EXHIBIT 10.29
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1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES
AWARD/CONTRACT UNDER DPAS (15 CFR 350) 1 24
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2. CONTRACT (Proc. inst. ident.) NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUEST PROJECT NO.
N01-HB-07148 January 1, 2000
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5. ISSUED BY CODE 6. ADMINISTERED BY (If other than Item 5) CODE
National Institutes of Health ----------- -----------
National Heart, Lung, and Blood Institute AIIN:268997148
0000 Xxxxxxxxx Xxxxx, (XXX 0), XXX 0000 OMB No. 0990-0115
Xxxxxxxx, XX 00000-0000
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7. NAME XXX XXXXXXX XX XXXXXXXXXX (Xx., xxxxxx, xxxx, xxxxxx, Xxxxx and ZIP Code) 8. DELIVERY
[ ] FOB ORIGIN [X] OTHER (See below)
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9. DISCOUNT FOR PROMPT PAYMENT
Gen-Probe, Inc.
00000 Xxxxxxx Xxxxxx Xxxxx X/X
Xxx Xxxxx, Xxxxxxxxxx 00000-0000
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10. SUBMIT INVOICES ITEM
(4 copies unless Section G, Article G.3.
--------------------------------------------------------------------------------- otherwise specified)
CODE FACILITY CODE TO THE ADDRESS SHOWN IN:
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11. SHIP TO/XXXX FOR CODE 12. PAYMENT WILL BE MADE BY CODE
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Section F, Article F.1. Section G, Article G.3
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13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION 14. ACCOUNTING AND APPROPRIATION DATA
CAN 0-8424361: FY '00 $3,100,000; CAN 6-8424361: FY '96 $1,522,739
[ ] 10 U.S.C. 2304(c) ( ) [ ] 41 U.S.C. 253(C) ( ) EIN 1-33-0044608-A1 OC 25.55 Doc Xx.000X0XX00000X XXXX# 115337123
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15A. ITEM 15B. SUPPLIES/SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT
NO.
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TITLE: Refinement of New Assays for Direct Detection of
Viral Nucleic Acids in Donated Organs
CONTRACT PERIOD: 1/1/2000 - 12/31/2002
CONTRACT TYPE: Cost Reimbursement, Completion
CURRENT OBLIGATION: ................................... 4,652,739.00
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15G. TOTAL AMOUNT OF CONTRACT $ 7,583,879.00
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16. TABLE OF CONTENTS
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[ ] SEC. DESCRIPTION PAGE(S) [ ] SEC. DESCRIPTION PAGE(S)
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PART I--THE SCHEDULE PART II--CONTRACT CLAUSES
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X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 18
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X B SUPPLIES OR SERVICES AND PRICE/COSTS 4 PART III--LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH
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X C DESCRIPTION/SPECS./WORK STATEMENT 6 X J LIST OF ATTACHMENTS 23
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X D PACKAGING AND MARKING 10 PART IV--REPRESENTATIONS AND INSTRUCTIONS
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X E INSPECTION AND ACCEPTANCE 10 REPRESENTATIONS, CERTIFICATIONS AND 24
---------------------------------------------------------------- K OTHER STATEMENTS OF OFFERORS
X F DELIVERIES OR PERFORMANCE 11 X
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X G CONTRACT ADMINISTRATION DATA 12 L INSTRS., CONDS., AND NOTICES TO OFFERORS
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X H SPECIAL CONTRACT REQUIREMENTS 14 M EVALUATION FACTORS FOR AWARD
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CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
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17 [X] CONTRACTOR'S NEGOTIATED AGREEMENT (Contractor is required 18 [ ] AWARD (Contractor is not required to sign this document.)
to sign this document and return 2 copies to issuing Your offer on Solicitation Number _______________________
office) Contractor agrees to furnish and deliver all items including the additions or changes made by you which
or perform all the services set forth or otherwise additions or changes are set forth in full above, is
identified above and on any continuation sheets for the hereby accepted as to the items listed above and on any
consideration stated herein. The rights and obligations continuation sheets. This award consummates the contract
of the parties to the contract shall be subject to and which consists of the following documents: (a) the
governed by the following documents: (a) this award/contract, Government's solicitation and your offer, and (b) this
(b) the solicitation, if any, and (c) such provisions, award/contract. No further contractual document is
representations, certifications, and specifications as are necessary.
attached or incorporated by reference herein. (Attachments
are listed herein.)
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19A. NAME AND TITLE OF SIGNER (Type or print) 20A. NAME OF CONTRACTING OFFICER
Xxxxx X. Xxxxxxxx
President and CEO Xxxxx X. Xxxxxxxx
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19B. NAME OF CONTRACTOR GEN-PROBE INC. 19C. DATE SIGNED 20B. XXXXXX XXXXXX XX XXXXXXX 00X. DATE SIGNED
BY /s/ XXXXX X. XXXXXXXX 10-Nov-99 BY /s/ XXXXX X. XXXXXXXX 11/15/99
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(Signature of person authorized to sign) (Signature of Contracting Officer)
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NSN 7540-01-152-8089 26-107 STANDARD FORM 26 (REV 4-85)
PREVIOUS EDITION UNUSABLE Prescribed by XXX
XXX (00 XXX) 53.214(a)
Contract No. N01-HB-07148
DETAILED TABLE OF CONTRACT CONTENTS
PART I - THE SCHEDULE
SECTION A - SOLICITATION/CONTRACT FORM
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS.................................................. 4
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES........................................ 4
ARTICLE B.2. ESTIMATED COST................................................................... 4
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS............................................ 4
ARTICLE B.4. ADVANCE UNDERSTANDINGS........................................................... 5
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT.............................................. 6
ARTICLE C.1. STATEMENT OF WORK................................................................ 6
ARTICLE C.2. REPORTING REQUIREMENTS........................................................... 9
SECTION D - PACKAGING, MARKING AND SHIPPING........................................................ l0
SECTION E - INSPECTION AND ACCEPTANCE.............................................................. 10
SECTION F - DELIVERIES OR PERFORMANCE.............................................................. 11
ARTICLE F.1. DELIVERIES....................................................................... 11
ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE................................................ 12
SECTION G - CONTRACT ADMINISTRATION DATA........................................................... 12
ARTICLE G.1. PROJECT OFFICER.................................................................. 12
ARTICLE G.2. KEY PERSONNEL.................................................................... 12
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST.................................... 12
ARTICLE G.4. INDIRECT COST RATES.............................................................. 13
ARTICLE G.5. GOVERNMENT PROPERTY.............................................................. 13
ARTICLE G.6. POST AWARD EVALUATION OF PAST PERFORMANCE........................................ 14
SECTION H - SPECIAL CONTRACT REQUIREMENTS.......................................................... 14
ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT PROJECTS......... 14
ARTICLE H.2. RESTRICTION FROM USE OF HUMAN SUBJECTS........................................... 14
ARTICLE H.3. HUMAN MATERIALS.................................................................. 14
ARTICLE H.4. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH................................ 15
ARTICLE H.5. NEEDLE EXCHANGE.................................................................. 15
ARTICLE H.6. PRIVACY ACT...................................................................... 15
ARTICLE H.7. SUBCONTRACTING PROVISIONS........................................................ 15
ARTICLE H.8. SALARY RATE LIMITATION LEGISLATION PROVISIONS.................................... 16
ARTICLE H.9. PUBLICATION AND PUBLICITY........................................................ 16
ARTICLE H.10. PRESS RELEASES.................................................................. 17
ARTICLE H.11. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE.............................. 17
2
PART II - CONTRACT CLAUSES............................................................................. 18
SECTION I - CONTRACT CLAUSES...................................................................... 18
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT...... 18
ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES.............................................. 20
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES..................................................... 21
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT........................... 21
PART III............................................................................................... 23
SECTION J - LIST OF ATTACHMENTS................................................................... 23
I. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts........ 23
II. Annual Technical Progress Report Format for Each Study.................................. 23
III. Safety and Health (Deviation), PHSAR Clause 352.223-70, (8/97), 1 page.................. 23
IV. Privacy Act System of Records No. 09-25-0200, (4/97), 3 pages........................... 23
V. Small Business Subcontracting Plan, dated 8/16/99, 7 pages.............................. 23
PART IV................................................................................................ 24
SECTION K - REPRESENTATIONS AND CERTIFICATIONS.................................................... 24
1. Representations and Certifications...................................................... 24
3
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The major objectives of this program are: 1) to refine for use in clinical
laboratories, one or more nucleic-acid based techniques that will be feasible
for the direct detection of blood-borne viruses in donors of organs for
transplantation to reduce the antibody-negative window period between
infectivity and detection to the shortest possible time and, when possible,
obviate the need for indirect antibody tests; and 2) to file for investigational
new drug exemption (IND) with the Food and Drug Administration (FDA), and submit
and obtain approval for product license applications (PLAs).
ARTICLE B.2. ESTIMATED COST
a. This is a cost-sharing contract. The total estimated cost of performing
the work under this contract is $17,583,879. For further provisions
regarding the specific cost-sharing arrangement, see ARTICLE B.4. ADVANCE
UNDERSTANDINGS.
b. For purpose of the clause of the General Clauses entitled LIMITATION OF
FUNDS, the total estimated cost to the Government is $7,583,879.
c. Total funds currently available for payment and allotted to this contract
are $4,652,739. For further provisions on funding, see the LIMITATION OF
FUNDS clause referenced in Part II, ARTICLE 1.2. Authorized Substitutions
of Clauses.
d. It is estimated that the amount currently allotted will cover performance
of the contract through June 15, 2001. The Contracting Officer may allot
additional funds to the contract without the concurrence of the
Contractor.
e. Future increments to be allotted to this contract are estimated as
follows:
PERIOD AMOUNT
6/16/01 - 12/31/02 $2,930,140
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
a. ITEMS UNALLOWABLE UNLESS OTHERWISE PROVIDED
Notwithstanding the clause[s], 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.);
(4) Travel to attend general scientific meetings;
(5) Foreign travel - See ARTICLE B.3.b.(2);
(6) Patient care costs;
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(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 Control of Government
Property), 1990, regardless of acquisition value.
b. TRAVEL COSTS
(1) Domestic Travel
(a) Total expenditures for domestic travel (transportation,
lodging, subsistence, and incidental expenses) incurred in
direct performance of this contract shall not exceed $57,200
without the prior written approval of the Contracting Officer.
(b) The Contractor shall invoice and be reimbursed for all travel
costs in accordance with Federal Acquisition Regulations (FAR)
31.205-46.
