CIA-RDP96-00789R003000390002-5

Approved For Release 2000/08/08 : CIA-RDP96-00789R003000390002-5
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UNIFORM CONTRACT FORMAT
PART I - THE SCHEDULE
SECTION B - SUPPLIES/SERVICES AND PRICES
B.1 SERVICES AND PRICES
LINE ITEM DESCRIPTION
QUANTITY
AMOUNT
0001
External RDT&E in accordance with
1 Lot
$1,500,000
specifications set forth in Section C.
(Subsections 6.1 through 6.4) .
0001a
External Research and Analysis in
accordance with specifications set
forth in Section C (subsection 6.5).
1 Lot
200,000
0002
Reports
7
1
NSP
0002AA
Workplan Milestone Report
1
NSP
0002AB
Progress Reports
10 (est)
NSP
0002AC
Special Report
1
NSP
0002AD
Final Technical Report
1
NSP
000ZAE
Variance Report
As needed
0002AF
Technical Briefing
1
NSP
0003
Quick Reaction Capability
As needed
-
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Enclosure 2
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PART I - THE SCHEDULE
SECTION C -- DESCRIPTION/SPECIFICATIONS
C.1. WORK STATEMENT: Under this contract, the contractor, as an
independent contractor, and not as an agent, servant, or employee of the
Government, utilizing special knowledge and techniques possessed by and
available to the contractor, shall furnish all Jabor, equipment, facilities,
services, and materials, necessary for the performance of the work set forth
below: See Statement of Work, Enclosure 3, and DD Form 1423 (Contract Data
Requirements List) dated 26 Jan 89 attached in Exhibit A.
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PART I - THE SCHEDULE
SECTION F - DELIVERIES OR PERFORMANCE
F.1 TIME OF DELIVERY:
The work and services required under Section B shall
be completed/delivered as specified on Enclosure 9.
F.2.
TERM OF CONTRACT:
F.2.1. The work required by task 6.1 through 6.4.2 shall be performed
during the period commencing on the effective date of this contract and not
to exceed 18 months in length.
F.2.2. The work required by task 6.5 shall be performed during the
period commencing on the effective date of this contract and ending 30
September 1991.
F.3. PLACE OF PERFORMANCE:
The work under this contract shall be performed
at the contractor's facilities unless otherwise provided in this contract.
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PART I - THE SCHEDULE
SECTION H - SPECIAL PROVISIONS
H. 1.
DISCLOSURE OF INFORMATION:
a.
The contractor shall not disclose any information under this contract,
including the following, to any person unless (i) it is required for the
performance of this contract or (ii) the individual is specifically
authorized in writing by the Contracting Officer to receive the information.
(1 )
The contract schedule and technical data incorporated therein.
.
(2)
Sponsorship of the contract.
(3)
The Government's use, interest in, or application of the
following:
(a)
The contract schedule and technical data incorporated
therein.
(b)
Purchase description, specifications and drawings.
(c)
Scientific studies, research, development and design service.
(d)
Components, devices, equipments and systems.
(e)
Techniques, methods and processes.
(f )
Details and/or results of performance.
b.
Disclosure by the contractor which require specific written
authorization from the Contracting Officer include information, whether
written or oral, to be revealed in open publications, technical conferences,
symposia, meetings, periodicals, journals, brochures, advertising, films,
photographs, fact-sheets, or other material prepared for open publication.
c. When prescribed by the Contracting Officer, the contractor agrees to
insert in subcontracts and purchase order hereunder provisions which shall
conform substantially to paragraphs a and b. Normally these provisions will
not be required by the Contracting Officer in purchase orders for standard
commercial items which have been sold or offered for sale to the public
commercially by any supplier.
d.
The provisions set forth in paragraphs a, b, and c shall not be
construed to preclude the contractor from otherwise using, for its normal
commercial purposes, information, techniques, processes, methods,
developments, components, devices, equipments, systems, and proprietary data
employed in the conduct of the work, except that which is specifically
developed for or as a result of this contract, or which is precluded from
release due to its classified nature. In so using the information as
authorized by this paragraph the contractor (i) shall not disclose any
information concerning the sponsorship of this contract, or
(ii) the nature of the Government's interest in and application of the
subject matter of this contract.
e. The contractor will submit to the Contracting Officer for clearance and
release six (6) copies of the material at least four (4) weeks in advance of
presentation or publication.
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H.2. GOVERNMENT FURNISHED DATA: The Contractor shall request any data
required for the conduct of this contract, in writing, from the Contracting
Officer's Technical Representative (COTR). The COTR will maintain records
of all such Government furnished data to insure accountability and return to
the Government upon termination of the contract.
H. 3.
SECURITY REQUIREMENTS:
a. The Contractor shall maintain and administer a security program in
accordance with DoD 5220.22-M Industrial Security Manual and DIAM 50-5.
