Contract No. N01-HB-87144
DETAILED TABLE OF CONTRACT CONTENTS
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PART I - THE SCHEDULE
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SECTION A - SOLICITATION/CONTRACT FORM................................1
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SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS.....................4
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ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES.......4
ARTICLE B.2. ESTIMATED COST AND FIXED FEE....................4
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS...........4
ARTICLE B.4. ADVANCE UNDERSTANDINGS..........................5
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT.................6
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ARTICLE C.1. STATEMENT OF WORK...............................6
ARTICLE C.2. REPORTING REQUIREMENTS..........................8
SECTION D - PACKAGING, MARKING AND SHIPPING...........................9
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SECTION E - INSPECTION AND ACCEPTANCE.................................9
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SECTION F - DELIVERIES OR PERFORMANCE.................................9
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ARTICLE F.1. DELIVERIES......................................9
ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE..............10
SECTION G - CONTRACT ADMINISTRATION DATA.............................11
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ARTICLE G.1. PROJECT OFFICER................................11
ARTICLE G.2. KEY PERSONNEL..................................11
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING
REQUEST AND CONTRACT FINANCIAL REPORT..........11
ARTICLE G.4. CONTRACT FINANCIAL REPORT......................12
ARTICLE G.5. INDIRECT COST RATES............................12
ARTICLE G.6. GOVERNMENT PROPERTY............................12
ARTICLE G.7. POST AWARD EVALUATION OF PAST PERFORMANCE......13
SECTION H - SPECIAL CONTRACT REQUIREMENTS............................13
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ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT
RESEARCH AND DEVELOPMENT PROJECTS..............13
ARTICLE H.2. HUMAN SUBJECTS.................................14
ARTICLE H.3. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO
RESEARCH.......................................14
ARTICLE H.4. NEEDLE EXCHANGE................................14
ARTICLE H.5. SALARY RATE LIMITATION LEGISLATION PROVISIONS..14
ARTICLE H.6. PUBLICATION AND PUBLICITY......................15
ARTICLE H.7. PRESS RELEASES.................................15
ARTICLE H.8. REPORTING MATTERS INVOLVING FRAUD,
WASTE AND ABUSE................................15
PART II
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SECTION I - CONTRACT CLAUSES.........................................16
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ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT
RESEARCH AND DEVELOPMENT CONTRACT..............16
ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES.............19
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES....................19
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Contract No. N01-HB-87144
PART III
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SECTION J - LIST OF ATTACHMENTS......................................20
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1. Invoice/Financing Request Instructions for NIH
Cost-Reimbursement Type Contracts.........................20
2. Financial Report of Individual Project/Contract...........20
3. Instructions for Completing form NIH 2706, Financial
Report of Individual Project/Contract.....................20
4. Safety and Health.........................................20
5. Procurement of Certain Equipment, NIH(RC)-7...............20
6. Contractor-Acquired Government Property - Schedule I-B....20
7. Property Acquired Under Predecessor Contract -
Schedule II-A.............................................20
PART IV
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SECTION K - REPRESENTATIONS AND CERTIFICATIONS.......................21
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Representations and Certifications...........................21
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Contract No. N01-HB-87144
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
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ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
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The objectives of this project are to maintain a repository of blood specimens
from NHLBI-sponsored studies and to make appropriate specimens available to the
scientific community for use in research related to transfusion-transmitted
diseased and a variety of other disorders of blood or the cardiovascular
system.
ARTICLE B.2. ESTIMATED COST AND FIXED FEE
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a. The estimated cost of this contract is $__________.
b. The fixed fee for this contract is $________. The fixed fee shall be
paid in installments based on the percentage of completion of work, as
determined by the Contracting Officer, and subject to the withholding
provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE
referenced in the General Clause Listing in Part II, ARTICLE I.1. of
this contract. Payment of fixed fee shall not be made in less than
monthly increments.
c. The Government's obligation, represented by the sum of the estimated
cost plus fixed fee, is $2,901,590.
d. Total funds currently available for payment and allotted to this
contract are $377,835, of which $356,448 represents the estimated
costs, and of which $21,387 represents the fixed fee. For further
provisions on funding, see the LIMITATION OF FUNDS clause referenced in
Part II, ARTICLE I.2. Authorized Substitutions of Clauses.
e. It is estimated that the amount currently allotted will cover
performance of the contract through June 14, 1999.
f. The Contracting Officer may allot additional funds to the contract
without the concurrence of the Contractor.
g. Future increments to be allotted to this contract are estimated as
follows:
Period Amount
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June 15, 1999 through June 14, 2000 $ 461,262
June 15, 2000 through June 14, 2001 481,974
June 15, 2001 through June 14, 2002 503,693
June 15, 2002 through June 14, 2003 526,469
June 15, 2003 through June 14, 2004 550,357
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
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a. Items Unallowable Unless Otherwise Provided
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Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT and FIXED FEE,
incorporated in this contract, unless authorized in writing by the
Contracting Officer, the costs of the following items or activities
shall be unallowable as direct costs:
(1) Acquisition, by purchase or lease, of any interest in real
property;
(2) Special rearrangement or alteration of facilities;
(3) Purchase or lease of any item of general purpose office
furniture or office equipment regardless of dollar value.