(2) Foreign Travel
Requests for foreign travel must be submitted at least three weeks
in advance and shall contain the following: (a) meeting(s) and
place(s) to be visited, with costs and dates; (b) name(s) and
title(s) of Contractor personnel to travel and their functions in
the contract project; (c) contract purposes to be served by the
travel; (d) how travel of contractor personnel will benefit and
contribute to accomplishing the contract project, or will otherwise
justify the expenditure of NIH contract funds; (e) how such
advantages justify the costs for travel and absence from the project
of more than one person if such are suggested; and (f) what
additional functions may be performed by the travelers to accomplish
other purposes of the contract and thus further benefit the project.
ARTICLE B.4. ADVANCE UNDERSTANDINGS
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. INDIRECT COSTS
(1) In no event shall the final amount reimbursable for indirect costs
(including overhead, G&A, and fringe benefits) exceed a ceiling of
125% of direct labor during the entire period of this contract.
(2) The Government is not obligated to pay any additional amount should
the final indirect cost rates exceed this negotiated ceiling rate.
In the event that the final indirect cost rates are less than this
negotiated ceiling rate, the final negotiated ceiling rate shall be
reduced to conform to the lower rate.
Any costs over and above this cost ceiling shall not be reimbursed
under this contract or any other Government contract, grant, or
cooperative agreement.
(3) The Contractor shall complete all work in accordance with the
Statement of Work, terms and conditions of this contract.
b. SUBCONTRACT
A cost-reimbursement type subcontract with Westat, Inc. for developing,
conducting, and analyzing the clinical studies in Phase II in the
estimated cost of $968,959 plus a fixed fee of $67,828. A copy of the
subcontract agreement shall be provided to the Contracting Officer.
c. COST SHARING
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(1) This is a cost-sharing contract. Monies shall be provided for the
total cost of performance from the National Institutes of Health,
National Heart, Lung, and Blood Institute and Gen-Probe
Incorporated.
(2) The Government shall provide monies in an amount not to exceed
$7,583,879. The Contractor's share is estimated at $10,000,000 OR
57% of the total estimated cost set forth in ARTICLE B.2. ESTIMATED
COST, paragraph a.
(3) The Contractor shall maintain records of all contract costs
(including costs claimed by the Contractor as being its share) and
such records shall be subject to the AUDIT AND RECORDS clause of the
General Clauses.
(4) Costs contributed by the Contractor shall not be charged to the
Government under any other contract, grant, or cooperative agreement
(including allocation to other grants, contracts, or cooperative
agreements as part of an independent research and development
program). The Contractor shall report the organization's share of
the costs on its invoices to the Government as referenced in ARTICLE
B.4.d.(1).
d. INVOICES - COST AND PERSONNEL REPORTING, AND VARIANCES FROM THE NEGOTIATED
BUDGET
(1) The contractor agrees to provide a detailed breakdown on invoices of
the following cost categories:
(a) Direct Labor - List individuals by name, title/position,
hourly/annual rate, level of effort, and amount claimed.
(b) Materials
(c) Travel
(d) Subcontractor Westat, Inc. - Attach subcontractor's
invoice(s).
(e) Specimen Procurement
(f) Development Lots
(g) Total Direct Cost
(h) Overhead + G&A + Fringe Benefits @ 125% of Direct Labor
(i) Total Billing Cost (NHLBI)
(j) Clinical Trial Reagents
(k) Subcontractor - Xxxxxxxxxx Development, Inc.
(1) Total Gen-Probe Share
Monthly invoices must include the cumulative total expenses to date,
adjusted (as applicable) to show any amounts suspended by the
Government.
(2) The contractor agrees to immediately notify the contracting officer
in writing if there is an anticipated overrun (any amount) or
unexpended balance (greater than 10 percent) of the amount allotted
to the contract, and the reasons for the variance. Also refer to the
requirements of the Limitation of Funds and Limitation of Cost
Clauses in the contract.
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1. STATEMENT OF WORK
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:
The contractor shall deliver the items specified in ARTICLE F.1 to the
destinations indicated.
The contractor shall: 1) Refine for use in clinical laboratories, one or
more nucleic-acid based techniques that will be feasible for the direct
detection of blood-borne viruses in donors of organs for transplantation
to reduce the antibody-
6
negative window period of infectivity and detection to the shortest
possible time and, when possible, obviate the need for antibody tests: and
2) file for INDs with the Food and Drug Administration (FDA), and submit
and obtain approval for product license applications (PLAs).
The study schedule is as follows:
Phase I: Preclinical Phase
The preclinical phase for refinement of an organ donor assay shall be
completed within 24 months from contract award.
Phase II: Clinical Phase
All clinical studies conducted at approved clinical trial sites must be
completed and the results submitted to the Center for Biologies Evaluation
and Research (CBER) within a period of 8 months from receipt of the
investigational new drug (IND). An additional 4 months will allow for
review of data by CBER officials and, ultimately, licensure of the
procedure. The contractor shall perform the following activities:
PHASE I: Preclinical Studies/Test Refinement
1. Refine a procedure for screening of organ donors for blood-borne
viruses. The contractor must:
a. Demonstrate that the organ donor assay detects minimal amounts
of viral nucleic acids (RNA and/or other viral nucleic acids
that appear at the same time or before the earliest appearance
of viral RNA circulating in plasma) specific for HIV-1 and
HCV. If specimens other than blood are to be used, determine
the best tissue to use as a test material source.
b. Have and describe plans to adapt the test methods to a
multiplexing format that will detect multiple blood borne
viruses (two or more viruses) in the same test. The two
highest priority viruses to be detected are HIV-1 and HCV.
The testing method(s) proposed must be able to detect each of
these viruses, in multiplexing format. If additional viruses
are included in the test system (e.g., HBV, HIV-2, etc.), they
are also to be incorporated into a multiplex format.
c. Demonstrate that these assays are suitable for use on blood or
tissue samples from organ donors.
d. Provide a technically easy procedure so as to be readily
usable by less practiced laboratory staff at odd hours, day or
night, weekday or weekend.
e. Provide a test that is rapid (<4-6 hours from sample receipt
to report), highly specific and sensitive.
f. Propose and begin to develop a confirmatory test for the
viruses initially targeted, unless the base procedure is 100%
specific.
2. Validate assay(s) and subject them to process controls.
3. Utilize good laboratory practices to ensure the acquisition of
acceptable supporting data for the submission of INDs and PLAs to
the FDA.
4. Address carefully issues related to the FDA's general regulatory
concerns regarding IND approval. Important points to be considered
include preparation and processing of specimens; selection of target
nucleic acid species; genetic drift or mutation of targeted
infectious agents; development and standardization of capture and
reporter probes; construction of internal controls for human
RNA/DNA, non-target sequences of the same infectious agent, and
different pathogens; determining optimum tissue source for test
sample in the case of screening organ donors; quality control of the
manufacturing process; and design of preclinical evaluation studies.
The NHLBI must be notified and usually present at any meetings with
the FDA and the contractor and/or such subcontractors as may exist
that relate
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to this project or any part thereof.
5. Develop a standardized test protocol that will be used for
preclinical testing including: (i) Evaluation of specificity, (ii)
evaluation of sensitivity with validation of end-point, and (iii)
studies to determine the analytical sensitivities for the clinical
trial tests. Biostatistical considerations indicate that at least
600 specificity specimens will be necessary to validate the
procedure. If the assay material is blood, random normal blood or
plasma donor specimens and at least 100 test-positive sensitivity
specimens shall be used. If the test material is tissue (lymph node
aspirate, bone marrow, etc.), specimens of the same type of tissue
shall be utilized. Preclinical testing must be completed to submit
an IND and proceed to the clinical trial testing.
The NHLBI blood specimen repository has been storing specimens from
a variety of epidemiological studies supported by the Institute
since 1974. The repository contains blood samples from 6
sequentially bled hemophiliacs who became infected with HIV during
the course of a large study. Another source of sequential specimens
for detecting HIV nucleic acids during the seronegative window of
infectivity is the collection of plasma and serum from the NHLBI
longitudinal study of approximately 14 chimpanzees experimentally
infected with HIV. In addition, the Institute's blood specimen
repository has serial samples from over 100 blood recipients who
developed post-transfusion HCV. These specimens will be used to
prepare coded panels which the Institute will make available to the
contractor to satisfy at least some of the needs for data to support
either the IND or the PLA applications. The contractor must have or
develop additional sources of samples to fulfill the requirements
for test licensure.
6. Submit IND applications in accordance with FDA policies and
guidelines.
7. Propose an acceptable comparative test(s), providing data on which
to base its use as a "gold standard," since there is no "gold
standard" licensed test that can be used to confirm the
test-positive specimens. This test could also be proposed as a
confirmatory test.
PHASE II: Clinical Trials/Test Validation
Commencement of Phase II is contingent on successful completion of
Phase I. Phase II shall not proceed without the prior written
approval of the Contracting Officer. Phase II will be the actual
implementation of the definitive clinical trials to support
licensure.
Specifically, the contractor shall provide the following:
1. Design and organize the definitive clinical studies to support a
PLA. These studies shall be performed by independent investigators
at clinical trial sites that mimic expected use, i.e., a test
intended for screening of organ donors must be validated in a
transplantation or transplantation-like setting. The contractor
shall propose how the investigational assay system will be compared
to the proposed "gold standard" system and how discrepant results
will be resolved. Specimens evaluated in the clinical trial may be
either linked or unlinked to human subjects. A study with linked
samples requires Institutional Review Board (IRB) approval and the
informed consent of the donor or donor's family.
2. Conduct specificity testing with specimens of blood or tissue from
organ donors and potential organ donors to mimic the clinical
situation. Testing must be done at odd hours, day or night, weekday
or weekend, similar to the timing of the recruitment of organ
donors.
3. Determine sensitivity and specificity with an estimated confidence
limit, describing how the limit was selected and how the study will
provide it. If the test material is tissue, (e.g. lymph node
aspirate, bone marrow, etc.), experimental protocols utilizing
chimpanzees may be valuable. These animals, infected with HIV, could
be the source of invaluable longitudinal specimens which could
demonstrate the sensitivity of the assay in detecting HIV during the
seronegative window of infectivity.
4. Perform nonspecificity studies for each virus with at least 200
samples to determine whether certain specimens will produce
non-specific results. These shall include samples from individuals
with diverse viral diseases who could
8
have high levels of non-specific nucleic acids that might interfere
with the test. In addition, because "viral drift" may potentially
result in decreased sensitivity, these samples shall include some
geographically diverse samples.
b. The following described document is hereby made a part of this contract:
Pages 3-1, 4-1, 4-6 (starting with paragraph 4.b.1), 4-7, 4-8 (stopping
at paragraph 4.b.1.1), 4-19 (starting with paragraph 4.b.2) thru page 4-48
(stopping at paragraph 4.c) of the contractor's Technical proposal dated
February 10, 1999; subsequent written responses dated June 22, 1999; and
the Final Proposal Revisions dated August 18, 1999.
c. If there is any inconsistency between the referenced proposal and the work
described in this ARTICLE, Paragraph a., shall control.
