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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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ORA Research Process - Pilot Study

Subject:
ORA Research Process - Pilot Study
Area:
Operations Management
Date Revised:
July, 30 1998

 

 

PURPOSE

To provide guidance on the development, submission and review of ORA methods development and technology transfer. To assure all proposals are of the highest quality and meet regulatory needs, evaluate the accomplishments of approved projects, and support the validation and eventual use of successful methods.

BACKGROUND

While enhancing the creative skills of talented individuals in ORA Laboratories, this ORA program is designed to satisfy the need for regulatory analytical methods meeting current and anticipated public health program needs and agency priorities.

ORA's research goals are:

Provide opportunity, including partnerships, for ORA scientists to develop analytical methodologies, technologies and related scientific initiatives that support the regulatory and public health protection mission of FDA.

Enhance the ability of ORA staff to transfer the products of our research to day to day operations.

To achieve these goals ORA management must:

Be supportive of practical research that meets current and anticipated Agency needs in the context of ORA's mission in FDA.

Be sensitive to improving the overall quality of research proposals so that management can properly assess the significance, probability of success and ultimate value of this research.

Be able to explain the tangible and intangible benefits of ORA's research accomplishments and defend our process.

Strengthen and support the critical role of Science Advisors in the implementation and execution of research.

RESPONSIBILITIES

Associate Commissioner for Regulatory Affairs (ACRA)

The ACRA is the final approval authority for Science Advisors Research Associate Program (SARAP) proposals and providing funding for the execution of the program.

Office of Regional Operations (ORO)

The Director ORO is the final approval authority for research recommended for approval by the Research Technology Transfer Committee (RTTC) and Division of Field Science (DFS) and the recommending official to the ACRA for approval of SARAP proposals. The Director ORO shares responsibility for promoting and supporting a strong ORA research program, determining ORA research goals.

DFS

Manages research from the headquarters perspective. The Division participates in all meetings and deliberations of the RTTC, coordinates the research approval process, and develops and implements research guidelines and rating and ranking criteria. DFS issues the call for research needs and proposals and distributes information to the RTTC members. The Division monitors research progress and, with the RTTC, assesses research goals and the impact of these accomplishments.

DFS may direct research to meet emerging or immediate needs that arise outside the normal review process. The DFS Program Managers coordinate collaborations and method validation by communicating Center and other criteria for validation.

Field Managers are responsible for:

The timely planning, execution and accomplishment of research projects.

Recognizing scientists who successfully complete research projects commensurate with the level of contribution to the regulatory mission of ORA and FDA.

District Directors and Directors of Science are responsible for:

Final review and approval of research proposals before submission to the RTTC.

Directors of Science, or Science Branch Directors, are responsible for:

Reviewing and evaluating proposals.

Assuring completeness within the guidance of this FMD.

Assuring proposals contain all of the necessary signatures.

Establishing a priority listing of the proposals.

Reviewing progress reports.

Signing the final report and impact statement indicating review and endorsement.

Assuring that approved research is implemented and accomplished in a timely manner.

ORA Analysts are responsible for:

Submitting any identified research needs in response to DFS' call.

Developing and submitting research proposals in accordance with approved procedures.

Timely accomplishment of approved research projects.

Adhering to the highest standards of intellectual honesty and ethical standards in formulating, conducting and presenting research.

Science Advisors are responsible for:

Providing training and working with analysts to develop research proposals, assuring all guidelines and directives are met, assisting in the conduct of research and evaluating the results.

Making recommendations to the ORO, DFS and RTTC for improving ORA research.

Providing guidance in the preparation of publications.

Research Technology Transfer Committee (RTTC)

Positions on the RTTC are held for 3-5 years. Replacements are recommended by the Committee Chair with concurrence by the Director, ORO.

Together with DFS, the RTTC is responsible for:

Issuing the annual call for research needs to the Centers and the field, and identifying and addressing research issues.

Preparing, with input from the Centers, a Research Planning Document (RPD) of identified research needs with the call for research proposals.

Reviewing, rating, ranking and recommending research proposals with input from the Centers.

Providing feedback to researchers regarding their proposals.

Recommending modifications to directives, guidelines and criteria for the conduct of research.

Participating with DFS in implementing approved research.

Monitoring research progress to determine the extent to which research goals and objectives are met, making recommendations for collaboration and/or validation of developed methods or new technologies, making recommendations to the Centers and Field Program Committees for inclusion in compliance programs, and measuring the impact of accomplished research projects.