(General purpose equipment is defined as any items of personal
property which are usable for purposes other than research,
such as office equipment and furnishings, pocket calculators,
etc.);
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Contract No. N01-HB-87144
(4) Travel to attend general scientific meetings;
(5) Foreign travel;
(6) Patient care costs;
(7) Accountable Government property (defined as both real and
personal property with an acquisition cost of $1,000 or more
and a life expectancy of more than two years) and "sensitive
items" (defined and listed in the Contractor's Guide for
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Control of Government Property), 1990, regardless of
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acquisition value.
ARTICLE B.4. ADVANCE UNDERSTANDINGS
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Other provisions of this contract notwithstanding, approval of the following
items within the limits set forth is hereby granted without further
authorization from the Contracting Officer.
a. Consultants
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Consultant fees to be paid to the following individuals:
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b. Repository Relocation
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A transition phase (June 15, 1998 through December 15, 1998) is
provided for relocation of the NHLBI biological specimen repository
from McKesson BioServices, 685 Loftstrand Lane, Rockville, Maryland
20850 to the repository facility operated by BBI-Biotech Research
Laboratories, Inc., 217 Perry Parkway, Gaithersburg, Maryland. The
Contractor shall complete interior fit out of the NHLBI repository
space, located at 217 Perry Parkway, Gaithersburg, Maryland, so as to
allow for a safe and orderly transition of the NHLBI biological
specimen repository from McKesson BioServices to the new location. The
Contractor shall transfer all Government-owned NHLBI freezers,
biological specimens, files, and inventory records, on or before
December 15, 1998. Repository relocation costs shall not exceed
$23,932.
c. Confidential Treatment of Sensitive Information
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The Contractor shall guarantee strict confidentiality of the
information/data that it is provided by the Government during the
performance of the contract. The Government has determined that the
information/data that the Contractor will be provided during the
performance of the contract is of a sensitive nature and cannot be
disclosed in any manner.
Disclosure of the information/data, in whole or in part, by the
Contractor can only be made after the Contractor receives prior written
approval from the Contracting Officer. Whenever the Contractor is
uncertain with regard to the proper handling of information/data under
the contract, the Contractor shall obtain a written determination from
the Contracting Officer.
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
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Contract No. N01-HB-87144
ARTICLE C.1. STATEMENT OF WORK
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a. Independently and not as an agent of the Government, the Contractor
shall furnish all the necessary services, qualified personnel,
material, equipment, and facilities, not otherwise provided by the
Government as needed to perform the Statement of Work below:
PHASE I - Transition
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The contractor shall coordinate an orderly and safe transition from the current
incumbent contractor site to the new location, including the transport of
stored specimens, data, and all Government-furnished property. Contractor
shall adhere to the moving plan previously approved by the Department of
Transportation (DOT). This approval allows for the exemption from the
requirements of 46 CFR Part 64 regarding Federal hazardous material
transportation law so that specimens shall be moved in the freezers in which
they are stored.
Relocation of the NHLBI repository from McKesson BioServices, 685 Lofstrand
Lane, Rockville, MD 20850 to the Contractor's facility at 217 Perry Parkway,
Gaithersburg, Maryland 20877 shall be completed before December 15, 1998. At
the time of repository relocation, it is estimated that 2.8 million specimens
will be stored in 98 freezers and 5 liquid nitrogen tanks.
PHASE II Repository Maintenance
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Task 1 - Maintain Serum, Plasma, and Cell Repository
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The contractor shall provide facilities and equipment to receive, store,
aliquot, and distribute potentially hazardous biologics such as serum, plasma,
and cells from individuals infected with AIDS virus and hepatitis viruses. The
facilities must provide aseptic and/or sterile conditions as appropriate
(Biosafety Level 2 Containment). The specimens shall be maintained by the
contractor in freezers at temperatures between -70 degrees and -80 degrees
centigrade. Freezers shall be located in an air-conditioned facility with
temperatures maintained between 20 degrees and 25 degrees centigrade (60
degrees to 77 degrees F) when freezers are in operation. The contractor shall
supply uninterruptible power to accommodate the refrigerators/freezers and
other equipment. Freezers shall be connected to a central alarm system
monitored twenty-four hours per day. The contractor shall provide an automated
temperature monitoring system composed of individual temperature probes
monitored 24 hours a day and controlled by a master computer, and a plan to
ensure that necessary personnel are notified in the event of freezer
malfunction. Emergency standby freezers shall be available in case of
mechanical failure of any portion of storage space. In addition, alternative
emergency freezer cooling systems such as a liquid nitrogen system or dry ice
must be available. The contractor must have backup electric generators capable
of operating all storage equipment for at least 48 hours in the event of
utility company power failure. Backup generators must be tested monthly. Cell
specimens (or tissues) shall be maintained at liquid nitrogen gas phase, in
special liquid nitrogen chests.
In order to accommodate the estimated increase of the number of specimens/vials
contained in the repository and the replacement of obsolete freezers, the
contractor shall purchase approximately six freezers per year, using contract
funds. The estimated increase in vials will result from the splitting of
specimens and arrival of new specimens.
Task 2 - Preparing Aliquots from Selected Specimens *
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The contractor shall provide laboratory facilities and personnel for dividing
the serum or plasma samples into aliquots. All requests for samples are
reviewed by the NHLBI. Once an original specimen is identified for
distribution, it is thawed
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Contract No. N01-HB-87144
and divided into aliquots, one of which is sent to the investigator, and the
remaining aliquots refrozen for later use. It is estimated that approximately
1,000 specimens shall be divided into 10,000 aliquots annually.