ARTICLE C.2. REPORTING REQUIREMENTS
a. TECHNICAL REPORTS
In addition to those reports required by SECTION I and 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:
a. QUARTERLY REPORTS; to include a description of the activities during
the reporting period including subcontract activities. The narrative
must include how progress in the particular quarter compares with
progress predicted on a pert chart (or other project management
charting) prepared by the contractor. Identify any problems that
have arisen and how they have been or will be resolved. Activities
planned for the ensuing reporting period shall be discussed. Five
copies will be due 14 calendar days after the end of each quarter.
b. ANNUAL REPORTS; to include a summation of the results of the entire
contract work for the period covered. The annual report should
include the significant data obtained during the year and identify
progress in relationship to the objectives outlined at the beginning
of the year. Significant technical problems should be clearly
identified. The narrative must include how progress over the annual
period compares with progress predicted on a pert chart (or other
project management charting) prepared by the contractor. In
addition, a projection of the next year's technical activities shall
be included. The report must identify the objectives originally
planned for the subsequent funding period and justify any deviation
from this plan. It must indicate the procedures to be employed to
overcome any significant technical problems encountered during the
reporting period. A Quarterly Report shall not be submitted when an
Annual Report is due.
The progress chart shall serve as the basis for assessing the actual
progress during the particular reporting period. Any deviation from
the progress chart must be explained and corrective measures shall
be discussed. If necessary, the progress chart shall be readjusted
to reflect the true progress achieved and future work to be
performed. The first annual report shall be submitted within 12
months after the effective date of the contract and annually
thereafter (specific dates shall be stated in the contract). An
original and 5 copies are required.
c. DRAFT FINAL REPORT; the Contractor shall provide the Contracting
Officer with two copies of the final report in draft form 30 working
days before the Final Report is due. The Project Officer shall
review the draft report and provide the Contractor with comments
within 15 working days after receipt. The final report shall be
corrected if necessary and the final version delivered by or before
the expiration date of the contract.
d. FINAL REPORT; to include a summation of the work performed and
results obtained for the entire contract period of performance. This
report shall be in sufficient detail to describe comprehensively the
results achieved. The final report shall be submitted upon
completion of contract objectives. The Contractor shall submit, with
the final report, a summary (not to exceed 200 words) of salient
results achieved during the performance of the contract. An original
and 20 copies will be required.
9
e. OTHER REPORTS/DELIVERABLES
1. PROGRESS REPORT FOR CLINICAL RESEARCH STUDY POPULATIONS
If linked specimens are used in the study, the Contractor shall
submit the following information for each study being performed
under this contract in the format presented below. The report shall
be submitted in accordance with ARTICLE F.1. DELIVERIES of this
contract.
PROGRESS REPORT FORMAT FOR EACH STUDY
Study Title:
Date:
Provide the number of subjects enrolled in the study to date according to the
following categories:
=============================================================================================================================
American Black, White,
Indian or Asian or not of not of Other
Alaskan Pacific Hispanic Hispanic or
Native Islander Origin Hispanic Origin Unknown Total
=============================================================================================================================
Female
-----------------------------------------------------------------------------------------------------------------------------
Male
-----------------------------------------------------------------------------------------------------------------------------
Unknown
-----------------------------------------------------------------------------------------------------------------------------
TOTAL
=============================================================================================================================
Subpopulations of the minority groups should also be reported, using a similar
format.
SECTION D - PACKAGING, MARKING AND SHIPPING
All deliverables required under this contract shall be packaged, marked and
shipped in accordance with Government specifications. At a minimum, all
deliverables shall be marked with the contract number and name. The Contractor
shall guarantee that all required materials shall be delivered in immediate
usable and acceptable condition.
SECTION E - INSPECTION AND ACCEPTANCE
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:
National Heart, Lung, and Blood Institute
National Institutes of Health
Rockledge II (RKL2)
0000 Xxxxxxxxx Xxxxx, Xxxx 00000
Xxxxxxxx, XX 00000-0000
Acceptance may be presumed unless otherwise indicated in writing by the
Contracting Officer or the duly authorized representative within 30 days
of receipt.
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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. 52.246-9, INSPECTION OF RESEARCH & DEVELOPMENT (SHORT FORM)
(APRIL 1984).
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. DELIVERIES
Satisfactory performance of the final 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:
a. The items specified below as described in SECTION C, ARTICLE C.1. will be
required to be delivered 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 date(s) specified below:
ITEM DESCRIPTION QUANTITY DELIVERY SCHEDULE
---- ----------- -------- -----------------
(a) Quarterly Reports w/progress chart Original & 5 copies Quarterly
(b) Annual Reports w/progress chart Original & 5 copies 12/31/00, 12/31/01
(c) Draft Final Report 2 copies 11/19/02
(d) Final Report Original & 20 copies 12/31/02
(e) Contractor/CBER Related Documents 2 Copies See below
(f) Progress Report for Clinical Research Original & 5 copies 12/31/00, 12/31/01, 12/31/02
In addition to quarterly and annual progress reports, the contractor shall
make available to the government a copy of the progress chart related to
the projected course of the workscope. Also, copies of documents related
to negotiations between the contractor and CBER officials shall be
submitted to the Project Officer within two weeks of said negotiations.
This shall include preclinical and clinical protocols as well as
information from the study.
b. One copy of each deliverable shall be sent to the Contracting Officer. All
other copies shall be furnished to the Project Officer. All reports shall
be mailed or otherwise delivered to the following addresses:
Contracting Officer Project Officer
National Heart, Lung, and National Heart, Lung, and
Blood Institute Blood Institute
Two Rockledge Center, Room 0000 Xxx Xxxxxxxxx Xxxxxx, Xxxx 00000
0000 Xxxxxxxxx Xxxxx, XXX 0000 0000 Xxxxxxxxx Xxxxx, XXX 0000
Bethesda, Md. 20892-7902 Bethesda, Md. 20892-7950
OTHER DELIVERABLES:
One copy of each deliverable below shall be sent to the Contracting
Officer at the address shown above.
g. OPTIONAL FORM 310: or equivalent certifying IRB review and approval of the
protocol. Documentation of IRB approval shall be provided at the
completion of Phase I.
h. SF 294 REPORT: Subcontracting Report for Individual Projects shall be
submitted semi-annually.
11
ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)
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: xxxx://xxx.xxxxx.xxx/xxx/.
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
52.242-15, Stop Work Order (AUGUST 1989) with ALTERNATE I (APRIL 1984).
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. PROJECT OFFICER
The following Project Officer(s) will represent the Government for the purpose
of this contract:
Xxxxxx Nemo, Ph.D.
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 Contracting Officer hereby delegates the Project Officer as the Contracting
Officer's authorized representative responsible for signing software license
agreements issued as a result of this contract.]
The Government may unilaterally change its Project Officer designation.
ARTICLE G.2. KEY PERSONNEL
Pursuant to the Key Personnel clause incorporated in this contract, the
following individual(s) is/are considered to be essential to the work being
performed hereunder:
NAME TITLE
Xxxxxxx Xxxx, Ph.D. Principal Investigator
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST
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
12
be followed to meet the requirements of a "proper" payment request pursuant to
FAR 32.9.
(1) Invoices/financing requests shall be submitted as follows:
An original and two copies to the following designated billing office:
Contracting Officer
National Heart, Lung, and Blood Institute
Two Rockledge Center, Room 6134
6701 Xxxxxxxxx Xxxxx, XXX 0000
Bethesda, Md. 20892-7902
(2) Inquiries regarding payment of invoices should be directed to the
designated billing office, (000) 000-0000.
b. The Contractor shall include the following certification on every invoice
for reimbursable costs incurred with Fiscal Year funds subject to the salary
rate limitation provisions as specified in ARTICLE H.8. 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.105-277 and ARTICLE H.6. of the above referenced
contract."
ARTICLE G.4. INDIRECT COST RATES
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:
Director, Division of Financial Advisory Services
Office of Contracts Management
National Institutes of Health
6100 Building, Room 6B05
0000 XXXXXXXXX XXXX XXX-0000
XXXXXXXX XX 00000-0000
These rates are hereby incorporated without further action of the Contracting
Officer, but in no event shall the contractor's combined overhead, G&A, and
fringe benefits rate exceed 125% of direct labor during the entire period of
this contract.
ARTICLE G.5. GOVERNMENT PROPERTY
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
Administrator.
This contract's Contract Property Administrator is:
Xxxxx Xxxxxxxxx
Contracts Property Administrator
Research Contracts Property Xxxxxxxxxxxxxx, XXX
0000 Xxxxxxxx, Xxxx 000X
0000 XXXXXXXXX XXXX MSC 7670
13
XXXXXXXX XX 00000-0000
(000) 000-0000
ARTICLE G.6. 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. In addition to the final evaluation,
interim evaluations will be prepared annually to coincide with the anniversary
date of the contract.
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 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. RESTRICTION FROM USE OF HUMAN SUBJECTS
NOTICE: UNDER GOVERNING REGULATIONS, FEDERAL FUNDS ADMINISTERED BY THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES SHALL NOT BE EXPENDED FOR RESEARCH
INVOLVING HUMAN SUBJECTS, AND INDIVIDUALS SHALL NOT BE ENROLLED IN SUCH
RESEARCH, WITHOUT PRIOR APPROVAL BY THE OFFICE FOR PROTECTION FROM RESEARCH
RISKS (OPRR) OF AN ASSURANCE TO COMPLY WITH THE REQUIREMENTS OF 45 CFR 46 TO
PROTECT HUMAN RESEARCH SUBJECTS. THIS RESTRICTION APPLIES TO ALL COLLABORATING
SITES WITHOUT OPRR-APPROVED ASSURANCES, WHETHER DOMESTIC OR FOREIGN, AND
COMPLIANCE MUST BE ENSURED BY THE AWARDEE.
ARTICLE H.3. HUMAN MATERIALS
It is understood that the acquisition and supply of all human specimen material
(including fetal material) used under this contract will be obtained by the
Contractor in full compliance with applicable State and Local laws and the
provisions of the Uniform Anatomical Gift Act in the United States and that no
undue inducements, monetary or otherwise, will be offered to any person to
influence their donation of human material.