Copies of these documents are available for review in the office of the
procuring Contracting Officer.
b. Loss or suspension of required security clearance, as set forth on the
.
attached DD Form 254 (Contract Security Classification Specification) will
result in inability to perform in accordance with the terms and conditions
of the contract. As a result the contract is subject to default in
accordance with the clause entitled "Default. "
C. The Government reserves the right to direct any Contractor employee to
be removed from performance, direct or indirect, whenever there is probable
cause to believe, on the basis of all facts available, that such action is
warranted in the interest of national security, whether or not the cause is
deemed of sufficient severity to warrant action to terminate the
Contractor's or individual's security clearance.
The Government also
reserves the right to direct any contractor employee to be removed from
performance, direct or indirect, for the period of time necessary to conduct
any investigation of alleged misconduct which may, in the opinion of the
Contracting Officer, jeopardize the security of the project.
d. Military security requirements in the performance of this contract shall
be maintained in accordance with the DD Form 254 contained in Section J.
The highest classification involved in the performance of this contract is
Top Secret/Special Compartmented Intelligence (SCI). This contract document
is unclassified.
e. The contractor will not use any electronic/electrical information
processing equipment in the possession of the Contractor for the purpose of
processing or transmitting classified information under this contract
without the written permission of the Contracting Officer.
H.4. CHANGE IN KEY PERSONNEL: The Contractor shall notify the Contracting
Officer prior to making any change in the personnel identified in the
proposal as key personnel assigned to this contract. The Contractor must
demonstrate that the qualifications of the prospective personnel are equal
to or better than the qualifications of the personnel being replaced.
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H.5. USE OF HUMAN SUBJECTS:
a.
Definitions
1.
Subject at Risk - means any individual who may be exposed to the
possibility of injury, including physical, psychological or social injury,
as a consequence of participation as a subject in any research, development
or related activity which departs from the application of those established
and accepted methods necessary to meet his needs, or which increases the
ordinary risk of daily life, including the recognized risks inherent in a
chosen occupation or field of service.
2. Investigational Drugs - means those new drugs restricted by the
Federal Food, Drug and Cosmetic Act to be used by or under the supervision
of an investigator pursuant to a notice of Claimed Investigational Exemption
for the New Drug (IND).
3.
Investigational Medical Devices - means those devices which are not
generally recognized as safe and/or effective, intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of disease in, or
research on, humans where the research is usually (but not necessarily) for
the purpose of determining whether or not the device is safe and/or
effective.
b.
Requirements for the Use of Humans
1. Safeguarding the rights and welfare of subjects at risk in
activities supported by this contract is primarily 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
. Esponsibility, it is the policy of the DIA that 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.
2. The contractor shall provide to DIA a written assurance that it will
abide by the policy for the protection of human subjects as contained in
title 45, Part 46, of the Code of Federal Regulations (CFR), as amended.
When the contractor has a Health and Human Services (HHS) approved
assurance, evidence of CRB approval of this study shall have been
accomplished by submission to DIA of an executed HHS form 596. For a
contractor without an HHS approved assurance, an assurance concerning the
protection of human subjects shall have been negotiated with the DIA COTR,
and CRB approval given.
(Note:
the CRB activity is referred to in the CFR
as an Institutional Review Board (IRB) activity. )
3. In addition to the requirements of Title 45, Part 46 of the CFR, the
following shall apply to all DIA contracts supporting research, development,
and related activities:
a)
Prisoners of war (POW) and detainees shall not be used under any
circumstances.
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b) Use of prisoners as research subjects shall have been
specifically approved by the DIA Contracting Officer.
c)
A mentally disabled or institutionalized mentally infirm person
shall not participate as a research subject unless the nature of the
research involved is such that it would be impossible or meaningless if
mentally infirm were restricted from participation, or other considerations
are involved. Specific approval for their use shall have been granted by
the Contracting Officer. The research must be concerned with:
(i) The diagnosis, treatment, prevention, or etiology of the
particular impairment with which the subject is afflicted, or
(ii) Any other condition from which the subject is suffering,
providing there is a direct potential benefit to the subject and adequate
prior testing has been accomplished to give assurance of acceptable risk, or
(iii)
The effects of institutional life upon the
institutionalized mentally infirm subject, and involves no appreciable risk
to the subject, or
(i.v)
Information which cannot be obtained from any other class of
subject.
d)
Volunteers and/or research subjects, either contractor,
consultant, or subcontractor, shall be the responsibility of the contractor
who shall provide all necessary medical care for injury or disease that is
the proximate result of taking part in the contract research.
e) New people entering this project for training purposes, or for
participation as subjects of research, shall sign a statement that they will
not use information attained during the course of participation to invade
the privacy of US citizens.
f )
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 the Use of Investigational Drugs
Investigational drugs of any kind shall not be used for this contract.
d. Requirements for Use of Investigational Medical Devices
The Contractor shall comply with Title 21, Part 812, of the CFR, as amended,
for the study and evaluation of those devices which are not generally
recognized as safe and/or effective intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in, or research on, humans.
The contractor shall have to provide with his proposal a copy of FDA
approval of, or grant of waiver for, use of investigational device
exemption.
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e.
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 outside the Department of Defense concerning the
use of human subjects under this contract. In addition, the Contracting
Officer shall be notified as soon as possible of inspections of the facility
or contract protocols by the FDA.
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