STATEMENT OF WORK FOR BIOPHYSICAL RESEARCH AND ANALYSIS
Document Type:
Collection:
Document Number (FOIA) /ESDN (CREST):
CIA-RDP96-00789R003000420013-9
Release Decision:
RIPPUB
Original Classification:
S
Document Page Count:
14
Document Creation Date:
November 4, 2016
Document Release Date:
March 19, 2003
Sequence Number:
13
Case Number:
Publication Date:
July 11, 1991
Content Type:
STATEMENT
File:
Attachment | Size |
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CIA-RDP96-00789R003000420013-9.pdf | 644.77 KB |
Body:
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SECRET
STATEMENT OF WORK
FOR
BIOPHYSICAL RESEARCH AND ANALYSIS
1.0 (S/NF) PURPOSE: The purpose of this effort is to perform
biophysical research and analysis on neuromagnetic phenomena.
2.0 (S/NF) BACKGROUND: The FY 1991 Defense Authorization Act
identified DIA as executive agent of a new program for examining
anomalous phenomena. One of the areas of specific interest was
based on results from an earlier DOD sponsored research effort
involving brain neuromagnetic responses to various visual or
visual-related stimuli. This pilot work was performed by the
Biophysical Group at the Los Alamos National Laboratory (LANL),
Los Alamos, NM, as part of an Army research effort under the
Surgeon General's Research and Development (SGRD) office.
3.0 (S/NF) OBJECTIVE: This statement of work is based on
findings from the previous LANL research on this topic. Primary
objective of this effort is to identify correlations of brain
neuromagnetic responses to a variety of independent conditions or
parameters.
4.0 (S/NF) SCOPE: This activity will replicate previous
results, will recalibrate the experimental environment, will
search for possible artifacts and will initiate new systematic
research. This new research will include a variety of population
groups and will examine a variety of possible physical variables.
All the measurements will be based on passive
magnetoencephalograph (MEG) recording instrumentation.
5.0 (U) TECHNICAL/OTHER CONSIDERATIONS:
5.1 (S/NF) This effort is part of a larger external
investigation effort in this general phenomenological area that
includes a DIA contractor, the Science Applications International
Corporation (SAIC). The SAIC program manager for this effort,
Dr. Ed May, had been directly involved in the previous LANL
activities in this area. Consequently, LANL will be required to
work with both the DIA COTR and the SAIC program manager for most
of the activities identified in this statement of work (SOW).
5.2 (S/NF) It is anticipated that both government and
contractor supplied individuals will be involved in the MEG-
measurement activity. All activity involving non-DIA
CLASSIFIED BY: DIA/DT
DECLASSIFY ON: OADR Enclosure 1
SECRET/NOFORN
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personnel (e.g., contractor supplied) will be coordinated in
advance with the DIA COTR. Specific subject/population types to
be investigated will be reviewed and approved by the COTR well in
advance of their involvement.
5.3 (U) All research protocols, analysis methodologies,
specific scheduling, and other procedures .will be
reviewed/approved by the DIA COTR. A contractor Scientific
Oversight Committee (SOC) will review and comment on all
experimental protocols, procedures and analysis methods. The SOC
will also review and comment on the final report prepared for
this effort.
5.4 (U) This effort will be subject to review by the LANL
Human Use Review Panel to assure that all experiments with human
subjects conform to standard human use guidelines set forth by
Health and Human Service and DOD regulations. (Additional human
use guidance is provided on attachment 1. to this SOW).
5.5 (U) The contractor will be required to submit brief
progress reports and cost data to the DIA COTR on a monthly
basis. A final technical report containing all protocols,
methodology,, analysis techniques, results, and conclusions will
be provided to the COTR by 1 July 1992. An advanced draft of
this final report will also be required 2 weeks prior to
submission of the final report.
5.6 (U) Should unforseen schedule or other issues arise
concerning any of the specific tasks identified in-:section 6.0,
the COTR will be given immediate notice. If necessary,
adjustments to priorities and schedules can be approved by the
COTR if there is no cost or other impact on the overall project.
6.0 (U) SPECIFIC TASKS:
6.1 (U) Examine the hardware and software used in the
earlier remote stimuli study to determine possible instrumental
artifacts; calibrate existing electromagnetic/
magnetoencephalograph (MEG) environment. This should include,
but is not limited to, (a) open sensors; (b) brain equivalent
targets; and (c) non-central nervous system targets.
6.2 (S/NF) Perform new remote stimuli experiments with a
variety of subject population types and variations to the remote
aspect (e.g., vary light stimuli parameters, vary location from
MEG room, presence/absence of "senders").
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6.3 (U) For same subject pool as used in item 6.2, perform
direct visual stimuli measurements under a variety of MEG sensor
locations. Identify correlations to various population groups,
where possible.