Participating in the resolution of conflicts and problems in the ORA research process.

 

Identification of Research Needs

On or about, October 1, a call will issue to the Centers and field to identify research needs (RTNs) for the following fiscal year. The format for submitting a need is included. [Attachment A]

A need may be simply stated as: "There is a need for a rapid microbiological method to detect Vibrio vulnificus in raw shellfish." Or be more general as in: "There is a need for rapid microbiological methods." The identified need is supported by statements describing mission relevance and regulatory significance. These needs should be submitted to DFS in WP (Version 5.1 or 6.0) or in WORD 97 format on a 3 1/2" diskette along with one hard copy. Each RTN should be saved as a separate file and must be submitted by November 1.

Evaluation of Needs and Preparation of Research Planning Document

Following the receipt of research needs from the field and Centers, representatives of DFS and the RTTC will evaluate them, with input from the Centers, to determine which to include in the Research Planning Document (RPD).

Call for Research Proposals

On December 1, the RPD will issue to the field along with the call for research proposals. An "information only" copy of the call will be sent to the Centers. Research proposals, regulatory lab and SARAP, are to be submitted using the most current 1609 form [Attachment B] following the prescribed requirements. Proposals must address needs identified in the RPD to be considered for approval by the RTTC unless substantial justification regarding a new need is provided. The 1609 submission will identify which need the proposal addresses. Proposals must be for at least 250 hours.

Local management evaluates the proposals using the appropriate rating form [Attachments C or D], completes a check list [Attachment E] to assure that all criteria for submission of the proposal are met and sets the local priority for the proposals being submitted. When determining how many proposals to submit, management must be guided by the amount of research they can reasonably support. Submission of a research proposal is a commitment on the part of management to support and accomplish the research project, if it is approved.

Research proposals are due to DFS on March 1.

When Center contacts are identified in the RPD, then the Analysts must contact the representative(s) for additional guidance and focus. This contact must be indicated in the 1609 submission.

Only complete proposal packages will be reviewed by the RTTC. They must include:

Form 1609 with all sections complete, including signatures.

Evaluation Form.

Proposal Checklist.

Narrative evaluation by the Science Advisor.

A memo ranking the proposals in priority order signed by the Science Branch Director.

Research proposals (regulatory lab and SARAP) should also be sent to DFS in WordPerfect (Version 5.1, 6.0) or WORD97 format on a 3 1/2" diskette along with one hard copy containing the appropriate signatures.

Research Review and Approval Process

The RTTC will meet in mid-May to rate and rank research proposals for the following fiscal year using the appropriate approval criteria [Attachment C or D]. Each Center participates in the process by reviewing the proposals, making recommendations to the RTTC and assisting in the planning and implementation of projects. For projects submitted for continuation, management should include input on the analyst's progress report to the RTTC.

Feedback from the RTTC to the researchers will be provided following the May meeting. For some proposals, DFS may request additional information or rewrites prior to approval.

ORA Technical Plan

The ORA Technical Plan, which is the approved research for the following fiscal year, will be published by September 1, (e.g., the FY 99 ORA Technical Plan would be published by September 1, 1998).

Required Reports

Progress reports will include a summary of:

Work accomplished to date.

Discussion of problems or findings.

Redirection of work indicated by findings if warranted.

NOTE: For continuation projects: to enable the RTTC to consider all progress on a current year project when reviewing a continuation project, significant findings should be E-mailed to the DFS Research Team by May 1.

Research progress reports (1609a) [Attachment F] will be submitted to DFS on an annual basis. The 1609a has been revised and includes specific areas that need to be addressed, such as: Abstract, Introduction, Materials and Methods, Results and Discussions, Conclusions and Publications. It is essential that the Science Advisor participate in preparation of the 1609a and include an in-depth narrative evaluation. The 1609a must be signed by the researcher(s), Science Advisor, immediate supervisor and local management.

A minimum of an LIB is expected for all 1609 and SARAP research projects.

Final reports for approved projects of up to 500 hours are due to DFS on April 1 and for projects greater than 500 hours on October 1 via one hard copy and 3 1/2" Diskette WP 5.1 or 6.0 or WORD 97 format. Exception to the completion date may be granted by DFS when satisfactory justification is submitted with a request for an extension.