Thus, the size of the repository increases regularly as original specimens are
divided and distributed and new specimens are added to the repository. The
handling of all biological specimens and Government-owned property under this
contract shall be in accordance with all applicable local, state, and federal
regulations. In addition, in order to provide safety controls for protection to
the life and health of employees and other persons, the contractor shall
consult, comply with, and include in all applicable subcontracts, the following
standards, as appropriate:
1) Biosafety in Microbiological and Biomedical Laboratories, U.S.
Department of Health and Human Services, Centers for Disease Control
(CDC) and the NIH, DHHS Pub. No. (CDC) 93-8395.
2) Occupational Safety and Health Administration (OSHA), Publication 29
CFR Part 1910.1030, Occupational Exposure to Blood Borne Pathogens,
Final Rule.
Task 3 -Prepare and Ship Panels of Aliquots or Specimens *
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The Project Officer receives and reviews requests from investigators for
specimens or panels of aliquots. When a request is approved, the NHLBI Project
Officer will design panels of aliquots or specimens on the basis of the
investigator's experimental needs. On the basis of that design, the Project
Officer will provide to the contractor the information needed to prepare and
ship each panel. It is estimated that preparation and shipment of
approximately 50 panels, containing 100 vials each, will be required annually.
A list identifying the specimens to be included in a panel will be provided to
the contractor.
The contractor shall prepare the panels as required by the Project Officer.
Shipments will require preparation of the panel, packing the panel in dry ice,
packaging the panel in insulated boxes, and express shipment (usually by air)
to the final destination (specifically, the approved investigator). The
contractor shall ship all vials C.O.D.; transportation and postage costs are to
be paid by the recipients from point of carrier receipt. The contractor shall
verify receipt of the panel by the investigator both in writing and by phone.
Packaging and shipment shall meet standards for biologically hazardous
materials (see publication prepared by the International Air Transport
Association (IATA), Dangerous Goods Regulations, current edition).
Task 4 - Add Specimens to the Repository *
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The contractor shall inventory, prepare for storage, package, and label, as
necessary, specimens to be added to the repository. The project officer will
specify the dates of arrival of such specimens, the number of specimens, and
the means of packaging, labeling and storing these samples as well as the type,
number and location of freezers to be relocated to the contractor's site. It
is essential that shipments be coordinated by the contractor so that personnel
will be available to receive the arriving packages and transport shipment to
the NHLBI repository for storage at the required temperature.
Task 5 - Performance of Virologic and Serologic Assays *
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The contractor shall provide the capability to perform (in-house or through a
subcontractor) serologic and virologic assays for the evaluation and validation
of candidate blood screening tests for the detection of transfusion-associated
agents. For this purpose, laboratory biosafety level 2 shall be required, as
well as laboratory personnel with specific training in handling pathogenic
agents.
Laboratory personnel, safety practices, and techniques shall be supplemented by
appropriate facility design and engineering features, safety equipment, and
management practices. The contractor shall ensure that persons working with
these infectious agents are aware of potential hazards and strictly adhere to
standard microbiological practices and techniques. Costs for these assays will
be negotiated and the contract amount increased as the need arises.
The human pathogens for which blood screening tests are being developed or
improved and, therefore, are likely to be involved in future assay evaluation
and validation procedures, include hepatitis viruses, human retroviruses, and
agents of
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Contract No. N01-HB-87144
transmissible spongiform encephalopathies. Among the serologic and virologic
test formats that the contractor is expected to perform are enzyme
immunoassays, polymerase chain reactions, immunoblotting, and in situ
hybridization. It is expected that 500 - 1,000 assays will be required per
year.
Task 6 - Inventory Control
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The contractor shall update and maintain a computerized inventory control data
base using a desktop personal computer system to track and assist in the
coordination of the activities under this contract. At the time of contract
award, the FoxPro data base will contain information on approximately 2.1
million specimens. This will provide inventory and management information to
reflect activities of the repository, i.e., location of specimens, aliquoting
of specimens, preparation of panels, and addition of new specimens. In
addition, the SAS/Repository Management System (RMS) inventory and management
data base shall reflect activities on approximately 700,000 specimens including
location of specimens, aliquoting of specimens, preparation of panels, addition
of new specimens, and results of assays performed by outside investigators
using NHLBI specimens. The SAS software and license shall be provided to the
contractor by the Government.
Task 7 - Ensure an Orderly Transition of the NHLBI Biological Specimen
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Repository to a Successor Contractor
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In the event there is a recompetition of the subject contract and an
organization other than the incumbent is selected for contract award, incumbent
shall assist in ensuring an orderly and safe transition of the repository from
the current location at (address of repository at time of relocation) to any
successor of this contract. This shall include providing repository access to
the new contractor at mutually agreed upon times.
* SPECIAL TRAINING REQUIREMENTS:
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Repository personnel involved in tasks 2, 3, 4, and 5 shall have
specific training in handling pathogenic agents and dealing with
potential hazards of the pathogens likely to be involved in the
operation of the repository.
ARTICLE C.2. REPORTING REQUIREMENTS
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a. Technical Reports
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In addition to those reports required by the other terms of this
contract, the Contractor shall prepare and submit the following reports
in the manner stated below and in accordance with ARTICLE F.1.