6.4 (S/NF) Examine results from item 6.3 to determine
inter-group discrimination potential of MEG results.
7.0 (U) QUICK REACTION CAPABILITY (QRC): The contractor will
maintain quick response capability to problems or unexpected
demands (e.g., briefings, unique subject availability,) as may be
encountered during this project.
8.0 (U) ALLOCATION OF EFFORT: Level of effort to be applied to
each task is shown below:
TASK NO. ALLOCATION OF EFFORT (%)
6.1
15
6.2
60
6.3
20
6.4
5
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HUMAN USE GUIDELINES
A. DEFINITIONS
1. Human Subject: An individual about whom an investigator
conducting research obtains data through interaction with the
individual, including both physical procedures and manipulations
of the subject or the subject's environment. The term does not
include military or civilian personnel who are qualified to test
by assignment to duties that call specifically for such
qualifications such as test pilots and test engineers.
2. Non-U.S. Citizens: Foreign nationals, excluding,
personnel on active duty.
3. Research: The term does not include individual or group
training of military personnel such as combat readiness,
effectiveness, proficiency, or fitness exercises.
B. GENERAL GUIDANCE
1. The contractor shall conduct research using human
subjects at all times so as to be in full compliance with all
applicable laws, federal regulations and DOD instructions. Among
them are:
a. 45 CFR 46 Health and Human Services (HHS)
Regulation, "Protection of Human Subjects";
b. 10 U.S.C. Section 980, "Limitations on Use of
Humans as Experimental Subjects";
c. DOD Directive 3216.2 (January 7, 1983) "Protection
of Human Subjects in DOD-supported Research";
2. Safeguarding the rights and welfare of subjects at risk
in activities supported by this contract is the responsibility of
the Contractor. Compliance with this contract will in no way
render inapplicable pertinent federal, state, or local laws or
regulations. In order to provide for the adequate discharge of
this institutional responsibility, no activity involving human
subjects under this contract shall be undertaken unless a
Contractor Human Use Review Board (CRB) has reviewed and approved
such activity.
3. The contractor must provide the Contracting officer with
a written assurance that it is in compliance with all provisions
of 45 CFR 46 HHS Regulation, "Protection of Human Subjects," as
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Attachment 1 to Enclosure 1
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4. The Contractor will assure the Contracting Officer that
the identities of all subjects will be protected.
5. Informal consent must be obtained in writing from each
human subject before research is undertaken.
6. The contractor shall provide all necessary medical care
to research subjects for injury or disease which is the proximate
result of participation in the research.
7. Studies conducted outside the United States, its
territories or possessions, shall be conducted in compliance with
all laws, customs, and practices of the country in which the
study is to be conducted.
C. REQUIREMENTS FOR REPORTING AND DOCUMENTATION
1. Copies of all documents presented or required for
initial and continuing review of the CRB, e.g., Board minutes
pertaining only to the contract, record of subjects consent,
transmittal on actions, instructions and conditions resulting
from Board deliberations addressed to the activity director, are
to be retained by the Contractor for at least three (3) years
after completion of the research. All documents shall be
accessible for inspection during normal working hours by the DIA
COTR or authorized representative.
2. Except as otherwise provided by law, information in the
records or possession of the Contractor which refers to or can be
identified with a particular subject may not be disclosed except:
a. With the consent of the subject or his legally
authorized representative, or
b. As may be necessary for the DIA to carry out its
legal responsibilities.
3. Upon expiration or termination of this contract, a list
of all unused test material shall be provided to the DIA
Contracting Officer.
4. The Contractor shall immediately notify the DIA
Contracting Officer, by telephone, of inquiries from sources
outside the Department of Defense concerning the use of human
subjects under this contract.
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CONTROL NO.
JUSTIFICATION AND APPROVAL
FOR OTHER THAN FULL AND OPEN COMPETITION
1. (U) Contracting Authority: Virginia Contracting Activity,
P. O. Box 46563, Washington, DC 20050-6563.
2. (U) Authority Cited: 10 U.S.C. 2304(c)(1); FAR 6.302-1,
"Only one responsible source and no other supplies or services
will satisfy Agency requirements."
3. (U) Description of Sup lies/Services: The Defense
Intelligence Agency (DIA) proposes to procure Biophysical
Research and Analysis services for a DIA special evaluation
activity. External assistance funds are available for this
effort, and are part of a Congressional Directed Program.
4. (U) Description of Action: It is anticipated that a cost-
plus-fixed fee contract will be negotiated and awarded to satisfy
this requirement. R&D funds for this effort are cited on
Purchase Request (PR) No. 330/028Z/91.