14
ARTICLE H.4. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
a. Pursuant to Public Law cited in paragraph b., below, NIH is prohibited 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 enactment
of this 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.
b. PUBLIC LAW AND SECTION NO. FISCAL YEAR PERIOD COVERED
-------------------------- ----------- --------------
P.L. 105-277 Section 511 1999 10/1/98 - 9/30/99
ARTICLE H.5. NEEDLE EXCHANGE
a. Pursuant to Public Law(s) cited in paragraph b., below, 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.
b. PUBLIC LAW AND SECTION NO. FISCAL YEAR PERIOD COVERED
-------------------------- ----------- --------------
PL.105-277 Section 505 1999 10/1/98 - 9/30/99
ARTICLE H.6. PRIVACY ACT
This procurement action requires the Contractor to do one or more of the
following: design, develop, or operate a system of records on individuals to
accomplish an agency function in accordance with the Privacy Act of 1974, Public
Law 93-579, December 31, 1974 (5 USC 522a) and applicable agency regulations.
Violation of the Act may involve the imposition of criminal penalties.
The Privacy Act System of Records applicable to the project is Number
09-25-0200. This document is incorporated into this contract as Attachment IV.
ARTICLE H.7. SUBCONTRACTING PROVISIONS
a. SMALL BUSINESS SUBCONTRACTING PLAN
(1) The Small Business Subcontracting Plan, dated 10/18/99 is attached
hereto and made a part of this contract.
(2) The failure of any Contractor or subcontractor to comply in good faith
with FAR Clause 52.219-8, entitled "Utilization of Small Business
Concerns" incorporated in this contract and the attached Subcontracting
Plan, will be a material breach of such contract or subcontract and
subject to the remedies reserved to the Government under FAR Clause
52.219-16 entitled, "Liquidated Damages-Subcontracting Plan."
b. SUBCONTRACTING REPORTS
(1) The Contractor shall submit the original and 1 copy of Subcontracting
Report for Individual Contracts, SF-294 in accordance with the
instructions on the report as referenced in Public Law 95-507, Section
211. Regardless of the effective date of this contract, the Report shall
be submitted on the following dates for the entire life of this
contract:
April 30th
15
October 30th
The Report shall be sent to the following address:
Contracting Officer
Contracts Operations Branch
National Heart, Lung, and Blood Institute
Two Rockledge Center, Room 6134
6701 Xxxxxxxxx Xxxxx, XXX 0000
Bethesda, Md. 20892-7902
(2) The Contractor shall submit 1 copy of Summary Subcontract Report, SF-295
in accordance with the instructions on the report as referenced in
Public Law 95-507, Section 211. The Summary Subcontract Report shall be
submitted annually on the following date for the entire life of this
contract:
October 30th
The first report shall be submitted after the first full year of this
contract in addition to any fractional part of the year in which this
contract became effective. This Report shall be mailed to the following
address:
Office of Small and Disadvantaged Business Utilization
Department of Health and Human Services
Xxxxxx X. Xxxxxxxx Bldg., Room 517-D
000 Xxxxxxxxxxxx Xxxxxx, X.X.
Xxxxxxxxxx, X.X. 00000
(3) The contractor shall also send an "Information Copy" of the SF-295 to
the Cognizant Commercial Representative (CMR) at the address provided by
the SBA. The Contractor should call SBA Headquarters in Washington, DC
at (000) 000-0000 for the correct address if unknown.
ARTICLE H.8. 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.
DOLLAR AMOUNT OF
b. PUBLIC LAW NO. FISCAL YEAR PERIOD COVERED SALARY LIMITATION
-------------- ----------- -------------- -----------------
105-277 1999 10/1/98 - 9/30/99 $125,900
ARTICLE H.9. PUBLICATION AND PUBLICITY
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. NHLBI-HB-97148."
16
ARTICLE H.10. PRESS RELEASES
a. Pursuant to Public Law(s) cited in paragraph b., below, the contractor shall
clearly state, when issuing statements, press releases, requests for
proposals, bid solicitations and other documents describing projects or
programs funded in whole or in part with Federal money: (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 nongovernmental sources.
b. PUBLIC LAW AND SECTION NO. FISCAL YEAR PERIOD COVERED
PL.105-277 Section 507 1999 10/1/98 - 9/30/99
ARTICLE H.11. 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 0-000-XXX-XXXX (0-000-000-0000). All telephone calls will
be handled confidentially. The e-mail address is Htips@os.dhhs.eov and the
mailing address is:
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
X.X. Xxx 00000
Xxxxxxxxxx, X.X. 00000
Information regarding procedural matters is contained in the NIH Manual Chapter
1754, which is available on (xxxx://xxxx.xx.xxx.xxx/xxx/xxx.xxx)
17
PART II - CONTRACT CLAUSES
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:
xxxx://xxx.xxxxx.xxx/xxx/.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
FAR
CLAUSE NO. DATE TITLE
---------- -------- -----
52.202-1 Oct 1995 Definitions
52.203-3 Apr 1984 Gratuities (Over $100,000)
52.203-5 Apr 1984 Covenant Against Contingent Fees (Over $100,000)
52.203-6 Jul 1995 Restrictions on Subcontractor Sales to the Government (Over $100,000)
52.203-7 Jul 1995 Anti-Kickback Procedures (Over $100,000)
52.203-8 Jan 1997 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
(Over $100,000)
52.203-10 Jan 1997 Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000)
52.203-12 Jun 1997 Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)
52.204-4 Jun 1996 Printing/Copying Double-Sided on Recycled Paper (Over $100,000)
52.209-6 Jul 1995 Protecting the Government's Interests When Subcontracting With Contractors
Debarred, Suspended, or Proposed for Debarment (Over $25,000)
52.215-2 Jun 1999 Audit and Records - Negotiation (Over $100,000)
52.215-8 Oct 1997 Order of Precedence - Uniform Contract Format
52.215-10 Oct 1997 Price Reduction for Defective Cost or Pricing Data
52.215-12 Oct 1997 Subcontractor Cost or Pricing Data (Over $500,000)
52.215-14 Oct 1997 Integrity of Unit Prices (Over $100,000)
52.215-15 Dec 1998 Pension Adjustments and Asset Reversions
52.215-18 Oct 1997 Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than
Pensions
52.215-19 Oct 1997 Notification of Ownership Changes
52.215-21 Oct 1997 Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing
Data - Modifications
18
52.216-7 Apr 1998 Allowable Cost and Payment
52.216-8 Mar 1997 Fixed Fee
52.219-8 Jun 1999 Utilization of Small Business Concerns (Over $100,000)
52.219-9 Jan 1999 Small Business Subcontracting Plan (Over $500,000)
52.219-16 Jan 1999 Liquidated Damages - Subcontracting Plan (Over $500,000)
52.222-2 Ju1 1990 Payment for Overtime Premium (Over $100,000) (Note: The dollar amount in
paragraph (a) of this clause is $0 unless otherwise specified in the contract.)
52.222-3 Aug 1996 Convict Labor
52.222-26 Feb 1999 Equal Opportunity
52.222-35 Apr 1998 Affirmative Action for Disabled Veterans and Veterans of the Vietnam Era
52.222-36 Jun 1998 Affirmative Action for Workers with Disabilities
52.222-37 Jan 1999 Employment Reports on Disabled Veterans and Veterans of the Vietnam Era
52.223-2 Apr 1984 Clean Air and Water (Over $100,000)
52.223-6 Jan 1997 Drug-Free Workplace
52.223-14 Oct 1996 Toxic Chemical Release Reporting
52.225-3 Jan 1994 Buy American Act - Supplies
52.225-11 Aug 1998 Restrictions on Certain Foreign Purchases
52.227-1 Jul 1995 Authorization and Consent, Alternate I (Apr 1984)
52.227-2 Aug 1996 Notice and Assistance Regarding Patent and Copyright Infringement (Over
$100,000)
52.227-11 Jun 1997
Patent Rights - Retention by the Contractor (Short Form) (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.
52.227-14 Jun 1987 Rights in Data - General
52.232-9 Apr 1984 Limitation on Withholding of Payments
52.232-17 Jun 1996 Interest (Over $100,000)
52.232-20 Apr 1984 Limitation of Cost
52.232-23 Jan 1986 Assignment of Claims
52.232-25 Jun 1997 Prompt Payment
52.232-34 May 1999 Payment by Electronic Funds Transfer--Other Than Central Contractor Registration
52.233-1 Dec 1998 Disputes
52.233-3 Aug 1996 Protest After Award, Alternate I (Jun 1985)
52.242-1 Apr 1984 Notice of Intent to Disallow Costs
19
52.242-3 Oct 1995 Penalties for Unallowable Costs (Over $500,000)
52.242-4 Jan 1997 Certification of Final Indirect Costs
52.242-13 Jul 1995 Bankruptcy (Over $100,000)
52.243-2 Aug 1987 Changes - Cost Reimbursement, Alternate V (Apr 1984)
52.244-2 Aug 1998 Subcontracts, Alternate II (Aug 1998) *If written consent to subcontract is
required, the identified subcontracts are listed in ARTICLE B, Advance
Understandings.
52.244-5 Dec 1996 Competition in Subcontracting (Over $100,000)
52.245-5 Jan 1986 Government Property (Cost-Reimbursement, Time and Material, or Labor-Hour
Contract)
52.246-23 Feb 1997 Limitation of Liability (Over $100,000)
52.249-6 Sep 1996 Termination (Cost-Reimbursement)
52.249-14 Apr 1984 Excusable Delays
52.253-1 Jan 1991 Computer Generated Forms
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CFR CHAPTER 3) CLAUSES:
HHSAR
CLAUSE NO. DATE TITLE
352.228-7 Dec 1991 Insurance - Liability to Third Persons
352.232-9 Apr 1984 Withholding of Contract Payments
352.233-70 Apr 1984 Litigation and Claims
352.242-71 Apr 1984 Final Decisions on Audit Findings
352.270-5 Apr 1984 Key Personnel
352.270-6 Jul 1991 Publication and Publicity
352.270-7 Apr 1984 Paperwork Reduction Act
[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
CONTRACT-Rev. 7/1999].
ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES
FAR Clause 52.216-8, FIXED FEE (MARCH 1997), is deleted in its entirety and FAR
Clause 52.216-11, COST CONTRACT-NO FEE (APRIL 1984) is substituted therefor.
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.
20
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 52.215-17, Waiver of Facilities Capital Cost of Money (OCTOBER
1997).
(2) FAR 52.223-3, Hazardous Material Identification and Material Safety Data
(JANUARY 1997), ALTERNATE I (JULY 1995).
