-year strategies developed by



             Research Committees;





         o   giving overall policy direction to the Research Committees



             and to the Agency with regard to research activities and



             resolving major operational problems regarding the conduct



             of research or research planning; and





         o   overseeing, with the Science Advisory Board, evaluation by



             the Research Committees of research products and, as neces-



             sary, reviewing and approving Research Committee recommen-



             dations regarding the appropriate timing and means for



             disseminating research products.







C.  Integration of R&D Management and Planning with EPA Planning Process





    It is considered crucial that the planning and management system for



    R&D be carefully tied to the ongoing management system of EPA and that

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                             27





clear well-defined decision rules be applied.  Some of these decision



rules will act to foster long-term research and assure its relevance to



potentially significant regulatory needs.





The following section describes the relationship of the new R&D planning



and management System to the Agency strategy formulation and ZBB



processes and to planning and implementation activities.





 1.   Pre-ZBB Strategy Development.  Each Research Committee will



 develop a strategy that addresses all phases of the relevant



 research activity.  The research strategy will delineate the major



 goals and objectives for the relevant areas of research activity.



 Such a research strategy will, whenever possible, be developed



 within the context of a pre-existing program  strategy.  Outside



 experts will be asked to play a significant role in the development



 and evaluation of this strategy.  All EPA research funds (e.g., ORD,



 Program, Regional) will be encompassed in the research strategy



 document as appropriate.





 Prior to the development of multi-year research strategies by the



 Research Committees, it will be necessary for the Program and



 Regional Offices to have carried out the following preliminary



 activities:





      •  prepare an inventory of all statutorily mandated or court



         ordered program requirements and of all other specific program



         needs,

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                              28





      •  prepare a timetable of required completion dates for each of



         the above activities,





      •  identify all technical information needed to carry out the



         above activities, and





      •  identify all information gaps and the time frame within which



         these gaps must be filled.





 This last item will be the major Program/Regional input to the Research



 Committees' strategy development process.





Completed strategies will then be reviewed and approved by the



Research Oversight Committee.  The Assistant Administrator for



Research and Development, with the advice of the Research Oversight



Committee and after consultation with the Administrator, will define



the general resource levels by planning unit, for the Exploratory R&D



and Assigned Mission R&D categories.





2.  ZBB.  The R&D elements of the ZBB decision units will be based on



the specific research planning unit strategies developed by the



Research Committees.  They must also be consistent with any associated



program decision units.  Program decision units should, if possible,



be drafted prior to the drafting of research decision units.





3.  Planning Year.  Detailed research planning and execution in



response to approved strategies and objectives will normally be the



responsibility of ORD.  Accomplishment plans for R&D activities will

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                              29
be prepared by ORD or the responsible Program or Regional office and



submitted to the Research Committee for review and comment.  Reorien-



tation of the plans, as appropriate, will be recommended to ORD or



the other responsible office by the Research Committee.  In the case



where Program or Regional Offices wish to implement specific extramural



R&D activities independently, ORD will be given the opportunity to



review the research proposals to determine if there is any duplication



with past, ongoing, or planned ORD activities, and to comment on the



technical quality of the proposed activities.





Finally, under the Research Incentive System, a portion of the research



funds may be allotted to a Program or Regional Office rather than to



ORD.  When this does occur, ORD will, within agreed-upon time constraints,



be given adequate opportunity to negotiate for the opportunity to



conduct that research intramurally or to provide contract monitoring



services to the sponsoring Program or Regional Office.  If the Program



or Regional Office accepts ORD's offer, the management details  (costs,



timing, form of output) will be negotiated between ORD and the client



office.





4.  Implementation years.  The Research Committees will review progress



periodically in response to the research strategy and implementation



plans during the implementation phase of the R&D cycle, and report on



an exception basis to the Research Oversight Committee.

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                                  30





    As time allows, the Research Committees will also review and evaluate



    results in terms of technical quality and operational responsiveness.



    Both Agency and outside experts will be used to conduct such reviews.



    The Research Committees will also, as time allows, identify the



    appropriate timing and method of dissemination of specific R&D



    outputs.