5. (U) Reason for Authority Cited:
a. (U) This action is based on the need to utilize
research achievements from a previous DOD-sponsored R&D effort.
b. (S/NF) Between 1985-1989, the Army's Surgeon General
Research and Development (SGRD) office sponsored basic research
in a phenomenological evaluation area. One of the specific
topics initiated by this SGRD effort was examination of brain
neuromagnetic activity correlates. This pilot effort was
performed by the Biophysics Group at the Los Alamos National
Laboratory (LANL), Los Alamos, NM, due to their unique equipment
and analysis capability. Investigations from this pilot work
yielded positive results. Follow-on to this work is one of the
main research activities desired in the Congressional direction
as part of DIA's over-all Phenomenological Research Program.
c. (S/NF) This specific effort at LANL was originally
included in PR 330/0012Z/91, via subcontract from the Science
Applications International Corporation (SAIL). However, it has
recently been determined that direct MIPR action from DIA to LANL
would be more appropriate then an SAIC subcontract at this time
for this specific Biophysical Research and Analysis task.
SECRET/NOFORN
1
Classified By: DIA/DT Enclosure 2
Declassify On: OADR
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In addition, Dr. Charles Wood, the Biophysical Group's director,
had over two years of direct involvement in the previous pilot
activity and was responsible for developing all appropriate
methodologies and analysis techniques.
d. (S/NF) This neuromagnetic activity research and
analysis task requires a sole source procurement in order to
efficiently build upon previous pilot study findings and to take
advantage of the LANL interdisciplinary staff and their
expertise. The Biophysics Group had previously developed all
appropriate experimental protocols, analysis techniques,
hardware, and task-specific software required for in-depth study
of neuromagnetic responses as required under this task,
e. (S/NF) While a few medical facilities exist with
similar monitoring systems, none of them have the complex
interdisciplinary or analysis capability required for this topic
of investigation. In addition, none of them are capable of
examining unique parameters or physical variables as required for
DIA's over-all evaluation in this area. It would require 3 'or
more years for another contractor to build up similar expertise.
Consequently, sole source procurement form LANL is the proper
action for accomplishing this sensitive task in a timely and
effective manner.
6. (U) Efforts to Obtain Competition: Due to the uniqueness of
this research area, there are no other qualified research
facilities and personnel available to satisfy this contract. To
bring other potential organizations up to speed would not be
possible without unacceptable delays or additional costs.
7. (U) Action to Increase Competition: Every effort will be
made to release research results as widely as possible to attract
other potential researchers. Not only will this be accomplished
through specialized (and properly classified) channels, but also
appropriate portion will be released at unclassified levels to
attract interest in academic facilities.
8. (U) Market Survey: Based on the significant advantage that
the Los Alamos National Laboratory possesses in this area, a
market survey would not serve a useful purpose at this time.
9. (U) Interested Sources: No other source has expressed an
interest in this requirement.
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SG1J
SG1J
10. (U) Other Factors:
a. (S) Acquisition data availability: Data from previous
government-sponsored research is available in DIA. Since this
was part of a controlled access project, every effort will be
made to downgrade, and where practical, declassify basic aspects
of the research. This will, in time, generate a wider interest
in this field.
b. (U) Unusual and Compelling Urgency: This task requires
timely response form LANL in order to meet the Congressionally-
directed requirements. This requirement can only be satisfied
via other than full and open competition and by utilizing the
existing LANL capabilities.
11. (U) Technical Certification:
I hereby certify that the supporting data under my cognizance
which are included in the J&A are accurate and complete to the
best of my knowledge and belief.
Title
Signature:
12. (U) Requirements Certification:
SG1J
I hereby certify that the supporting data under my cognizance
which are included in the J&A are accurate and complete to the
best of my knowledge and belief.
SG1J
Name : Date : // Zcq q1
13. (U) Fair and Reasonableness Cost/Price Determination: A
detailed technical and cost proposal will be required from the
contractor, LANL. Prior to award, the Government will conduct an
in-depth analysis of all technical and cost aspects of this
requirement. Based on the outcome, a fair and reasonable cost
will be negotiated. Therefore, I hereby determine that the
anticipated cost for this contract action will be fair and
reasonable.
Vice Assistant Deputy Director
Title: for Scientific and Technical Signature:
Intelligence
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14. (U) Contracting Officer Certification:
In accordance with FAR 6.303-2 (a) (12), I hereby certify that
the facts and representation under my cognizance, which are
included in this J&A, are accurate and complete to the best of my
knowledge and belief.
NAME:
Contracting Officer
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Based on the foregoing justification, I hereby approve the
procurement of BIOPHYSICAL RESEARCH AND ANALYSIS on an other than
full and open competition basis pursuant to the authority of 10
U.S.C. 2304(c) , subject to availability of funds, and
provided that the services and/or property herein described have
otherwise been authorized for acquisition.
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RESEARCH OF PLANNED, ON-GOING,
AND COMPLETED STUDIES
Research by my staff indicates,' to the best of our knowledge,
that there is no other known similar or collateral study or
analysis, planned, in progress, or completed which fulfills the
objectives or specific intent of this proposed contract study:
Biophysical Research and Analysis (Purchase Request #
330/028Z/91) .