Final reports must include an Impact Form [Attachment H]. This form should briefly identify the objectives, outcomes and impact of the project. The brief statement on the outcomes should include important information gained from the research, and if successful, the outcome statement should include specific improvements in the method(s) or new knowledge gained. The statement should also include appropriateness for collaboration or validation, changes to official methods or standards, incorporation into a compliance program, etc. Subsequent outcomes of the project can be submitted to DFS at any time for incorporation into the next Impact Report.

ORA Research Accomplishments

When all final research reports have been received, DFS will perform a review and prepare an annual report of both achievements and areas of concern for review and concurrence by the Director, DFS, and the Chair of the RTTC. The purpose of this report is to provide both ORA and the Centers with a progress review to assist in preparing the next Research Planning Document and to apprise management of accomplished versus planned research.

DFS will prepare periodic follow-up reports of research to include regulatory impact, publications, presentations, collaborative studies, adoption as Official methods (adoption by other field and headquarters laboratories), inclusion in compliance programs, etc.

A time table summary is included [Attachment G]. ORA milestones are included along with suggestions as to certain local milestones and activities that may be accomplished.

Attachments:

A - RTN Form (Research Needs)
B - 1609 Form (Proposal Form)
C - 1609 Evaluation Factors
D - SARAP Evaluation Criteria
E - 1609 Proposal Checklist
F - 1609a Progress Report
G - Research Timetable
H - Impact Form

Attachment A

 

FISCAL YEAR  1999
RESEARCH TECHNOLOGY TRANSFER NEEDS
(FORMERLY RESEARCH NEEDS IDENTIFICATION FORM)

RTT NEED:

 

Mission Relevance:

 

Regulatory Significance of Problem:

 

Key Words:
Name:
Location:
Contact Phone #:

To Be Completed By DFS

PPS Code:
Center:
Center Contact:
Contact Phone #:

RTN Priority:
RTN #:

(Form: RTN 7/98)

 

Research Need:

Must be consistent with ORA Research Goals (See FMD - 143). The clearer the connection between the research need and the regulatory and public health protection mission of FDA the greater the opportunity for consideration of the research. For example: "There is a need for a rapid microbiological method to detect Vibrio vulnificus in raw shellfish" or more general such as: "There is a need for rapid microbiological methods".

Mission Relevance:

These statements tie the research need to specific or general program responsibilities of FDA. For example: Traditional analytical methodology for pathogens consumes significant resources and time. Availability of rapid methods would expedite identifying pathogens in regulated products.

Regulatory Significance of the Problem:

These statements describe the surveillance and enforcement advantages to the agency that would come from this research. For example: Research constraints are requiring us to find more efficient and effective means to isolate and identify pathogens. Imported products, epidemiological consideration, and the need to have scientifically credible data to take enforcement actions and inform the public, drive the need for these rapid methods.

Key Words:

No more than five words/combinations that capture the essence of the proposal, e.g. Rapid Microbiology Methods, Pathogens, and Vibrio vulnificus.

Priority: The Center(s) with program responsibility and the RTTC will determine this. This will be used during the evaluation of Factors A, C and D of the Regulatory Lab Research Project Evaluation and Scientific Merit Score and Applicability of the SARAP Evaluation Criteria.

Instructions for Submitting:

Submit printed hard copy in WP (Version 5.1 or 6.0) or WORD 97 format on 3 1/2" diskette.

 

Attachment B

ORA RESEARCH PROPOSAL
Division of Field Science, Office of Regulatory Affairs
U.S. Food and Drug Administration

1. RESEARCH PROJECT NO. ______________________    2.   LABORATORY _________________

3. FISCAL YEAR _______________________________    3a. RESOURCES HOURS _____________ 

4. PPS NO. ___________________________________    4a. RTN NUMBER   ________________

5. TITLE   ________________________________________________________________________

6.  NAME (S), POSITION CLASS, AND CONTACT PHONE NUMBER OF SCIENTIST

6a. SIGNED   ______________________________________  DATE  ________________________

7.  TYPE OF RESEARCH

    __________ Regulatory Lab Project
    __________ SARAP
    __________ Research Center Project

8. ABSTRACT

 

9. MILESTONES                                          QUARTER
                                                                         1st             2nd           3rd           4th

 

Tie the experimental approach to specific milestones and activities that will be accomplished.

a.

b.                                                                                                                                                                                     

c.                                                                                                                                                                                     

d.                                                                                                                                                                                     

e.                                                                                                                                                                                      

f.                                                                                                                                                                                       

10. DECLARATION OF LOCAL FUNDING SUPPORT (applicable only to Regulatory Lab Projects and Research Center Projects

                                                                                                                                         
Signature of Science Branch Director/Research Director/Director of Science/District Director/ or other appropriate management official.