D.  Research Incentives System





    The Research Incentives System (RIS) will constitute an important



    element of the proposed R&D planning and management system.





    The primary purpose of the RIS is to establish a mechanism to encour-



    age ORD to be responsive to Program and Regional needs and to encourage



    Program and Regional Offices to take seriously their responsibilities



    for clearly articulating their research needs and for following the



    progress of key research projects.  The RIS would establish a client-



    contractor relationship between ORD and the Program and Regional



    Offices.  It would require ORD and Program and Regional Offices



    to work together effectively to avoid the results of failure—loss of



    research resources by ORD, and assumption of day-to-day research



    management duties by the Programs or Regions.





    We are now considering a number of variants of the RIS, one of which



    will be discussed for illustrative purposes.  During strategy develop-



    ment, Program and Regional Offices would identify areas of research

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                             31






that they feel they should more closely manage because those areas



are key to the success of their regulatory efforts in the near-term.



Program and Regional Offices, with the assistance of ORE), would



develop appropriate proposals to incorporate into the ZBB decision



units.  The ZBB ranking process would then be used to determine the



relative priority of such proposals.





Based on ZBB decisions and Congressional action, implementation plans



for activities assigned to Program or Regional Offices would be



developed by those Offices.  The Offices would then negotiate with



ORD to conduct the research within its laboratories or to provide



contract management services for the Program/Regional Office projects.



Alternatively, the Program/Regional Offices, after consultation



with ORD, could contract directly with outside firms to conduct the



desired research.





Through judicious use of the RIS, all managers - Assistant Administra-



tors, Deputy Assistant Administrators, and Division Directors - can be



given a greater say in project direction for those projects that will



contribute significantly to meeting their program needs.  The effect of



establishing a Research Incentive System will therefore be to enhance



the impact of the Research Committee System in promoting openess and



responsiveness in communications between research managers and program



managers at all three management levels.

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                              32






In order not to overshadow the positive effects of increased research



responsiveness which would grow out of this system, however, it  is



necessary to build in safeguards against potentially negative conse-



quences.  To avoid undue instability in ORD research efforts, it



could be specified that a percentage of research funds managed by ORD



in the previous year would continue to be managed by that organization.



For example, the Program/Regional Offices could be required  to  spend



90% of those funds within ORD.  Further limits could be placed on the



extent of reprogramming of ongoing projects by the Program or Regional



Offices without the concurrence of the Assistant Administrator for



ORD.  Since the Research Incentive System would be operated within



the context of agreed-upon research strategies, ZEE decision units



and implementation plans, changes in program emphasis or direction



would not be made beyond those necessitated by unanticipated needs.





Such an approach to the Research Incentive System would have obvious



benefits for the Program and Regional Offices which depend upon



research findings for their regulatory efforts.  These Offices could



participate as they chose in the development and approval of research



protocols, thereby enhancing the likelihood that the outputs will be



specifically tailored to their needs.

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                                   33






    ORD also has much to gain from a Research Incentive System.  Under



    the current arrangement, requests for new research support are often



    made to ORD without regard to the relative priority of those requests



    and without a sense of what research activities are delayed or disrupted



    by the new requests.  The new system instead requires that the Programs/



    Regions articulate and set priorities among the requests that they make



    of ORD.  By allowing ORD to choose whether or not to "bid" on key



    projects, the RIS will allow ORD to set its prices competitively in



    order to develop in-house research capability, especially in emerging



    areas.





    Clearly, whatever variants are selected by the pilot studies, the RIS



    will have to be applied flexibly in order to meet the special condi-



    tions of each research planning unit.  In general, however, growth



    areas or those with many short-term projects can probably respond



    most effectively to such a system.







E.  Research Quality.  The incorporation of peer review mechanisms



    throughout the planning and management process is fundamental to the



    success of the proposed R&D planning and management system.  Each



    research committee will use such mechanisms during the planning,



    implementation, evaluation and dissemination stages of research.



    Committees will address the following questions:

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                                 34





         How should  "technical quality" be measured?