(3) FAR 52.224-1, Privacy Act Notification (APRIL 1984)
(4) FAR 52.224-2, Privacy Act (APRIL 1984)
(5) FAR 52.227-14, Rights in Data - General (JUNE 1987).
(6) FAR 52.227-16, Additional Data Requirements (JUNE 1987).
(7) FAR 52.230-3, Disclosure and Consistency of Cost Accounting Practices
(APRIL 1998).
(8) FAR 52.246-23, Limitation of Liability (FEBRUARY 1997). AND/OR
(9) FAR 52.246-24, Limitation of Liability - High-Value Items (FEBRUARY
1997).
(10) FAR 52.251-1, Government Supply Sources (APRIL 1984).
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).
(2) PHS 352.280-1b, Protection of Human Subjects (OCTOBER 1986).
c. NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:
The following clauses are attached and made a part of this contract:
(1) NIH (RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB Bulletin
81-16).
ARTICLE 1.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
This contract incorporates the following clauses in full text.
FEDERAL ACQUISITION REGULATION (FAR)(48 CFR CHAPTER l) CLAUSES:
a. FAR Clause 52.244-6, SUBCONTRACTS FOR COMMERCIAL ITEMS AND COMMERCIAL
COMPONENTS (OCTOBER 1998)
(a) DEFINITION.
21
Commercial item, as used in this clause, has the meaning contained in the
clause at 52.202-1, Definitions.
SUBCONTRACT, as used in this clause, includes a transfer of commercial items
between divisions, subsidiaries, or affiliates of the Contractor or
subcontractor at any tier.
(b) To the maximum extent practicable, the Contractor shall incorporate, and
require its subcontractors at all tiers to incorporate, commercial items or
nondevelopmental items as components of items to be supplied under this
contract.
(c) Notwithstanding any other clause of this contract, the Contractor is not
required to include any FAR provision or clause, other than those listed
below to the extent they are applicable and as may be required to establish
the reasonableness of prices under Part 15, in a subcontract at any tier for
commercial items or commercial components:
(1) 52.222-26, Equal Opportunity (E.O. 11246);
(2) 52.222-35, Affirmative Action for Disabled Veterans and Veterans of the
Vietnam Era (38 U.S.C. 4212(a));
(3) 52.222-36, Affirmative Action for Workers with Disabilities (29 U.S.C.
793); and
(4) 52.247-64, Preference for Privately Owned U.S.-Flagged Commercial
Vessels (46 U.S.C. 1241) (flow down not required for subcontracts
awarded beginning May 1, 1996).
(d) The Contractor shall include the terms of this clause, including this
paragraph (d), in subcontracts awarded under this contract.
22
PART III
SECTION J - LIST OF ATTACHMENTS
The following documents are attached and incorporated in this contract:
I. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type
Contracts, NIH(RC)-1 (5/97), 4 pages.
II. Annual Technical Progress Report Format for Each Study, (7/94), 1 page.
III. Safety and Health (Deviation), PHSAR Clause 352.223-70, (8/97), 1 page.
IV. Privacy Act System of Records No. 09-25-0200, (4/97), 3 pages.
V. Small Business Subcontracting Plan, dated 10/18/99, 7 pages.
23
PART IV
SECTION K - REPRESENTATIONS AND CERTIFICATIONS
The following documents are incorporated by reference in this contract:
1. Representations and Certifications, dated February 8, 1999.
24
INVOICE/FINANCING REQUEST INSTRUCTIONS
FOR NIH COST-REIMBURSEMENT TYPE CONTRACTS, NIH(RC)-1
GENERAL: The contractor shall submit claims for reimbursement in the manner and
format described herein and as illustrated in the sample invoice/financing
request.
FORMAT: Standard Form 1034, "Public Voucher for Purchases and Services Other
Than Personal," and Standard Form 1035, "Public Voucher for Purchases and
Services Other Than Personal-- Continuation Sheet," or reproduced copies of such
forms marked ORIGINAL should be used to submit claims for reimbursement. In lieu
of SF-1034 and SF-1035, claims may be submitted on the payee's letter-head or
self-designed form provided that it contains the information shown on the sample
invoice/financing request.
NUMBER OF COPIES: As indicated in the Invoice Submission Clause in the contract.
FREQUENCY: Invoices/financing requests submitted in accordance with the Payment
Clause shall be submitted monthly unless otherwise authorized by the contracting
officer.
COST INCURRENCE PERIOD: Costs incurred must be within the contract performance
period or covered by precontract cost provisions.
BILLING OF COSTS INCURRED: If billed costs include: (1) costs of a prior billing
period, but not previously billed; or (2) costs incurred during the contract
period and claimed after the contract period has expired, the amount and
month(s) in which such costs were incurred shall be cited.
CONTRACTOR'S FISCAL YEAR: Invoices/financing requests shall be prepared in such
a manner that costs claimed can be identified with the contractor's fiscal year.
CURRENCY: All NIH contracts are expressed in United States dollars. When
payments are made in a currency other than United States dollars, xxxxxxxx on
the contract shall be expressed, and payment by the United States Government
shall be made, in that other currency at amounts coincident with actual costs
incurred. Currency fluctuations may not be a basis of gain or loss to the
contractor. Notwithstanding the above, the total of all invoices paid under this
contract may not exceed the United States dollars authorized.
COSTS REQUIRING PRIOR APPROVAL: Costs requiring the contracting officer's
approval, which are not set forth in an Advance Understanding in the contract
shall be so identified and reference the Contracting Officer's Authorization
(COA) Number. In addition, any cost set forth in an Advance Understanding shall
be shown as a separate line item on the request.
INVOICE/FINANCING REQUEST IDENTIFICATION: Each invoice/financing request shall
be identified as either:
(a) INTERIM INVOICE/CONTRACT FINANCING REQUEST -- These are interim payment
requests submitted during the contract performance period.
(b) COMPLETION INVOICE -- The completion invoice is submitted promptly upon
completion of the work; but no later than one year from the contract
completion date, or within 120 days after settlement of the final indirect
cost rates covering the year in which this contract is physically complete
(whichever date is later). The completion invoice should be submitted when
all costs have been assigned to the contract and all performance
provisions have been completed.
(c) FINAL INVOICE -- A final invoice may be required after the amounts owed
have been settled between the Government and the contractor (e.g.,
resolution of all suspensions and audit exceptions).
PREPARATION AND ITEMIZATION OF THE INVOICE/FINANCING REQUEST: The contractor
shall furnish the information set forth in the explanatory notes below. These
notes are keyed to the entries on the sample invoice/financing request.
ATTACHMENT I
Page 1
(a) DESIGNATED BILLING OFFICE NAME AND ADDRESS -- Enter the designated billing
office name and address, identified in the Invoice Submission Clause of
the contract, on all copies of the invoice/financing request.
(b) INVOICE/FINANCING REQUEST NUMBER -- Insert the appropriate serial number
of the invoice/financing request.
(c) DATE INVOICE/FINANCING REQUEST PREPARED -- Insert the date the
invoice/financing request is prepared.
(d) CONTRACT NUMBER AND DATE -- Insert the contract number and the effective
date of the contract.
(e) PAYEE'S NAME AND ADDRESS -- Show the contractor's name (as it appears in
the contract), correct address, and the title and phone number of the
responsible official to whom payment is to be sent. When an approved
assignment has been made by the contractor, or a different payee has been
designated, then insert the name and address of the payee instead of the
contractor.
(f) TOTAL ESTIMATED COST OF CONTRACT -- Insert the total estimated cost of the
contract, exclusive of fixed-fee. For incrementally funded contracts,
enter the amount currently obligated and available for payment.
(g) TOTAL FIXED-FEE -- Insert the total fixed-fee (where applicable). For
incrementally funded contracts, enter the amount currently obligated and
available for payment.
(h) BILLING PERIOD -- Insert the beginning and ending dates (month, day, and
year) of the period in which costs were incurred and for which
reimbursement is claimed.
(i) AMOUNT BILLED FOR CURRENT PERIOD -- Insert the amount billed for the major
cost elements, adjustments, and adjusted amounts for the period.
(j) CUMULATIVE AMOUNT FROM INCEPTION -- Insert the cumulative amounts billed
for the major cost elements and adjusted amounts claimed during this
contract.
(k) DIRECT COSTS -- Insert the major cost elements. For each element, consider
the application of the paragraph entitled "Costs Requiring Prior Approval"
on page 1 of these instructions.
(1) DIRECT LABOR -- Include salaries and wages paid (or accrued) for
direct performance of the contract.
(2) FRINGE BENEFITS -- List any fringe benefits applicable to direct
labor and billed as a direct cost. Fringe benefits included in
indirect costs should not be identified here.
(3) ACCOUNTABLE PERSONAL PROPERTY -- Include permanent research
equipment and general purpose equipment having a unit acquisition
cost of $1,000 or more and having an expected service life of more
than two years, and sensitive property regardless of cost (see the
DHHS Contractor's Guide for Control of Government Property). Show
permanent research equipment separate from general purpose
equipment. Prepare and attach Form HHS-565, "Report of Accountable
Property," in accordance with the following instructions:
List each item for which reimbursement is requested. A reference
shall be made to the following (as applicable):
- The item number for the specific piece of equipment listed in
the Property Schedule.
- The COA letter and number, if the equipment is not covered by
the Property Schedule.
- Be preceded by an asterisk (*) if the equipment is below the
approval level.
Further itemization of invoices/financing requests shall only be
required for items having specific limitations set forth in the
contract.
ATTACHMENT I
Page 2
(4) MATERIALS AND SUPPLIES -- Include equipment with unit costs of less
than $1,000 or an expected service life of two years or less, and
consumable material and supplies regardless of amount.
(5) PREMIUM PAY -- List remuneration in excess of the basic hourly rate.
(6) CONSULTANT FEE -- List fees paid to consultants. Identify consultant
by name or category as set forth in the contract's advance
understanding or in the COA letter, as well as the effort (i.e.,
number of hours, days, etc.) and rate being billed.
(7) TRAVEL -- Include domestic and foreign travel. Foreign travel is
travel outside of Canada, the United States and its territories and
possessions. However, for an organization located outside Canada,
the United States and its territories and possessions, foreign
travel means travel outside that country. Foreign travel must be
billed separately from domestic travel.
(8) SUBCONTRACT COSTS -- List subcontractor(s) by name and amount
billed.
(9) OTHER -- List all other direct costs in total unless exceeding
$1,000 in amount. If over $1,000, list cost elements and dollar
amounts separately. If the contract contains restrictions on any
cost element, that cost element must be listed separately.