 

                                                                                                                                                            
NAME/SIGNATURE OF SCIENCE ADVISOR/RESEARCH DIRECTOR               (DATE)
                                                                                                                                                           
NAME/SIGNATURE OF SUPERVISOR                                                                       (DATE)
                                                                                                                                                          
NAME/SIGNATURE OF APPROVING OFFICIAL                                                      (DATE)

 

FORM FDA 1609 (7/98)

 

Attachment B (contd)

 

INSTRUCTIONS FOR COMPLETING FORM FDA 1609
ORA Research Proposal

GENERAL

Prepare this form when a research project is being proposed to solve a regulatory problem. This form will be submitted both as a hard copy and electronic record. For the additional required information, please identify continuation pages by proposal title and number in the upper right hand corner of each page, and also indicate 'page of pages' in lower right-hand corner.

SPECIFIC ITEMS

1. PROJECT NUMBER:    To be assigned by the Division of Field Science when project is finally approved. For District Discretionary Projects, contact DFS for a number.

2. LABORATORY:    Enter name and mailing symbol.

3. FISCAL YEAR:    Enter the fiscal year.

3a. RESOURCES-HOURS:     Enter estimated requested hours.

4. PPS/RTN:    Enter Program Project System and Research needs numbers.

5. TITLE:    Enter a concise descriptive title that contains the key words that might be used for publication and indexing.

6. SCIENTIST (S):    Type name, Position Class, Contact Phone Number and sign. 6a. SIGNED DATE

7. TYPE OF RESEARCH:     Indicate type of research time requested.

8. ABSTRACT:    (Describe the regulatory significance, the work that is proposed and the goals to be achieved. Limit the abstract to the space provided. Additional required information; i.e. Introduction, Experimental Approach, Literature Review and Science Advisor/Research Center Director Review should be provided as components of a comprehensive research proposal.) Provide a 200-400-word summary of the reasons for proposing the research project together with a general description of the experimental approach, the anticipated goals, and their relationship to the regulatory issue. In addition to this abstract the analyst is expected to furnish the following items as attachments in support of the project:

Introduction:     Provide a narrative discussion of the regulatory problem and a review of current scientific knowledge in this area with appropriate literature references and supporting statements.

Experimental Approach:     Provide detailed descriptive information on how you expect to solve the stated regulatory problem.

Expected Improvements:     Explain how your project will help solve regulatory problem and justify the time requested.

Literature Review:     List all major references with title and authors that relate to the stated problem and are referenced in the narrative text.

Funding Required:     Indicate the funds required to implement the proposal.

Review/Evaluation by Science Advisor or Research Center Director:    The Science Advisor/Research Director is expected to review the project and provide an in-depth evaluation concerning the scientific merit of the probability of success using the experimental approach in the proposal.

9. MILESTONES:     Tie the experimental approach to specific milestones and activities that will be accomplished.

10. DECLARATION OF FUNDING SUPPORT:     In the case of Regulatory Lab Research Projects and Research Center Projects, local management is expected to indicate intention to fund the project should approval be given to proceed.

11. SIGNATURES/ENDORSEMENTS:     Signatures should be provided to indicate that the proposal has been reviewed for submission and consideration for approval to DFS.

Attachment C

 

OFFICE OF REGULATORY AFFAIRS
DIVISION OF FIELD SCIENCE AND
RESEARCH TECHNOLOGY TRANSFER COMMITTEE
RESEARCH PROJECT EVALUATION

 

PROJECT TITLE:                                                                                                                                                               
                                                                                                                                                                                             

PPS:                                              RTN#:                                                                                                                            

HOURS:                                  PRIORITY:              HIGH            MEDIUM          LOW       

EVALUATION FACTORS

FACTOR

POINTS

SCORE

COMMENTS

A. IMPORTANCE OF THE PROBLEM
(Mission Relevance and
Regulatory Significance)

0-30

   

B. EFFECTIVENESS OF APPROACH
(Assess the Logic Behind
the Scientific Soundness
of the Experimental Design)

0-25

   