DELIVERIES of this contract:
The Contractor shall submit to the Contracting Officer and to the
Project Officer technical progress reports covering the work
accomplished during each reporting period. These reports are subject
to technical inspection and requests for clarification by the Project
Officer. These shall be brief and factual and prepared in accordance
with the following format:
1. Quarterly Progress Report: This report shall include
descriptive information on activities in the repository during
the reporting period. The reporting period consists of the
first full three months of performance plus any fractional part
of the initial month. The first report shall be due September
30, 1998. Thereafter, the reporting period shall consist of
three full calendar months. This report shall include the
following:
a. the number of vials stored on the first and last days
of the reporting period;
b. the number of vials prepared during the reporting
period;
c. a list of panels prepared and shipped during the
reporting period including, for each panel:
1) number of specimens (vials),
2) date of shipment,
3) date of receipt of shipment, and
4) problems with any shipment;
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Contract No. N01-HB-87144
d. maintenance problems encountered and corrective actions
taken;
e. needs for replacement or repair of government-furnished
equipment; and
2. Final Report: Cumulative information for period of performance
of all information included in quarterly progress reports.
SECTION D - PACKAGING, MARKING AND SHIPPING
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All deliverables required under this contract shall be packaged, marked, and
shipped in accordance with Government specifications. The Contractor shall
guarantee that all required materials shall be delivered in immediate usable
and acceptable condition.
SECTION E - INSPECTION AND ACCEPTANCE
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a. The Contracting Officer or the duly authorized representative will
perform inspection and acceptance of materials and services to be
provided.
b. For the purpose of this ARTICLE the Project Officer is the authorized
representative of the Contracting Officer.
c. Inspection and acceptance will be performed at:
Division of Blood Diseases & Resources
National Heart, Lung, & Blood Institute
6701 Rockledge Drive, MSC 7950, Room 10146
Bethesda, MD 20892-7950
Acceptance may be presumed unless otherwise indicated in writing by the
Contracting Officer or the duly authorized representative within 30
days of receipt.
d. This contract incorporates the following clause by reference, with the
same force and effect as if it were given in full text. Upon request,
the Contracting Officer will make its full text available.
FAR Clause No. 52.246-5, INSPECTION OF SERVICES-COST REIMBURSEMENT
(APRIL 1984).
SECTION F - DELIVERIES OR PERFORMANCE
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ARTICLE F.1. DELIVERIES
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a. Satisfactory performance of this contract shall be deemed to occur upon
delivery and acceptance by the Contracting Officer, or the duly
authorized representative, of the following items in accordance with
the stated delivery schedule.
b. The items specified below as described in SECTION C, ARTICLE C.1 and
ARTICLE C.2. shall be made f.o.b. destination as set forth in FAR
52.247-35, F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984)
and in accordance with and by the dates specified below:
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Contract No. N01-HB-87144
Item Description Quantity Delivery Schedule
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1. Quarterly 2 copies to the Project Quarterly during
Progress Officer (PO), period of
Report 1 copy to the Contracting performance
Officer (CO)
2. Final 2 copies to the Project On or before
Report Officer (PO) expiration of
1 copy to the Contracting contract
Officer (CO)
3. All stored biological To be determined On or before
specimens, data files, expiration of
computerized listings of contract
accurate and updated
information on inventory,
data bases, original
data, and any necessary
information related
thereto
Copies of reports shall be sent to the following addresses:
Project Officer - 2 copies AND Contracting Officer - 1 copy
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Blood Resources Program BDR Contracts Section
Division of Blood Diseases & Resources Contracts Operations Branch
National Heart, Lung, & Blood Institute National Heart, Lung, & Blood Institute
6701 Rockledge Drive, MSC 7950, Room 10146 6701 Rockledge Drive, MSC 7902, Room 6140
Bethesda, MD 20892-7950 Bethesda, MD 20892-7902
Federal Express and Couriers: Federal Express and Couriers:
6701 Rockledge Drive 6701 Rockledge Drive
Rockledge 2, 10th Floor, Room 10146 Rockledge Two, 6th Floor, Room 6140
Bethesda, MD 20817 Bethesda, MD 20817
ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)
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This contract incorporates the following clause by reference, with the same
force and effect as if it were given in full text. Upon request, the
Contracting Officer will make its full text available. Also, the full text of
a clause may be accessed electronically at this address:
http://www.arnet.gov/far/.
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
52.242-15, Stop Work Order (AUGUST 1989) with ALTERNATE I (APRIL 1984).
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Contract No. N01-HB-87144
SECTION G - CONTRACT ADMINISTRATION DATA
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ARTICLE G.1. PROJECT OFFICER
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The following Project Officer will represent the Government for the purpose of
this contract:
Luiz H. Barbosa, D.V.M.
The Project Officer is responsible for: (1) monitoring the Contractor's
technical progress, including the surveillance and assessment of performance
and recommending to the Contracting Officer changes in requirements; (2)
interpreting the Statement of Work and any other technical performance
requirements; (3) performing technical evaluation as required; (4) performing
technical inspections and acceptances required by this contract; and (5)
assisting in the resolution of technical problems encountered during
performance.
The Contracting Officer is the only person with authority to act as agent of
the Government under this contract. Only the Contracting Officer has authority
to: (1) direct or negotiate any changes in the Statement of Work; (2) modify or
extend the period of performance; (3) change the delivery schedule; (4)
authorize reimbursement to the Contractor any costs incurred during the
performance of this contract; or (5) otherwise change any terms and conditions
of this contract.
The Government may unilaterally change its Project Officer designation.