(l) COST OF MONEY (COM) -- Cite the COM factor and base in effect during the
time the cost was incurred and for which reimbursement is claimed.
(m) INDIRECT COSTS-OVERHEAD -- Identify the cost base, indirect cost rate, and
amount billed for each indirect cost category.
(n) FIXED-FEE EARNED -- Cite the formula or method of computation for the
fixed-fee (if any). The fixed-fee must be claimed as provided for by the
contract.
(o) TOTAL AMOUNTS CLAIMED -- Insert the total amounts claimed for the current
and cumulative periods.
(p) ADJUSTMENTS -- Include amounts conceded by the contractor, outstanding
suspensions, and/or disapprovals subject to appeal.
(q) GRAND TOTALS
THE CONTRACTING OFFICER MAY REQUIRE THE CONTRACTOR TO SUBMIT DETAILED SUPPORT
FOR COSTS CLAIMED ON ONE OR MORE INTERIM INVOICES/FINANCING REQUESTS.
ATTACHMENT I
Page 3
SAMPLE INVOICE/FINANCING REQUEST
(a) Billing Office Name and Address (b) Invoice/Financing Request No.
NATIONAL INSTITUTES OF HEALTH ---------------------------------
National Cancer Institute, RCAB (c) Date Invoice Prepared
EPS, Room
------ ---------------------------------
0000 XXXXXXXXX XXXX MSC (d) Contract No. and Effective Date
--------
Xxxxxxxx, XX 00000- ---------------------------------
---------- (f) Total Estimated Cost of Contract
(e) Payee's Name and Address
---------------------------------
ABC CORPORATION (g) Total Fixed Fee
000 Xxxx Xxxxxx
Xxxxxxxx, X.X.X. zip code ---------------------------------
Attention: Name, Title, and Phone Number
of Official to Whom Payment is Sent
--------------------------------------------------------------------------------
(h) This invoice/financing request represents reimbursable costs from Aug. 1,
1982 through Aug. 31, 1982
--------------------------------------------------------------------------------
(i) Amount Billed (j) Cumulative Amount
for Current Period From Inception
------------------ ---------------------
(k) Direct Costs
(1) Direct Labor $ 3,400 $ 6,800
(2) Fringe Benefits 600 1,200
(3) Accountable Personal Property
(Attach Form HHS-565)
Permanent Research 3,000 6,000
General Purpose 2,000 2,000
(4) Materials and Supplies 2,000 4,000
(5) Premium Pay 100 150
(6) Consultant Fee-Xx. Xxxxx 1 day @ 100 (COA #3) 100 100
(7) Travel (Domestic) 200 200
(Foreign) 200 200
(8) Subcontract Costs -0- -0-
(9) Other -0- -0-
------- -------
Total Direct Costs $11,600 $20,650
(l) Cost of Money (Factor) of (Appropriate Base) 2,400 3,600
(m) Indirect Costs - Overhead
_____% of Direct Labor or Other Base (Formula) 4,000 6,000
(n) Fixed-Fee Earned (Formula) 700 1,400
------- -------
(o) Total Amount Claimed $18,700 $31,650
(p) Adjustments
Outstanding Suspensions (1,700)
-------
(q) Grand Totals $18,700 $29,950
"I certify that all payments requested are for appropriate purposes and in
accordance with the contract."
----------------------------------- ----------------------------------
Name of Official (Title)
ATTACHMENT I
Page 4
ANNUAL TECHNICAL PROGRESS REPORT FORMAT FOR EACH STUDY
Study Title:
Date:
Provide the number of subject enrolled in the study to date according to the
following categories:
AMERICAN BLACK, WHITE,
INDIAN OR ASIAN OR NOT OF NOT OF OTHER
ALASKAN PACIFIC HISPANIC HISPANIC OR
NATIVE ISLANDER ORIGIN HISPANIC ORIGIN UNKNOWN TOTAL
--------- -------- -------- -------- ------- ------- ------
FEMALE
MALE
UNKNOWN
--------- -------- -------- -------- ------- ------- ------
TOTAL
========= ======== ======== ======== ======= ======= ======
Subpopulations of the minority groups should also be reported, using a similar
format.
ATTACHMENT II
PHS 352.223-70 SAFETY AND HEALTH (DEVIATION) (AUGUST 1997)
(a) To help ensure the protection of the life and health of all persons, and
to help prevent damage to property, the Contractor shall comply with all
Federal, State and local laws and regulations applicable to the work being
performed under this contract. These laws are implemented and/or enforced
by the Environmental Protection Agency, Occupational Safety and Health
Administration and other agencies at the Federal, State and local levels
(Federal, State and local regulatory/enforcement agencies).
(b) Further, the Contractor shall take or cause to be taken additional safety
measures as the Contracting Officer in conjunction with the project or
other appropriate officer, determines to be reasonably necessary. If
compliance with these additional safety measures results in an increase or
decrease in the cost or time required for performance of any part of work
under this contract, an equitable adjustment will be made in accordance
with the applicable "Changes" Clause set forth in this contract.
(c) The Contractor shall maintain an accurate record of, and promptly report
to the Contracting Officer, all accidents or incidents resulting in the
exposure of persons to toxic substances, hazardous materials or hazardous
operations; the injury or death of any person; and/or damage to property
incidental to work performed under the contract and all violations for
which the Contractor has been cited by any Federal, State or local
regulatory/enforcement agency. The report shall include a copy of the
notice of violation and the findings of any inquiry or inspection, and an
analysis addressing the impact these violations may have on the work
remaining to be performed. The report shall also state the required
action(s), if any, to be taken to correct any violation(s) noted by the
Federal, State or local regulatory/enforcement agency and the time frame
allowed by the agency to accomplish the necessary corrective action.
(d) If the Contractor fails or refuses to comply promptly with the Federal,
State or local regulatory/enforcement agency's directive(s) regarding any
violation(s) and prescribed corrective action(s), the Contracting Officer
may issue an order stopping all or part of the work until satisfactory
corrective action (as approved by the Federal, State or local
regulatory/enforcement agencies) has been taken and documented to the
Contracting Officer. No part of the time lost due to any stop work order
shall be subject to a claim for extension of time or costs or damages by
the Contractor.
(e) The Contractor shall insert the substance of this clause in each
subcontract involving toxic substances, hazardous materials, or
operations. Compliance with the provisions of this clause by
subcontractors will be the responsibility of the Contractor.
(End of clause)
ATTACHMENT III
FEDERAL REGISTER / VOL. 62, Xx. 00 / Xxxxxx, Xxxxx 0, 0000 / Xxxxxxx 00000
....
09-25-0200
SYSTEM NAME:
Clinical, Epidemiologic and Biometric Studies of the National Institutes
of Health (NIH), HHS/NIH/OD.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Records are located at NIH and Contractor research facilities which
collect or provide research data for this system. Contractors may include, but
are not limited to: Research centers, clinics, hospitals, universities, medical
schools, research institutions/foundations, national associations, commercial
organizations. collaborating State and Federal Government agencies. and
coordinating centers. A current list of sites, including the address of any
Federal Records Center where records from this system may be stored, is
available by writing to the appropriate Coordinator listed under Notification
Procedure.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Adults and/or children who are the subjects of clinical, epidemiologic,
and biometric research studies of the NIH. Individuals with disease. Individuals
who are representative of the general population or of special groups including.
but not limited to: Normal controls, normal volunteers, family members and
relatives; providers of services (e.g., health care and social work): health
care professionals and educators, and demographic sub-groups as applicable, such
as age, sex, ethnicity, race, occupation, geographic location; and groups
exposed to real and/or hypothesized risks (e.g., exposure to biohazardous
microbial agents).
CATEGORIES OF RECORDS IN THE SYSTEM:
The system contains data about individuals as relevant to a particular
research study. Examples include. but are not limited to: Name, study
identification number, address. relevant telephone numbers, Social Security
Number (voluntary), driver's license number, date of birth. weight, height, sex,
race: medical, psychological and dental information, laboratory and diagnostic
testing results; registries: social, economic and demographic data; health
services utilization; insurance and hospital cost data. employers, conditions of
the work environment, exposure to hazardous substances/compounds; information
pertaining to stored biologic specimens (including blood, urine, tissue and
genetic materials), characteristics and activities of health care providers and
educators and trainers (including curriculum vitae); and associated
correspondence.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
"Research and Investigation," "Appointment and Authority of the Directors
of the National Research Institutes." "National Cancer Institute," "National Eye
Institute," "National Heart, Lung and Blood Institute," "National Institute on
Aging." "National Institute on Alcohol Abuse and Alcoholism." "National
Institute on Allergy and Infectious Diseases," "National Institute of Arthritis
and Musculoskeletal and Skin Diseases," "National Institute of Child Health and
Human Development," "National Institute on Deafness and Other Communication
Disorders," "National Institute of Dental Research," "National Institute of
Diabetes, and Digestive and Kidney Diseases," "National Institute of Drug
Abuse." "National Institute of Environmental Health Sciences," "National
Institute of Mental Health." "National Institute of Neurological Disorders and
Stroke." and the "National Center for Human Genome Research," of the Public
Health Service Act. (42 U.S.C. 241, 242. 248. 281. 282. 284. 285a, 285b, 285c,
285d, 285e, 285f, 285g, 285h, 285i, 285j. 2851, 285m, 285n. 2850. 285p. 285q,
287, 000x, 000x, 000x, 000x. xxx 00 X.X.X. 0000.)
PURPOSES
To document, track, monitor and evaluate NIH clinical, epidemiologic and
biometric research activities.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS
AND THE PURPOSES OF SUCH USES:
1. A record may be disclosed for a research purpose, when the Department:
(A) has determined that the use or disclosure does not violate legal or policy
limitations under which the record was provided, collected, or obtained; e.g..
disclosure of alcohol or drug abuse patient records will be made only in
accordance with the restrictions of confidentiality statutes and regulations 42
U.S.C. 241, 42 U.S.C. 290dd-2, 42 CFR part 2, and where applicable, no
disclosures will be made inconsistent with an authorization of confidentiality
under 42 U.S.C. 241 and 42 CFR part 2a: (B) has determined that the research
purpose (1) cannot be reasonably accomplished unless the
Attachment IV
16598 FEDERAL REGISTER / XXX. 00, Xx. 00 / Monday. April 7. 1997 / Notices
record is provided in individually identifiable form, and (2) warrants the risk
to the privacy of the individual that additional exposure of the record might
bring; (C) has required the recipient to (1) establish reasonable
administrative, technical, and physical safeguards to prevent unauthorized use
or disclosure of the record, (2) remove or destroy the information that
identifies the individual at the earliest time at which removal or destruction
can be accomplished consistent with the purpose of the research project, unless
the recipient has presented adequate justification of a research or health
nature for retaining such information, and (3) make no further use or disclosure
of the record except (a) in emergency circumstances affecting the health or
safety of any individual, (b) for use in another research project, under these
same conditions, and with written authorization of the Department, (c) for
disclosure to a property identified person for the purpose of an audit related
to the research project, if information that would enable research subjects to
be identified is removed or destroyed at the earliest opportunity consistent
with the purpose of the audit, or (d) when required by law; and (D) has secured
a written statement attesting to the recipient's understanding of, and
willingness to abide by, these provisions.