C. EFFECT ON QUALITY OF RESULTS
(Enhances Regulatory
Credibility/Science)

0-20

   

D. EFFECT ON PRODUCTIVITY
(Relates to Probability
of Enhancing Enforcement
Capabilities)

0-15

   

E. PROBABILITY OF SUCCESS
(Mix of Researcher
Capability and
Technological Innovation)

0-10

   

TOTAL SCORE

0-100

   

 

The evaluation of Factors A, C and D should correlate with the RTN priority established by the Center(s) with program responsibility and the RTTC. Scores of 30, 20 and 15, respectively should only be given to proposals, which address RTNs with a high priority. Proposals, which address RTNs with a medium priority, should not score above 25, 15 and 10, respectively.

Revised 7/98

 

ATTACHMENT D

PROJECT TITLE:                                                                                                                                                                        

PPS/RTN                                PRIORITY:             HIGH             MEDIUM           LOW                                                                 

 

HOURS:                                  

 

SARAP EVALUATION CRITERIA

CRITERIA

POINTS(WT)

SCORE

COMMENTS

SCIENTIFIC MERIT SCORE
Are the objectives of the
Proposal realistic and
Scientifically sound?

1-10(25)

   

APPLICABILITY
Are the stated objectives
Important to FDA?

1-10(25)

   

TIME FRAME
Can this work be reasonably
Accomplished in the time
Proposed?

1-10(5)

   

LITERATURE BACKGROUND
Has an adequate current
Literature search been done
in the development of the
proposal?

1-10(10)

   

BUDGET
Is the proposed budget
Adequate to accomplish the
Stated objectives in a
Rational and effective
Manner, making optimum use
of available equipment and
facilities?

1-10(5)

 

 

INDIVIDUAL DEVELOPMENT
Will the project lead to the
Personal development of
Scientific skills and
Knowledge of value to the
Participant?

1-10(15)

   

EDUCATION/TRAINING
Is educational component
Appropriate and adequate?

 

1-10(15)

   

TOTAL SCORE

0-1000

   

 

The evaluation of Scientific Merit and Applicability should correlate with the RTN priority established by the Center(s) with program responsibility and the RTTC.

(Form: SARAP 7/98)

Attachment E
Research Proposal Checklist

Proposal Title:                                                                                                                                                                                                              

Full Names of Analyst(s):                                                                                                                                                                                           
with Position Class and Telephone Number:                                                                                                                                                          
(Chemist, Microbiologist, etc.)

PPS Code:

1)             Problem and purpose are specifically defined. The regulatory significance is fully described.

2)              Goals and objectives are clear. Agency significance is defined: High, Medium, Low.

3)              Literature search has been conducted and is complete. The background and literature support the approach to the research project.                   References are tied into text of the proposal.

4)            Research approach (Hypothesis) and preliminary results support going forward with further research.

5)            Analyst(s) have training/expertise required or specific training required for project is planned.

6)             Research coincides with laboratory specialization.

7)              Equipment and reagents required are available.

8)              Experimental design and timetable with projected milestones has been completed.

9)              References (Full Citations) are attached.

10)           Budget breakdown for research project is listed. Full costs are estimated, excluding salaries.

11)           Request for IACUC approval has been initiated (If ANY Animal Work Is Included).

12)           Appropriate signatures for ALL levels of review have been obtained.

13)            Previous research accomplishments have been listed.

(Revised 7/98)

Attachment F

 

RESEARCH RECORD FINAL REPORT

1. RESEARCH PROJECT NO. :                                                                                 2. LABORATORY:                                    

3. FISCAL YEAR :                                              3a. RESOURCES -- HOURS:                                         

4. PPS NO.:                                                        4a. RTN Number:                                                          

5. TITLE:                                                                                                                                                                                         

6. NAME (S), POSITION CLASS, AND CONTACT PHONE # OF SCIENTIST:

6a. SIGNED:                                                                                              DATE :                    

7. TYPE OF RESEARCH                                                      8. HOURS

               Regulatory Lab Project                                         PLANNED THIS FISCAL YEAR                                    
               SARAP                                                                    USED THIS REPORT PERIOD                               
               Research Center Project                                        USED THIS FISCAL YEAR                                   
                                                                                                  USED TO DATE                                                       

9.WORK ACCOMPLISHED AND/OR PLANNED (Abstract, Introduction, Materials & Methods, Results & Discussion, Conclusions & Publications)

 

 