         What is the appropriate mechanism•for making the trade-off



         between timeliness of response and thoroughness of analysis?





         How and by whom should the product of research be presented to



         the client/user?





         What mechanisms should be used to ensure that researchers receive



         feedback on the timeliness, quality, and utility of the products



         of ongoing or completed research efforts?







IV. ACTIVITIES UNDERWAY TO IMPLEMENT THE SYSTEM





    The Policy Group, after agreeing to the R&D planning and management



    approach decribed above, concluded that it would be prudent to test



    the system in several pilot projects.  In this way, the many facets



    of the system can be thoroughly tested and modified or possibly rejected



    in order to increase the prospect for the system to work effectively



    as it is applied to other parts or all of EPA's R&D program.





    Five pilot areas have been selected.  They represent five "natural"



    areas of research planning which are of major importance in EPA's



    regulatory and research efforts.  They include one area (respirable



    particulates) which both is specific to a regulatory program (air



    quality) and cuts across all areas of research disciplines.  The

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                             35






other four are also specific to a single regulatory program but



are concentrated in only one or two research disciplines  (drinking



water, industrial wastewater control, mobile source air pollutants



and pesticides).





The jurisdiction of each of the five pilots falls within  the boun-



daries of a single Program Office but this need not always be the



case.  When the pilot project is completed and additional Research



Committees are established to cover the bulk of EPA's research



activity, some Committees may have responsibilities which cross



program boundaries.





During the pilot period, the recommended R&D planning and manage-



ment system is being applied within each of the five pilot areas.



The Research Committee established for each pilot is composed



of relevant ORD, Program, and Regional staff and will be  assisted



by outside experts.  Each Research Committee will develop a brief



research strategy, participate in the 1980 ZBB process, and review



and, where appropriate, make recommendations for reprogramming of



research activities planned for FY-79 and of research underway in



FY-78.  To the extent possible, variants of the Research  Incentives



System will be tested.





The pilot projects were formally initiated on March 15, and will be



monitored closely for a six-month period.  A report on the pilot



experience will be provided to the Congress by October 31, 1978.

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                               36






This report will include a description of the experience of each



pilot study, recommended changes in the R&D planning and management



system based on the pilot experience, and steps taken to extend the



system to other parts of EPA's research and development activities.

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    AGENCY
                          Table B.
         STRATEGY
        DEVELOPMENT
                                            ling
Features of R&D Planning and Management Systems Used in Target Agencies

        R&D PLANNING AND MANAGEMENT PROCESS
               ZBB
    PLANNING
  IMPLEMENTATION
   EVALUATION
III. FDA  O
Program managers within
the bureaus recommend
program goals and objec-
tives.  Subject to
concurrence by the bureau
management, the plans
are prepared and
presented to the
Commission during the
planning process as
the Bureau's Proposed
Accompli slime nt Objec-
tives.
    o PMS updated annually
      to assure coverage of
      problem areas
    o Level of effort for
      R&D defined during
      the Accomplishment
      Objective phase of
      the Planning Process
      prior to ZBB.
    o Program managers
      prepare decision
      units.
o "Bottom -up"
  mechanism for
  surfacing and
  ranking R&D
  proposals.
  along with
  all other
  programmatic
  proposals.
o Office of
  Planning and
  Evaluation and
  Office of
  Administration
  identify
  allocation
  decisions for
  Commissioner
o Commissioner
  designates
  fiscal year
  priorities
  and deter-
  mines needs
  for real loca-
  tion of finds.
o Detailed plan-
  ning performed
  by program
  managers.
o All research
  implemented by
  program office
  labs, one or more
  of the 20 field
  labs, or NCTR.
Face-to-face brief
ing of Commissione
and his top staff
by prog ran manager
on program accom-
plishments.