2. Disclosure may be made to a Member of Congress or to a Congressional
staff member in response to an inquiry of the Congressional office made at the
written request of the constituent about whom the record is maintained.
3. The Department of Health and Human Services (HHS) may disclose
information from this system of records to the Department of Justice when: (a)
The agency or any component thereof; or (b) any employee of the agency in his or
her official capacity where the Department of Justice has agreed to represent
the employee; or (c) the United States Government, is a party to litigation or
has an interest in such litigation, and by careful review, the agency determines
that the records are both relevant and necessary to the litigation and the use
of such records by the Department of Justice is therefore deemed by the agency
to be for a purpose that is compatible with the purpose for which the agency
collected the records.
4. Disclosure may be made to agency contractors, grantees, experts,
consultants, collaborating researchers, or volunteers who have been engaged by
the agency to assist in the performance of a service related to this system of
records and who need to have access to the records in order to perform the
activity. Recipients shall be required to comply with the requirements of the
Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
5. Information from this system may be disclosed to Federal agencies,
State agencies (including the Motor Vehicle Administration and State vital
statistics offices, private agencies, and other third parties (such as current
or prior employers, acquaintances, relatives), when necessary to obtain
information on morbidity and mortality experiences and to locate individuals for
follow-up studies. Social Security numbers, date of birth and other identifiers
may be disclosed: (1) To the National Center for Health Statistics to ascertain
vital status through the National Death Index; (2) to the Health Care Financing
Agency to ascertain morbidities; and (3) to the Social Security Administration
to ascertain disabilities and/or location of participants. Social Security
numbers may also be given to other Federal agencies, and State and local
agencies when necessary to locating individuals for participation in follow-up
studies.
6. Medical information may be disclosed in identifiable form to tumor
registries for maintenance of health statistics, e.g., for use in epidemiologic
studies.
7.(a). PHS may inform the sexual and/or needle-sharing partner(s) of a
subject individual who is infected with the human immunodeficiency virus (HIV)
of their exposure to HIV, under the following circumstances: (1) The information
has been obtained in the course of clinical activities at PHS facilities carried
out by PHS personnel or contractors; (2) The PHS employee or contractor has made
reasonable efforts to counsel and encourage the subject individual to provide
the information to the individual's sexual or needle-sharing partner(s); (3) The
PHS employee or contractor determines that the subject individual is unlikely to
provide the information to the sexual or needle-sharing partner(s) or that the
provision of such information cannot reasonably be verified: and (4) The
notification of the partner(s) is made, whenever possible, by the subject
individual's physician or by a professional counselor and shall follow standard
counseling practices.
(b). PHS may disclose information to State or local public health
departments. to assist in the notification of the subject individual's sexual
and/or needle sharing partner(s), or in the verification that the subject
individual has notified such sexual or needle-sharing partner(s).
8. Certain diseases and conditions, including infectious diseases, may be
reported to appropriate representatives of State or Federal Government as
required by State or Federal law.
9. Disclosure may be made to authorized organizations which provide health
services to subject individuals or provide third-party reimbursement or fiscal
intermediary functions, for the purpose of planning for or providing such
services, billing or collecting third-party reimbursements.
10. The Secretary may disclose information to organizations deemed
qualified to carry out quality assessment, medical audits or utilization
reviews.
11. Disclosure may be made for the purpose of reporting child, elder or
spousal abuse or neglect or any other type of abuse or neglect as required by
State or Federal law.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records may be stored on index cards, file folders, computer tapes and
disks (including optical disks), photography media, microfiche, microfilm, and
audio and video tapes. For certain studies, factual data with study code numbers
are stored on computer tape or disk, while the key to personal identifiers is
stored separately, without factual data, in paper/computer files.
RETRIEVABILITY:
During data collection stages and follow-up, retrieval is by personal
identifier (e.g., name, Social Security Number, medical record or study
identification number, etc.). During the data analysis stage, data are normally
retrieved by the variables of interest (e.g., diagnosis, age, occupation).
SAFEGUARDS:
1. Authorized Users: Access to identifiers and to link files is strictly
limited to the authorized personnel whose duties require such access. Procedures
for determining authorized access to identified data are established as
appropriate for each location. Personnel, including contractor personnel, who
may be so authorized include those directly involved in data collection and in
the design of research studies. e.g., interviewers and interviewer supervisors;
project managers; and statisticians involved in designing sampling plans. Other
one-time and special access by other employees is granted on a need-to-know
basis as specifically authorized by the system manager.
Attachment IV
FEDERAL REGISTER / Xxx. 00, Xx. 00 / Monday, April 7, 1997 / Notices 16599
Researchers authorized to conduct research on biologic specimens will
typically access the system through the use of encrypted identifiers sufficient
to link individuals with records in such a manner that does not compromise
confidentiality of the individual.
2. Physical Safeguards: Records are either stored in locked rooms during
off-duty hours, locked file cabinets, and/or secured computer facilities. For
certain studies, personal identifiers and link files are separated and stored in
locked files. Computer data access is limited through the use of key words known
only to authorized personnel.
3. Procedural Safeguards: Collection and maintenance of data is consistent
with legislation and regulations in the protection of human subjects, informed
consent, confidentiality, and confidentiality specific to drug and alcohol abuse
patients where these apply. When anonymous data is provided to research
scientists for analysis, study numbers which can be matched to personal
identifiers will be eliminated, scrambled, or replaced by the agency or
contractor with random numbers which cannot be matched. Contractors who maintain
records in this system are instructed to make no further disclosure of the
records. Privacy Act requirements are specifically included in contracts for
survey and research activities related to this system. The OHS project
directors, contract officers, and project officers oversee compliance with these
requirements. Personnel having access are trained in Privacy Act requirements.
Depending upon the sensitivity of the information in the record, additional
safeguard measures may be employed.
4. Implementation Guidelines: DHHS Chapter 45-13 and supplementary Chapter
PHS.hf: 45-13 of the HHS General Administration Manual and Part 6. "ADP System
Security" of the HHS ADP Systems Security Manual.
RETENTION AND DISPOSAL:
Records are retained and disposed of under the authority of the NIH
Records Control Schedule contained in NIH Manual Chapter 1743, Appendix 1 -
"Keeping and Destroying Records" (HHS Records Management Manual. Appendix
B-361), item 3000-G-3, which allows records to be kept as long as they are
useful in scientific research. Collaborative Perinatal Project records are
retained in accordance with item 3000-G-4, which does not allow records to be
destroyed. Xxxxxxx X. Xxxxx Clinical Research Program medical records (Saint
Elizabeths Hospital. NIMH) are retained for 5 years after last discharge or upon
death of a patient and then transferred to the Washington National Records
Center, where they are retained until 30 years after discharge or death. Refer
to the NIH Manual Chapter for specific conditions on disposal or retention
instructions.
....
DHHS SMALL, SMALL DISADVANTAGED, HUBZone AND WOMAN-OWNED
SMALL BUSINESS SUBCONTRACTING PLAN
DATE OF PLAN: 8/16/99
--------
CONTRACTOR: Gen-Probe Incorporated
---------------------------------------------------------------------
ADDRESS: 10210 Genetic Center Drive
------------------------------------------------------------------------
Xxx Xxxxx, Xxxxxxxxxx 00000
--------------------------------------------------------------------------------
XXXX & BRADSTREET NUMBER:
-------------------------------------------------------
SOLICITATION OR CONTRACT NUMBER: RFP NHLBI-HB-99-10
------------------------------------------------
ITEM/SERVICE (Description): Refinement of New Assays for Direct Detection of
----------------------------------------------------
Nucleic Acids in Donated Organs
--------------------------------------------------------------------------------
TOTAL CONTRACT AMOUNT (Breakout Options): $ 7,583,879 $
------------------ ----------------
Base year or Option #1
Multi-year amount (If applicable)
$ $ $
---------------------- ---------------------- -----------------------------
Option #2 Option #3 Option #4
(If applicable) (If applicable) (If applicable)
TOTAL MODIFICATION AMOUNT, IF APPLICABLE $
----------------------------------
TOTAL TASK ORDER AMOUNT, IF APPLICABLE $
----------------------------------
PERIOD OF CONTRACT PERFORMANCE (Month, Day & Year): 10/01/99 - 9/30/02
------------------
The following is a suggested model for use when developing subcontracting plans
as required by P.L. 95-507 and implemented by Federal Acquisition Regulations
(FAR) Subpart 19.7. While this model plan has been designed to be consistent
with statutory and regulatory requirements, other formats of a subcontracting
plan may be acceptable; however, failure to include the essential information as
exemplified in this model may be cause for either a delay in acceptance or the
rejection of a bid or offer when a subcontracting plan is required. Further, the
use of this model is not intended to waive other requirements that may be
applicable under statute or regulation. "SUBCONTRACT," as used in this clause,
means any agreement (other than one involving an employer-employee relationship)
entered into by a federal Government prime contractor or subcontractor calling
for supplies or services required for performance of the contract or
subcontract.
ATTACHMENT V
1. TYPE OF PLAN (check one)
[X] Individual plan (all elements developed specifically for this contract
and applicable for the full term of this contract)
[ ] Master plan (goals developed for this contract; all other elements
standardized and approved by a lead agency Federal Official; must be
renewed every three years and contractor must provide copy of lead agency
approval)
[ ] Commercial product/service plan (contractor sells large quantities of
off-the shelf commodities to many Government agencies. Plans/goals
negotiated on a company, division, plant or product line basis reflecting
projected annual sales for commercial and non-commercial items. Must be
renewed annually and contractor must provide copy of lead agency approval).