10. MILESTONES                                                            QUARTER
                                                                                             1st           2nd           3rd             4th

Tie the experimental approach to specific milestones and activities that will be accomplished.

a.                                                                                                                                                                                              

b.                                                                                                                                                                                              

c.                                                                                                                                                                                              

d.                                                                                                                                                                                             

e.                                                                                                                                                                                              

f.                                                                                                                                                                                               

11. COMMENTS (Science Advisor or Research Center Director)

 

                                                                                                                                                                     
NAME/SIGNATURE OF SCIENCE ADVISOR/RESEARCH DIRECTOR      (DATE)
                                                                                                                                                                     
NAME/SIGNATURE/TITLE OF SUPERVISOR                                                (DATE)
                                                                                                                                                                     
NAME/SIGNATURE/TITLE OF APPROVING OFFICIAL                             (DATE)

FORM FDA 1609a  (Revised 7/98)

Attachment F (contd)

 

INSTRUCTIONS FOR COMPLETING FORM FDA 1609a
ORA Research Record

GENERAL

Prepare this form when a research project's progress is being described or as a final report. This form will be submitted both as a hard copy and electronic form. For the additional required information, please identify continuation pages by title and number in the upper right hand corner of each page, and also indicate 'page of pages' in lower right-hand corner.

SPECIFIC ITEMS

1.   PROJECT NUMBER:    Enter the number assigned by the Division of Field Science

2.   LABORATORY:    Enter name and mailing symbol.

3.   REPORT PERIOD

4.   PPS/RTN:   Enter Program Project System and Research Needs Numbers.

5.   TITLE:   Enter a concise descriptive title that contains the key words that might be used for publication and indexing.

6.   SCIENTIST (S):    Type name, Position Class, Contact Phone Number and sign.

6a.  SIGNED DATED

7.   TYPE OF RESEARCH:    Indicate type of research time requested.

8.   HOURS PLANNED/USED

9.   WORK ACCOMPLISHED:

Abstract: The abstract should not exceed 150 words. It should summarize the basic contents of the report. The abstract should state clearly the objective(s) of the study and if they were met, a concise description of the experiment(s), major observations, results and conclusions. The Abstract should not contain references, tables or diagrams. Remember the Abstract will be the most widely read portion of the paper hence, it should be prepared with great care. In addition to the Abstract, the analyst is expected to furnish the following items as attachments.

Introduction: The introduction should state the rationale for the investigation and its relationship to FDA's agency mission. It should also provide sufficient background information, including references, to support the scientific soundness of the reported study. If the manuscript describes a new method, reasons should be given why it is preferable to the older methods.

Materials and Methods: This section should provide sufficient information so that a researcher can repeat the experiments that are described in the paper. It should include appropriate apparatus, reagents, procedures, equipment, etc. used. Published procedures should be cited but not described, except where there are substantial modifications. Sources of reagents and equipment (company, city, state) should be identified. Names that are Trademarks should be so indicated (e.g. Styrofoam). Special safety considerations and precautions should be identified.

Results and Discussion: The results should be presented in tables or figures where possible. The discussion should be concise and deal directly with the interpretation of the results. Point out the significant findings and relate the new information to advances in technology. Tables and figures must be numbered in the order mentioned in the text. Tables and figures should have appropriate legends and data should be identified properly. The discussion should cite any problems and future planned work if applicable.

Conclusions and Publications: The conclusions should site how the research achieved the intended mission relevance and regulatory significance of the issue as articulated in the Research Needs Identification Form and 1609 proposal. Include any prepared publications and/or indicate plans for stating or reporting the research findings.

10. MILESTONES: Tie the experimental approach to specific milestones and activities that were accomplished.

11. COMMENTS: The Science Advisor or Research Center Director is expected to review the project and provide in-depth evaluation concerning the scientific merit of the research.

12. SIGNATURES/ENDORSEMENTS: Provided to indicate that the report has been reviewed and concurred with for submission to DFS.