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                     Table B.  Features of R&D Planning  and Management Systems Used  in Target Agencies
                                            R&D PLANNING AND MANAGEMENT PROCESS
                       STRATEGY
    AGENCY            DEVELOPMENT

IV. OSHA/     *  Research development
    NIOSH        performed by NIOSH
                 Director with inputs
                 from OSHA-NIOSH Policy
                 Group
       ZBB

Management Commit-
tee chaired by
NIOSH Director
and composed of
top NIOSH officials
appoints members
of Program Commit-
tee for Coordinat-
ing Research (PCCRs)
PCCRs surface
research needs,
and "weed out"
duplicative
research
NIOSH Division
Directors pre-
pare decision
units
    PLANNING

o Appropriate
  NIOSH Research
  Division
  Directors do
  detailed plan-
  ning but must
  get PCCR
  agreement on
  outputs for
  allocation of
  funds and
  positions
    IMPLEMENTATION

o All research
  implemented by
  appropr iate
  NIOSH Research
  Division
o PCCR reviews
  interim outputs
  and progress
  reports
o OSHA representatives
  are also invited
  to participate in
  PCCR reviews
     EVALUATION

*OSHA-NIGSH workit
 Groups evaluate
 quality and
 responsiveness
 of research prod-
 ucts and brief
 OSHA officials.

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                 Table B.  Features of R&D Planning and Management Systems Used in Target Agencies
                                        R&D PLANNING AND MANAGEMENT PROCESS
AGENCY
      STRATEGY
     DEVELOPMENT
      ZBB
  PLANNING
 IMPLEMENTATION
   EVALUATION
NRG/DOE   O
Coordinators designated
by program offices to
oversee identification
of research needs
Coordinators "weed
out" unnecessary
duplication
and coordinate
actions required
to arrive at
agreement on
proposed research
Research proposals
submitted to
Office of Nuclear
Research (RES)
RES rules on
validity of pro-
posals; Programs
have appeal
rights to Execu-
tive Director
RES prepares
decision units
* RES does all
  planning but
  must have pro-
  gran office
  "sponsor"
  before plans
  can be final-
  ized
* Standing Re-
  search Review
  Groups, (RRGs)
  of high-level
  staff from pro-
  gram offices,
  RES labs, other
  agencies and
  outside experts
  act as over-
  sight panels
  on technical
  problems
  encountered dur-
  ing the planning
  year
o RES manages all
  research projects
                                                                                 * RRGs reviews
                                                                                   interim outputs
                                                                                   and progress
                                                                                   reports
o RES Assistant
  Director chairs
  committee conpos-
  ed of prograu
  offices and RES
  representation
  and which may
  include members
  of RRG and out-
  side experts to
  review respon-
  siveness of
  research

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                          Table B.  Features of R&D PlannH^ and Management Systems Used in Target Agencies
                                              R&D PLANNING AND MANAGEMENT PROCESS
    AGENCY
        STRATHGY.
       DEVELOPMENT
          ZBQ
   PLANNING
    IMPLEMENTATION
    EVALUATION
I.  FWS
Program strategy state-
ments prepared by program
managers on a year-to-
year basis
* "Bottom up" and "top
  down" mechanisms
  for surfacing R&D
  proposals to support
  strategy
* Program Manager
  Strategy Papers
  prepared by program
  to show which R&D
  projects support
  program objectives.
* Associate Director
  for Research
  "costs out"
  proposals

* Decision units
  prepared by area
  and regional
  offices
o Detailed
  project
  planning
  performed
  by Research
  Office with
  from program
  offices
*A11 research funds
 assigned to Program
 Managers

o Program advice pre-
  pared by Program
  Managers which makes
  funds available to
  Research Office
o Formal program
  reviews every 6
  months
o Progran review
  of completed
  research every
  6 to 12
  months