Date: (b ~F-otk ci/
AND COMPLETE:
Date: It _ Tv~ 0 ~( J
Assistant Deputy Director
for Scientific and
Technical Intelligence
JOHN T. BERBRICH-,
SG1J
SG1J
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1. Funds cited may be used only for the project delineated in
the classified Statement of Work (Enclosure 1).
2. The DIA estimate for this project is $250,000.00 over a 12
month period.
3. The total MIPR estimate shall not be exceeded by the
purchasing office.
4. Changes in purpose, scope or desired results from those
delineated in the Statement of Work must have DIA approval.
A copy of the final Statement of Work will be provided to
DIA/DT-S for review prior to further contractual actions.
5. The MIPR should be addressed to: HQ DOE
Attn: Barbara Moyers, IN-40
Forrestal) Bid
Washington, D.C. 20585
6. Two copies of the final contract should be provided to:
Defense Intelligence Agency
ATTN: VP-SF
Washington, D.C. 20340
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H rovea r
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1. .e of request
PQR
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-- Delivery required by
e request number
VV=V
PURCHASE REQUEST
11 Jul 91
30 Sep 92
330/028Z/91
INSTRUCTIONS - ORIGINAL AND 8 COPIES
4A. DIAM 442) 5A. Funds are certified available and have been committed
Accounting classification 58. Amount
R/D: 9710400.44 7M1 6FO301 1222 503744 $250,000.00
JOHN T. BERBRICFr7A sst Dep Dir for S&T
Type Name Date
4B. Name, Ext, and Signature of Designated Supply Coordinator
(DIAM 25-1) 6C. Name and signature of Certifying Official
Signature Signature SG 1 A
SG 1 J
Type Name Date Type Name onto
Office Symbol
IjIiTT
SGJ
Washington, D.C. 20340-6150 (DT-5A)
BA
E
stimated
Stock/item No.
Description of Supplies or Services
Quantity
Unit
Price
Amount
RELEASE OF FUNDS FOR EXTERNAL RESEARCH
$250,000.00
AND ANALYSIS.
Sole Source Contract with Los Alamos
National Laboratory (LANL), for
biophysical research and analysis.
9. El Recurring requirement Source:
86. Total
GSA Schedule Number (if known) _
$250,000.00
Acquisition Plan No.
Action Office if External to DIA: HQ DOE/LANL Omer: Barbara Movers
10
.
HQ DOE/IN/40 (202) 586-8297
Interservice Support Agreement No: External POC:
11. Justification/Remarks
The purpose of this request is to conduct biophysical research via the Los Alamos
National Laboratory (LANL), Los Alamos, NM. Funds for this effort are in the
approved FY 91 DIA budget as line item 1.004 for Congressional Directed Programs.
12A. Requisition Number/Other
13A. Coord'ndt~ s ^CRRB ^SADPO
" la
GC OC-4
VP-SF
12 B Logistics Branch Action Officer/Phone No.
OC-5 TS-6B
R _ ,B RSQ
Date
Method
12C
13B. Approvals Not required
13C. Budget Reporting Code
.
(DIAR 44-4)
R400
E3 Contracting and Acquisition Office
CRRB
E3 Yes ^ No
El Other:
SADPO
12D. Received By: (Signature)
14A. Action Assigned To:
14B. Date
Contract Specialist:
le ne No:
;~
Previ edition is Obsolete.
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WHEN SEPARATED FROM
~
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15. OBLIGATION R
ECORD
AMOUNT OF COMMITMENT
$
DATE
REFERENCE
NUMBER
OBLIGATIONS
INCURRED
UNOBLIGATED
BALANCE
REMARKS
DATE
REFERENCE
NUMBER
OBLIGATIONS
INCURRED
UNOBLIGATED
BALANCE
REMARKS
)W Std?f~4 f a aX~l4d(c 4d(l;~A( i( ~f t s~(
X X Ix*A0XW)WFh (Vh) ftWX:X
RECAP: Basic . . . . . . . . . . . . . . $250,000.00
Uniform Contract Format (over $25K)
1 Statement of Work/Specifications
2 SYril'evur2Sewstification for other than full and open competition
SADPO Acquisition Authority
Emergency Justification
Services Questionnaire
List of Recommended Sources
DTIC/NTIS Statement (R&D)
Economic Analysis/Cost Comparison Analysis (DIAR 45-8) $50K+
DD 254, Security Classification Specification
DD 1423, Contract Data Requirements List with Data Item Description (DD Form 1684)
Technical Evaluation Criteria
Technical Evaluation Plan
Logistical Support Plan (DIAR 25-4)
3 Other( 2
4 MIP Q14Aar1FA-RDP96-007898003000420013-9