 

Attachment G

 

ORA RESEARCH TIME TABLE SUMMARY

 

Item ORA Milestones Local Milestones
 
1. Call to Centers and ORA for Research Technology Transfer Needs Oct.1  
  • Solicit local research needs
  ++
  • Local management/Science Advisor review and evaluate needs
  ++
  • Submit most viable proposed needs
  ++
2.  Research Needs with Justifications from Centers and ORA Due to DFS

Nov. 1

 
3.  RTTC and DFS (with Centers' input) Generate Research Planning Document (RPD).  Issues to Field Labs with Call for 1609 and SARAP Research Proposals. Dec. 1  
  • Conduct Technical Writing refresher course of Research Proposal development Course
  ++
  • Solicit and evaluate abstracts for proposal development by local management and Science Advisors
  ++
  • Prepare proposals, rate and rank locally
  ++
  • Prepare ongoing research progress reports
  ++
4.  Research Proposals Due to DFS March 1  
5.  Final Reports for up to 500 Hour Projects Due to DFS April 1  
  • publich accomplishments
  ++
  • present accomplishments local/other peers
  ++
  • assess need for continuation of project, modifications, collaborative study, etc.
  ++
6.  Rating and Ranking of Proposals by RTTC May 15  
7.  Fiscal Year Technical Plan Published Sept. 1  
  • incorporate into local workplan
 

++

8.  Final Reports for >500 Hour Projects Due to DFS Oct. 1  
9.  Begin the Research Planning Process for the next fiscal year. Oct. 1  
10.  Annual ORA Research Summary Report of Accomplishments and Concerns. Dec. 1  

 

 

++ Suggested Local Activities

Attachment H

 

ORA RESEARCH IMPACT FORM

                                                                                                                           PPS:                      
Research Project Number/Title of Research Project                                  LAB/RC:                                          

RPN:                                :

OBJECTIVE OF RESEARCH PROJECT:
(Describe what your research project proposed to do in 25 words or less)

 

OUTCOME (S) RESULTING FROM RESEARCH PROJECT:
(Describe the "outcome(s)" of your research in 50 words or less)

 

WHAT IS THE IMPACT OF THESE RESEARCH/WHO IT AFFECTS?

(Describe the "impact(s)" of your research - be brief but complete)

 

 

SUMMARY:

   

__________  Ready for Collaboration/Validation Hours Approved: _________
__________  Collaborative Study Started/Done Hours Used:  ____________
__________  New Method  
__________  Modified Method Project Approved for Continuation? ___________
__________  Manuals Updated/Changed (If yes, RPN#) __________
__________  Publications  
__________  LIB issued  
__________  Presentations Further Continuation Request Anticipated?  ___________
__________  Other (__________)  
 
 
                                                                                                                                                                                                                                    
Signature of Science Branch Director/Director of Science                                   Signature of Science Advisor

Revised 7/98

 

Instructions for Completing the Impact Form

FORMAT:        (No More Than One Page - each project must be on a separate page)
                            Attach Impact Form to the top of 1609a End of Year Progress Report

GENERAL INSTRUCTIONS:

PPS (upper right corner): fill in the appropriate program code (s) "03-99"
LAB/RC (upper right corner): fill in all participating laboratories/research centers
RPN/Title of Research Project: fill in the assigned Research Project Number and Title

 

OBJECTIVE: Describe what the research project objectives are (be brief -  25 words or less should be suficient)
OUTCOME (S): Describe the "outcomes" of the project (see below - be brief - 50 words or less are sufficient) should include success or failure.  For successful projects include critical information such as limits, percent recovery, sensitivity, etc.
IMPACT (S): Describe the "impacts" of the project (see below - be specific in describing what "impact" has been obtained and who is affected by it - industry, consumer, scientific community, etc.)  This should include appropriateness for collaboration/validation, incorporation in a compliance program, change to manuals or standards, etc.
SUMMARY: Designed to help capture the "impact" information into a database - check the items that apply, fill in where information is needed (hours/other/etc.)

SOME "OUTCOMES"

- development/modification of methods/rapid methods

- development of efficient and cost effective cleanup procedures

- development of analytical methodology to compile data for risk assessment studies

- utilization of emerging technology (more sensitivity/better detection limits)

- improved methods/stronger enforcement/improved detection limits

SOME "IMPACTS"

- policy decisions based on sound scientific evidence to reduce public health risk

- improved efficiency/effectiveness of the agency's compliance programs

- ability to determine and enforce standards of identity (NLEA)

- analytical capability for new chemicals use/new categories of compounds for analysis

- conservation of agency resources (handle sample load more efficiently with less cost)

- decreased cost of hazardous waste disposal/reduced use of chemical solvents

- more effective risk assessment studies/better understanding of organisms

- Technology Transfer (manuals/LIBs/Publications/Presentations/field use of methods/etc.)