ARTICLE G.2. KEY PERSONNEL
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Pursuant to the Key Personnel clause incorporated in this contract, the
following individual is considered to be essential to the work being performed
hereunder:
NAME TITLE
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Mark Cosentino, Ph.D. Principal Investigator
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST
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a. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type
Contracts NIH(RC)-1 are attached and made part of this contract. The
instructions and the following directions for the submission of
invoices/financing request must be followed to meet the requirements of
a "proper" payment request pursuant to FAR 32.9.
These instructions also provide for the submission of financial and
personnel reporting required by HHSAR 342.7002.
(1) Invoices/financing requests shall be submitted as follows:
An original and two copies to the following designated billing
office:
Contracting Officer
BDR Contracts Section, Contracts Operations Branch
National Heart, Lung, and Blood Institute, NIH
RKL2, Room 6140
6701 ROCKLEDGE DRIVE, MSC 7902
BETHESDA MD 20892-7902
(2) Inquiries regarding payment of invoices should be directed to
the designated billing office, (301) 435-0359.
b. The Contractor shall include the following certification on every
invoice for reimbursable costs incurred with Fiscal
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Contract No. N01-HB-87144
Year funds subject to the salary rate limitation provisions as specified in
ARTICLE H.5. of this contract. For billing purposes, certified invoices are
required for the billing period during which the applicable Fiscal Year funds
were initially charged through the final billing period utilizing the
applicable Fiscal Year funds:
"I hereby certify that the salaries charged in this invoice are in
compliance with P.L. [cite the applicable Public Law Number for the
applicable Fiscal Year as stated in ARTICLE H.5.] and ARTICLE H.5. of
the above referenced contract."
ARTICLE G.4 . CONTRACT FINANCIAL REPORT
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a. Financial reports on the attached Form NIH 2706, Financial Report of
Individual Project/Contract, shall be submitted by the Contractor in
accordance with the Instructions for Completing Form NIH 2706, which
accompany the form, in an original and two copies, not later than the
30th working day after the close of the reporting period. The line
entries for subdivisions of work and elements of cost (expenditure
categories) which shall be reported within the total contract are
listed in paragraph e., below. Subsequent changes and/or additions in
the line entries shall be made in writing.
b. Unless otherwise stated in that part of the Instructions for Completing
Form NIH 2706, entitled "PREPARATION INSTRUCTIONS," all columns A
through J, shall be completed for each report submitted.
c. The first financial report shall cover the period consisting of the
FIRST FULL THREE CALENDAR MONTHS following the date of the contract, in
addition to any fractional part of the initial month. Thereafter,
reports will be on a quarterly basis.
d. The Contracting Officer may require the Contractor to submit detailed
support for costs contained in one or more interim financial reports.
This clause does not supersede the record retention requirements in FAR
Part 4.7.
e. The listing of expenditure categories to be reported is incorporated
within the Financial Report of Individual Project/Contract, NIH 2706,
SECTION J, ATTACHMENT 2, attached hereto and made a part of this
contract.
f. The Government may unilaterally revise the NIH 2706 to reflect the
allotment of additional funds.
ARTICLE G.5. INDIRECT COST RATES
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In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1)
Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in
this contract in Part II, Section I, the cognizant Contracting Officer
responsible for negotiating provisional and/or final indirect cost rates is
identified as follows:
Division of Financial Advisory Services
Office of Contract Management
National Institutes of Health
6100 EXECUTIVE BLVD ROOM 6B05
BETHESDA MD 20892
These rates are hereby incorporated without further action of the Contracting
Officer.
ARTICLE G.6 . GOVERNMENT PROPERTY
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a. In addition to the requirements of the clause, GOVERNMENT PROPERTY,
incorporated in Section I of this contract, the Contractor shall comply
with the provisions of DHHS Publication, Contractor's Guide for Control
of Government Property, (1990), which is incorporated into this
contract by reference. Among other issues, this publication provides a
summary of the Contractor's responsibilities regarding purchasing
authorizations and inventory and reporting requirements under the
contract. A copy of this publication is available upon request to the
Contract Property
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Contract No. N01-HB-87144
Administrator.
This contract's Contract Property Administrator is:
Marea Petrelles
Contracts Property Administrator
Research Contracts Property Administration, NIH
6011 Executive Blvd., Room 641E
ROCKVILLE MD 20852-7670
(301) 496-6466
b. Contractor-Acquired Government Property - Schedule I-B
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Pursuant to the Clause, GOVERNMENT PROPERTY, incorporated in this
contract, the Contractor shall be authorized to acquire the property
listed in Schedule I-B for use in direct performance of the contract,
following receipt of the Contracting Officer's written approval, based
on contractor-furnished prices and evidence of competition.
c. Property Acquired Under Predecessor Contract - Schedule II-A
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Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this
contract, the Contractor shall be authorized, at the time of relocation
of the NHLBI Biological Specimen Repository , to obtain custody of all
Government Property listed in the attached Schedule II-A for use in
direct performance of this contract. Accountability for the items
listed in Schedule II-A shall be transferred, at the time of relocation
of the NHLBI Biological Specimen Repository, to this contract from the
predecessor Contract No. N01-HB017087, under which these items were
provided by the Government. Title to this property shall remain in the
Government.
ARTICLE G.7. POST AWARD EVALUATION OF PAST PERFORMANCE
- -------------------------------------------------------
Interim and final evaluations of contractor performance will be prepared on
this contract in accordance with FAR 42.15. The final performance evaluation
will be prepared at the time of completion of work.