2. GOALS
State separate dollar and percentage goals for Small Business (SB), Small
Disadvantaged Business (SDB), Woman-owned Small Business (WOSB), Historically
Underutilized Business Zone (HUBZone) and "Other@ than small business (OTHER) as
subcontractors, for the base year and each option year, as specified in FAR
19.704 (break out and append option year goals, if applicable) or project annual
subcontracting base and goals under commercial plans.
a. Total estimated dollar value of ALL planned subcontracting i.e., with
ALL types of concerns under this contract is $2,160,787
b. Total estimated dollar value and percent of planned subcontracting with
SMALL BUSINESSES (including SDB, WOSB and HUBZone): (% of "a") $450,500
and 20.8%
c. Total estimated dollar value and percent of planned subcontracting with
SMALL DISADVANTAGED BUSINESSES: (% of "a") $78,350 and 3.6%
d. Total estimated dollar value and percent of planned subcontracting with
WOMAN-OWNED SMALL BUSINESSES: (% of "a") $85,875 and 4.0%
e. Total estimated dollar and percent of planned subcontracting with
HUBZone SMALL BUSINESSES: (% of "a") $0 and 0%
f. Total estimated dollar and percent of planned subcontracting with OTHER
THAN SMALL BUSINESSES: (% of "a") $1,710,287 and 79.2%
2
Provide a description of ALL the products and/or services, to be subcontracted
under this contract, and indicate the size and type of business supplying them
[i.e. (OTHER), (SB), (SDB), (WOSB), (HUBZone)].
TYPE OF BUSINESS (Check all that Apply)
---------------------------------------------------------------------------------------
Subcontracting Product/Service Other SB SDB WOSB HUBZone
---------------------------------------------------------------------------------------
Westat, Inc. X
---------------------------------------------------------------------------------------
Travel X
---------------------------------------------------------------------------------------
Specimen X X
---------------------------------------------------------------------------------------
Materials X X X X
---------------------------------------------------------------------------------------
Cleaning X X X X
---------------------------------------------------------------------------------------
g. Provide a description of the method used to develop the subcontracting goals
for small, small disadvantaged, woman-owned and HUBZone small businesses
concerns. Address efforts made to ensure that maximum practicable subcontracting
opportunities have been made available for those concerns and explain the method
used to identify potential sources for solicitation purposes. Explain the method
and state the quantitative basis (in dollars) used to establish the percentage
goals. Also, explain how the areas to be subcontracted to small, small
disadvantaged, woman-owned and HUBZone small business concerns were determined
and how the capabilities of these concerns were considered for subcontract
opportunities. Identify any source lists or other resources used in the
determination process. (attach additional sheets, if necessary)
Goals were based on use of current and projected vendors, clinical trials,
materials, specimens. cleaning and other. A thorough analysis of existing
vendors will be conducted and where prices or services are competitive we will
select SDB and WOSB. New SDB and WOSB vendors will be sought on advise from the
Small Business Administration in San Diego and in California.
h. Indirect costs have [ ] have not [X] been included in the dollar and
percentage subcontracting goals above. (check one)
i. If indirect costs have been included, explain the method used to determine
the proportionate share of such costs to be allocated as subcontracts to
small, small disadvantaged, woman-owned, and HUBZone small business
concerns.
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3. PROGRAM ADMINISTRATOR:
NAME/TITLE: Xxxx Xxxxxxxx, Purchasing Manager
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ADDRESS: 00000 Xxxxxxx Xxxxxx Xxxxx, Xxx Xxxxx, XX 00000
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TELEPHONE/E-MAIL: (000) 000-0000
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DUTIES: Has general overall responsibility for the company's subcontracting
program, i.e., developing, preparing, and executing subcontracting plans and
monitoring performance relative to the requirements of those subcontracting
plans. Other duties include, but are not limited to, the following activities:
a. Developing and promoting company-wide policy initiatives that
demonstrate the company's support for awarding contracts and
subcontracts to small, small disadvantaged, woman-owned and HUBZone
small business concerns; and for assuring that these concerns are
included on the source lists for solicitations for products and
services they are capable of providing.
b. Developing and maintaining bidder source lists of small, small
disadvantaged, woman-owned and HUBZone small business concerns from
all possible sources;
c. Ensuring periodic rotation of potential subcontractors on bidder's
lists;
d. Ensuring that requests for contracts (RFC) are designed to permit
the maximum practicable participation of small, small disadvantaged,
woman-owned and HUBZone small businesses;
e. Accessing various sources for the identification of small, small
disadvantaged, woman-owned and HUBZone small businesses concerns to
include the SBA's PRONET System, the Federal Acquisition Computer
Network (FACNET) Contractor Registration Data Base, the National
Minority Purchasing Council Vendor Information Service, the Office
of Minority Business Data Center in the Department of Commerce,
local small business and minority associations, contact with local
xxxxxxxx of commerce and Federal agencies' Small Business Offices;
f. Establishing and maintaining contract and subcontract award records;
g. Participating in Business Opportunity Workshops, Minority Business
Enterprise Seminars, Trade Fairs, Procurement Conferences, etc;
h. Ensuring that small, small disadvantaged, woman-owned and HUBZone
small business concerns are made aware of subcontracting
opportunities and assisting concerns in preparing responsive bids to
the company;
i. Conducting or arranging for the conduct of training for purchasing
personnel regarding the intent and impact of Public Law 95-507 on
purchasing;
j. Monitoring the company's subcontracting program performance and
making any adjustments necessary to achieve the subcontract plan
goals;
k. Preparing, and submitting timely, required subcontract reports;
l. Coordinating the company's activities during the conduct of
compliance reviews by Federal agencies, and;
m. Other duties:
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4. Equitable Opportunity
Describe efforts the offeror will make to ensure that small, small
disadvantaged, woman-owned and HUBZone small business concerns will have an
equitable opportunity to compete for subcontracts. These efforts include, but
are not limited to, the following activities:
a. Outreach efforts to obtain sources:
1) Contacting minority and small business trade associations; 2)
Contacting business development organizations and local xxxxxxxx
of commerce; 3) Attending small, small disadvantaged, woman-owned
and HUBZone small business procurement conferences and trade fairs;
4) Requesting sources from the Small Business Administrations (SBA)
PRONET, and other SBA resources, and; 5) Conducting market surveys
to identify new sources.
b. Internal efforts to guide and encourage purchasing personnel:
1) Conducting workshops, seminars, and training programs; 2)
Establishing, maintaining, and utilizing small, small disadvantaged,
and woman-owned and HUBZone small business source lists, guides, and
other data for soliciting subcontractors, and; 3) Monitoring
activities to evaluate compliance with the subcontracting plan.
c. Additional efforts:
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5. Flow Down Clause
The contractor agrees to include the provisions under FAR 52.219-8,
"Utilization of Small, Small Disadvantaged, and Women-Owned Small Business
Concerns", in all subcontracts that offer further subcontracting
opportunities. All subcontractors, except small business concerns, that
receive subcontracts in excess of $500,000 ($1,000,000 for construction)
must adopt and comply with a plan similar to the plan required by FAR
52.219-9, "Small, Small Disadvantaged, and Women-Owned Small Business
Subcontracting Plan." (FAR 19.704(a)(4)).
6. Reporting and Cooperation
The contractor gives assurance of (1) cooperation in any studies or
surveys that may be required; (2) submission of periodic reports which
show compliance with the subcontracting plan; (3) Submission of Standard
Form (SF) 294, "Subcontracting Report for Individual Contracts," and
attendant Optional Form 312, SDB Participation Report and SF-295, "Summary
Subcontract Report," in accordance with the instructions on the forms; and
(4) ensuring that subcontractors agree to submit Standard Forms 294 and
95.
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Reporting Period Report Due Due Date
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Oct 1 - Mar 31 SF-294/of 312 4/30
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Apr 1 - Sept 30 SF-294/of 312 10/30
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Oct 1 - Sept 30 SF-295 10/30
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Special instructions for commercial products plan: SF295 Report is due on
10/30 each year for the previous fiscal year ended 9/30.
5
(a) Submit SF-294 and attendant of Form 312 to: cognizant Contracting
Officer
(b) Submit SF-295 to cognizant contracting officer and to the:
Office of Small and Disadvantaged Business Utilization
Department of Health and Human Services
000 Xxxxxxxxxxxx Xxxxxx, XX
Xxxxxxxx H. Building, Room 517-D
Washington, D.C. 20201
(c) Submit "info" copy to SBA Commercial Market Representative (CMR); call
SBA at 202/205-6475 to locate CMR.
7. Record keeping
The following is a recitation of the types of records the contractor will
maintain to demonstrate the procedures adopted to comply with the
requirements and goals in the subcontracting plan. These records will
include, but not be limited to, the following:
a. Small, small disadvantaged, woman-owned and HUBZone small businesses
source lists, guides and other data identifying such vendors;
b. Organizations contacted in an attempt to locate small, small
disadvantaged, and woman-owned and HUBZone small business sources;
c. On a contract-by-contract basis, records on all subcontract
solicitations over $100,000, which indicate for each solicitation (1)
whether small business concerns were solicited, and, if not; (2) whether
small disadvantaged business concerns were solicited, if not, why not; (3)
whether woman-owned small business concerns were solicited, and if not,
why not; and (4) whether HUBZone small business concerns were solicited,
if not, why not and (5) the reason for the failure of solicited small,
small disadvantaged, and woman-owned and HUBZone small business concerns
to receive the subcontract award;
d. Records to support other outreach efforts, e.g., contracts with
minority and small business trade associations, attendance at small and
minority business procurement conferences and trade fairs;
e. Records to support internal guidance and encouragement provided to
buyers through (1) workshops, seminars, training programs, incentive
awards; and (2) monitoring performance to evaluate compliance with the
program & requirements, and;
f. On a contract-by-contract basis, records to support subcontract award
data including the name address, and business type and size of each
subcontractor. (This item is not required for company or division-wide
commercial products plans.)
g. Additional records:
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REVISED OCTOBER 1998
6
SIGNATURE PAGE
(If applicable)
THIS SUBCONTRACTING PLAN WAS SUBMITTED BY:
CONTRACTOR: GEN-PROBE INCORPORATED
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CONTRACTOR SIGNATURE: /s/ XXXXX XXXXXX
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TYPED SIGNATURE: XXXXX XXXXXX
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TITLE: CHIEF FINANCIAL OFFICER
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DATE PREPARED: AUGUST 16, 1999
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THIS PLAN (CHECK ONE)
[X] INDIVIDUAL [ ] MASTER [ ] COMMERCIAL
IS ACCEPTED BY:
FEDERAL AGENCY: DEPARTMENT OF HEALTH & HUMAN
SERVICES/NIH/NHLBI
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FEDERAL CONTRACTING OFFICER SIGNATURE: SEE BELOW.
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TYPED NAME: XXXXX X. XXXXXXXX
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DATE: /s/ XXXXX X. XXXXXXXX 8/27/99
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