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                                   Table A.  Target Agencies^ for R&D Program Analysis
   AGENCY
   MISSION
  AGENCY ORGANIZATION
                                                                              R&D PROGRAM CHARACTERISTICS
FUND
CONTROL
IMPLEMENTATION
RESPONSIBILITY
   Fish and Wildlife
   Service (FWS)
To conserve the
Nation's fish and
wildlife resources
 Three Program Offices,
 Six Regions and the
 Alaska Area Office
 (which include approx-
 mately 600 field
 stations) report directly
 to the Director of FWS
 in Headquarters.
Assigned to
operating
progran
managers in
Headquarters
Centralized under
the direct control
of the Associate
Director for Research
in Headquarters
I. Nuclear
   Regulatory
   Commission
   (NRC)
To regulate all
civilian nuclear
activities
 Five Program Offices:
  o Office of Nuclear
    Material Safety and
    Safeguards
  o Office of Nuclear
    Reactor Regulation
  o Office of Nuclear
    Regulatory Research
    (RES)
  o Office of Standards
    Development
  o Office of Inspection
    and Enforcement
All report to the Execu-
tive Director of NRC
Assigned to
RES
Centralized management
responsibility in
RES.  Centralized
implementation
responsibility in
Department of Energy
(mandated by legis-
lation)

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                                    Table A.  Target Agencies for R&D Program Analysis
    AGENCY
   MISSION
 AGENCY ORGANIZATION
                                                                               R&D PROGRAM CHARACTERISTICS
FUND
CONTROL
IMPLEMENTATION
RESPONSIBILITY
III. Food and Drug
     Administration
     (FDA)
IV. Occupational
   Safety and
   Health Adminis-
   tration (OSHA)
To regulate the
safety of the
Nation's foods,
cosmetics, drugs,
medical devices,
biologies, and
electronic radio-
logical products
To assure that no
worker suffers
diminished health,
reduced function
capacity, or
decreased life
expectancy as a
result of his
work experience.
Six Agency Bureaus:
 o Foods
 o Drugs
 o Veterinary Medicine
 o Radiological Health
 o Biologies
 o Medical Devices
 o Diagnostic Products
   report directly to
   the Commissioner.
   Also reporting
   directly to the Com-
   missioner are the
   National Center for
   Toxicological
   Research (NCTR) and
   the Executive Director
   of Regional Operations
   (EDRO)

OSHA located organiz-
ationally within the
Department of Labor and
has no research capability.
OSHA gets research support
from the National Institute
for Occupational Safety
and Health (NIOSH) which
is a part of the Department
of Health, Education, and
Welfare.
Assigned to
Bureaus and
EDRO
Centralized in
program office labs
Assigned to
NIOSH
Centralized implemen-
tation responsibility
in NIOSH

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TABLE D:   RELATIONSHIPS  AMONG THE PROPOSED RESEARCH  COMMITTEES
                                REGULATORY/
                                OPERATIONAL
                                RESEARCH
                                COMMITTEES
     EXPLORATORY
     RESEARCH
     COMMITTEE
ASSIGNED
MISSION
RESEARCH
COMMITTEE

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Table C:  RELATIONSHIP OF PROPoSR) SYSTEM TO DEFINED PROBLEMS  AND  SOLUTION?
     PROBLEMS
   APPROACH
      SYSTEM
     FEATURES
LACK OF RESEARCH
STRATEGY
PROGRAM CONTEXT
FOR RESEARCH
NATURAL MODULES FOR
RESEARCH PLANNING
INADEQUATE
COMMUNICATIONS
    AND
DECISION-MAKING
MECHANISMS
COMMUNICATIONS AND
PROBLEM SOLVING AT
OPERATIONAL LEVELS
RESEARCH COMMITTEES
INADEQUATE
LONG-TERM
RESEARCH
PROGRAM
PROTECT LONG-TERM
RESEARCH
R&D PLANNING TIED TO
EXPLORATORY RESEARCH
COMMITTEE; AGENCY
SYSTEMS IN DECISION
RULES AND SAFEGUARDS
INSUFFICIENTLY
TIMELY/USEFUL
RESEARCH
FINDINGS
GREATER PROGRAM AND
REGIONAL INFLUENCE
AND RESPONSIBILITY
RESEARCH INCENTIVES
SYSTEM
UNEVEN RESEARCH
QUALITY
MORE QUALITY REVIEW
THROUGHOUT PLANNING
AND MANAGEMENT
PROCESS
PEER REVIEW THROUGH
RESEARCH COMMITTEES

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