Interim and final evaluations will be provided to the Contractor as soon as
practicable after completion of the evaluation. The Contractor will be
permitted thirty days to review the document and to submit additional
information or a rebutting statement. Any disagreement between the parties
regarding an evaluation will be referred to an individual one level above the
Contracting Officer, whose decision will be final.
Copies of the evaluations, contractor responses, and review comments, if any,
will be retained as part of the contract file, and may be used to support
future award decisions.
SECTION H - SPECIAL CONTRACT REQUIREMENTS
- -----------------------------------------
ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT
- -----------------------------------------------------------------------------
PROJECTS
--------
The primary purpose of the Public Health Service (PHS) is to support and
advance independent research within the scientific community. This support is
provided in the form of contracts and grants totaling approximately 7 billion
dollars annually. PHS has established effective, time tested and well
recognized procedures for stimulating and supporting this independent research
--------
by selecting from multitudes of applications those research projects most
worthy of support within the constraints of its appropriations. The
reimbursement through the indirect cost mechanism of independent research and
development costs not incidental to product improvement would circumvent this
competitive process.
To ensure that all research and development projects receive similar and equal
consideration, all organizations may compete for direct funding of independent
research and development projects they consider worthy of support by submitting
those
12
Contract No. N01-HB-87144
projects to the appropriate Public Health Service grant office for review.
Since these projects may be submitted for direct funding, the Contractor agrees
that no costs for any independent research and development project, including
all applicable indirect costs, will be claimed under this contract.
ARTICLE H.2 . HUMAN SUBJECTS
- -----------------------------
It is hereby understood and agreed that research involving human subjects shall
not be conducted under this contract, and that no material developed, modified,
or delivered by or to the Government under this contract, or any subsequent
modification of such material, will be used by the Contractor or made available
by the Contractor for use by anyone other than the Government, for experimental
or therapeutic use involving humans without the prior written approval of the
Contracting Officer.
ARTICLE H.3. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
- ---------------------------------------------------------------
Section 513 of the Fiscal Year 1998 Appropriations Act (P.L. 105-78) prohibits
NIH from using appropriated funds to support human embryo research. Contract
funds may not be used for (1) the creation of a human embryo or embryos for
research purposes; or (2) research in which a human embryo or embryos are
destroyed, discarded, or knowingly subjected to risk of injury or death greater
than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2)
and Section 498(b) of the Public Health Service Act (42 U.S.C . 289g(b)). The
term "human embryo or embryos" includes any organism, not protected as a human
subject under 45 CFR 46 as of the date of the Act, that are derived by
fertilization, parthenogenesis, cloning, or any other means from one or more
human gametes or human diploid cells.
Additionally, in accordance with a March 4, 1997 Presidential Memorandum,
Federal funds may not be used for cloning of human beings.
ARTICLE H.4. NEEDLE EXCHANGE
- -----------------------------
Pursuant to Section 505 of Public Law 105-78, contract funds shall not be used
to carry out any program of distributing sterile needles or syringes for the
hypodermic injection of any illegal drug. Section 505, however, is subject to
the condition stated in Section 506. Specifically, Section 506 states that
after March 31, 1998, a program for exchanging needles and syringes for used
hypodermic needles and syringes may be carried out in a community if: (1) the
Secretary of Health and Human Services determines that exchange projects are
effective in preventing the spread of HIV and do not encourage the use of
illegal drugs; and (2) the project is operated in accordance with criteria
established by the Secretary for preventing the spread of HIV and for ensuring
that the project does not encourage the use of illegal drugs.
ARTICLE H.5. SALARY RATE LIMITATION LEGISLATION PROVISIONS
- -----------------------------------------------------------
a. Pursuant to Public Law(s) cited in paragraph b., below, no NIH Fiscal
Year funds for the applicable fiscal year(s) and periods cited in
paragraph b., below may be used to pay the direct salary of an
individual through this contract at a rate in excess of applicable
amount shown for the fiscal year and period covered. Direct salary is
exclusive of overhead, fringe benefits and general and administrative
expenses. The per year salary rate limit also applies to individuals
proposed under subcontracts. If this is a multi-year contract, it may
be subject to unilateral modifications by the Government if an
individual's salary rate exceeds any salary rate ceiling established in
future DHHS appropriation acts.
b. Dollar Amount of
Public Law No. Fiscal Year Period Covered Salary Limitation
-------------- ----------- -------------- -----------------
105-78 1998 10/01/1997-09/30/1998 $125,000
ARTICLE H.6. PUBLICATION AND PUBLICITY
- ---------------------------------------
13
Contract No. N01-HB-87144
The contractor shall acknowledge the support of the National Institutes of
Health whenever publicizing the work under this contract in any media by
including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds
from the National Heart, Lung, and Blood Institute, National Institutes
of Health, under Contract No. N01-HB-87144."
ARTICLE H.7. PRESS RELEASES
- ----------------------------
Pursuant to Section 508 of Public Law 105-78, the contractor shall clearly
state, when issuing statements, press released, requests for proposals, bid
solicitations and other documents describing projects or programs funded in
whole or in part with Federal money that: (1) the percentage of the total
costs of the program or project which will be financed with Federal Money; (2)
the dollar amount of Federal funds for the project or program; and (3) the
percentage and dollar amount of the total costs of the project or program that
will be financed by nongovernment sources.
ARTICLE H.8. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
- ----------------------------------------------------------------
Anyone who becomes aware of the existence or apparent existence of fraud, waste
and abuse in NIH funded programs is encouraged to report such matters to the
HHS inspector General's Office in writing or on the Inspector General's
Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All
telephone calls will be handled confidentially. The e-mail address is
Htips@os.dhhs.gov and the mailing address is:
- -----------------
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
P.O. Box 23489
Washington, D.C. 20026
Information regarding procedural matters is contained in the NIH Manual Chapter
1754, which is available on (http://www1.od.nih.gov/oma/oma.htm).
14
Contract No. N01-HB-87144
PART II
-------
SECTION I - CONTRACT CLAUSES
- ----------------------------
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
- -------------------------------------------------------------------------------
CONTRACT - FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)
- --------------------------------------------------------------------------
This contract incorporates the following clauses by reference, with the same
force and effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available. Also, the full text
of a clause may be accessed electronically at this address:
http://www.arnet.gov/far/.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
FAR
CLAUSE NO. TITLE AND DATE
52.202-1 Definitions (OCTOBER 1995)
52.203-3 Gratuities (Over $100,000) (APRIL 1984)
52.203-5 Covenant Against Contingent Fees (Over $100,000) (APRIL
1984)
52.203-6 Restrictions on Subcontractor Sales to the Government
(Over $100,000) (JULY 1995)
52.203-7 Anti-Kickback Procedures (Over $100,000) (JULY 1995)
52.203-8 Cancellation, Rescission, and Recovery of Funds for
Illegal or Improper Activity (Over $100,000) (JANUARY
1997)
52.203-10 Price or Fee Adjustment for Illegal or Improper
Activity (Over $100,000) (JANUARY 1997)
52.203-12 Limitation on Payments to Influence Certain Federal
Transactions (Over $100,000) (JUNE 1997)
52.204-4 Printing/Copying Double-Sided on Recycled Paper (Over
$100,000) (JUNE 1996)
52.209-6 Protecting the Government's Interests when
Subcontracting with Contractors Debarred, Suspended, or
Proposed for Debarment (Over $25,000) (JULY 1995)
52.215-2 Audit and Records - Negotiation (Over $100,000) (AUGUST
1996)
52.215-8 Order of Precedence-Uniform Contract Format (OCTOBER
1997)
52.215-10 Price Reduction for Defective Cost or Pricing Data
(Over $500,000) (OCTOBER 1997)
52.215-12 Subcontractor Cost or Pricing Data (Over $500,000)
(OCTOBER 1997)
52.215-14 Integrity of Unit Prices (Over $100,000) (OCTOBER 1997)
52.215-15 Termination of Defined Benefit Pension Plans (OCTOBER
1997)
52.215-18 Reversion or Adjustment of Plans for Post-Retirement
Benefits (PRB) other than Pensions (OCTOBER 1997)
15
Contract No. N01-HB-87144
52.215-19 Notification of Ownership Changes (OCTOBER 1997)
52.215-21 Requirements for Cost or Pricing Data or Information
Other Than Cost or Pricing Data--Modifications (OCTOBER
1997)
52.216-7 Allowable Cost and Payment (APRIL 1998)
52.216-8 Fixed Fee (MARCH 1997)
52.219-8 Utilization of Small, Small Disadvantaged, and
Women-Owned Small Business Concerns (Over $100,000)
(JUNE 1997)
52.219-9 Small, Small Disadvantaged, and Women-Owned Small
Business Subcontracting Plan (Over $500,000) (AUGUST
1996)
52.219-16 Liquidated Damages - Subcontracting Plan (Over
$500,000) (OCTOBER 1995)
52.222-2 Payment for Overtime Premium (Over $100,000) (JULY
1990) (NOTE: The dollar amount in paragraph (a) of this
clause is $0 unless otherwise specified in the
contract.)
52.222-3 Convict Labor (AUGUST 1996)
52.222-26 Equal Opportunity (APRIL 1984)
52.222-28 Equal Opportunity Preaward Clearance of Subcontracts
(Over $1,000,000) (APRIL 1984)
52.222-35 Affirmative Action for Disabled Veterans and Veterans
of the Vietnam Era (APRIL 1998)
52.222-36 Affirmative Action for Handicapped Workers (APRIL 1984)
52.222-37 Employment Reports on Disabled Veterans and Veterans of
the Vietnam Era (APRIL 1998)
52.223-2 Clean Air and Water (Over $100,000) (APRIL 1984)
52.223-6 Drug-Free Workplace (JANUARY 1997)
52.223-14 Toxic Chemical Release Reporting (OCTOBER 1996)
52.225-3 Buy American Act--Supplies (JANUARY 1994)
52.225-11 Restrictions on Certain Foreign Purchases (OCTOBER
1996)
52.227-1 Authorization and Consent (Over $50,000) (JULY
1995)--Alternate I (APRIL 1984)
52.227-2 Notice and Assistance Regarding Patent and Copyright
Infringement (Over $100,000) (AUGUST 1996)
52.227-11 Patent Rights - Retention by the Contractor (Short
Form) (JUNE 1997) NOTE: In accordance with FAR
27.303(a)(2),paragraph (f) is modified to include the
requirements in FAR 27.303(a)(2) (i) through (iv). The
frequency of reporting in (i) is annual.
16
Contract No. N01-HB-87144
52.227-14 Rights in Data - General (JUNE 1987)
52.232-9 Limitation on Withholding of Payments (APRIL 1984)
52.232-17 Interest (Over $100,000) (JUNE 1996)
52.232-20 Limitation of Cost (APRIL 1984)
52.232-23 Assignment of Claims (JANUARY 1986)
52.232-25 Prompt Payment (JUNE 1997)
52.232-33 Mandatory Information for Electronic Funds Transfer
Payment (AUGUST 1996)
52.233-1 Disputes (OCTOBER 1995)
52.233-3 Protest After Award (AUGUST 1996) With Alternate I
(JUNE 1985)
52.242-1 Notice of Intent to Disallow Costs (APRIL 1984)
52.242-3 Penalties for Unallowable Costs (Over $500,000)
(OCTOBER 1995)
52.242-4 Certification of Final Indirect Costs (JANUARY 1997)
52.242-13 Bankruptcy (Over $100,000) (JULY 1995)
52.243-2 Changes - Cost Reimbursement (AUGUST 1987) Alternate V
(APRIL 1984)
52.244-2 Subcontracts (Cost-Reimbursement and Letter Contracts)
(FEBRUARY 1997) *If written consent to subcontract is
required, the identified subcontracts are listed in
ARTICLE B, Advance Understandings.
52.244-5 Competition in Subcontracting (Over $100,000) (DECEMBER
1996)
52.245-5 Government Property (Cost-Reimbursement, Time and
Material, or Labor-Hour Contract) (JANUARY 1986)
52.246-23 Limitation of Liability (Over $100,000) (FEBRUARY 1997)
52.249-6 Termination (Cost-Reimbursement) (SEPTEMBER 1996)
52.249-14 Excusable Delays (APRIL 1984)
52.253-1 Computer Generated Forms (JANUARY 1991)
17
Contract No. N01-HB-87144
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR)
(48 CFR CHAPTER 3) CLAUSES:
HHSAR
CLAUSE NO. TITLE AND DATE
---------- --------------
352.202-1 Definitions (APRIL 1984) Alternate I (APRIL 1984)
352.228-7 Insurance - Liability to Third Persons (DECEMBER 1991)
352.232-9 Withholding of Contract Payments (APRIL 1984)
352.233-70 Litigation and Claims (APRIL 1984)
352.242-71 Final Decisions on Audit Findings (APRIL 1984)
352.270-5 Key Personnel (APRIL 1984)
352.270-6 Publication and Publicity (JULY 1991)
352.270-7 Paperwork Reduction Act (APRIL 1984)
End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
CONTRACT ]
ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES
- -----------------------------------------------
ARTICLE I.1. of this SECTION is hereby modified as follows:
FAR Clause 52.232-20, LIMITATION OF COST, is deleted in its entirety and FAR
Clause 52.232-22, LIMITATION OF FUNDS (APRIL 1984) is substituted therefor.
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES
- -----------------------------------------
This contract incorporates the following clauses by reference, with the same
force and effect, as if they were given in full text. Upon request, the
contracting officer will make their full text available.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
(1) FAR 52.223-3, Hazardous Material Identification and Material
Safety Data (JANUARY 1997), ALTERNATE I (JULY 1995).
(2) FAR 52.223-12, Refrigeration Equipment and Air Conditioners
(MAY 1995).
(3) FAR 52.232-18, Availability of Funds (APRIL 1984).
(4) FAR 52.237-3, Continuity of Services (JANUARY 1991).
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION/PUBLIC
HEALTH SERVICE ACQUISITION REGULATION (HHSAR)/(PHSAR) (48 CHAPTER 3)
CLAUSES:
(1) PHS 352.223-70, Safety and Health (Deviation) (AUGUST 1997).
18
Contract No. N01-HB-87144
c. NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:
The following clause is attached and made a part of this contract:
(1) NIH (RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB
Bulletin 81-16).
19
Contract No. N01-HB-87144
PART III
--------
SECTION J - LIST OF ATTACHMENTS
-------------------------------
The following documents are attached and incorporated in this contract:
1. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type
Contracts, NIH(RC)-1 (5/97), 4 pages.
2. Financial Report of Individual Project/Contract, NIH 2706, (5/97), 1
page.
3. Instructions for Completing form NIH 2706, Financial Report of
Individual Project/Contract, (5/97), 3 pages.
4. Safety and Health (Deviation) , PHSAR Clause 352.223-70, (8/97), 1
page.
5. Procurement of Certain Equipment, NIH(RC)-7, 4/1/84, 1 page.
6. Contractor-Acquired Government Property - Schedule I-B, dated June
1998, 1 page.
7. Property Acquired Under Predecessor Contract, Schedule II-A, dated June
1998, 1 page.
20
Contract No. N01-HB-87144
PART IV
-------
SECTION K - REPRESENTATIONS AND CERTIFICATIONS
- ----------------------------------------------
The following documents are incorporated by reference in this contract:
1. Representations and Certifications, dated October 17, 1997. .
END of the CONTRACT
-------------------
21
Contract No. N01-HB-87144
Property Acquired Under Predecessor Contract
--------------------------------------------
Schedule II-A
-------------
June 1998
See attached DHHS Report of Accountable Property (HHS-565), dated 3/16/98 and
10/29/97.
Attachment 6
Contract No. N01-HB-87144
Contractor-Acquired Government Property
---------------------------------------
Schedule I-B
------------
June 1998
Estimated
Description Quantity Unit Price Total
- ----------- -------- ---------- -----
So-Low freezer cabinet 36 $ 6,650 $239,400
Model C80-27, temperature range -40 degrees C
to -80 degrees C, 27 cu. ft. capacity
Attachment 6