Award Contract for Development and Testing of Vaccines Against Anthrax - National Institutes of Health and VaxGen Inc.
OMB Approval 2700-0042
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1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES
AWARD/CONTRACT UNDER DPAS (15 CFR 350) > N/A 1 20
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2. CONTRACT (Proc. Inst. Ident.) NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
N01-AI-25494 September 30, 2002 CR025
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5. ISSUED BY CODE 2668-25494 6. ADMINISTERED BY (If other than Item 6) CODE
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National Institutes of Health
Contract Management Branch, NIAID DMID-CR
Room 2230 RFP NIH-NIAID-DMID-02-26
6700-B Rockledge Dr., MSC 7612
Bethesda, Maryland 20892-7612
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7. NAME AND ADDRESS OF CONTRACTOR (No. street, county, state and ZIP Code) 8. DELIVERY
|_| FOB ORIGIN |X| OTHER (See below)
FOB Destination
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VaxGen, Inc. 9/ DISCOUNT FOR PROMPT PAYMENT
1000 Marina Blvd., Ste. 200 N/A
Brisbane, CA 94005-1841
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10. SUBMIT INVOICES ITEM
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CODE FACILITY CODE ADDRESS SHOWN IN: Art. G.3
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11. SHIP TO/MARK FOR CODE N/A 12. PAYMENT WILL BE MADE BY CODE N/A
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Article F.2. See Article G.3
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13. AUTHORITY FOR USING OTHER FULL AND OPEN COMPETITION: 14. ACCOUNTING AND APPROPRIATION DATA
EIN 1-943236309-A1 CAN 2-8426401 $ 1,830,548
|_| 10 U.S.C. 2304(c)( ) |_| 41 U.S.C. 253(c)( ) SOCC 25.55 DOC #300N1AI25494A
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15A. ITEM NO. 15B. SUPPLIES/SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT
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Milestone 1 FY 02 $ 550,842
Title: Development and Testing of Vaccines Against Anthrax Milestone 2 FY 03 $ 2,007,593
Period: September 30, 2002 - December 31, 2003 Milestone 3 FY 03 $ 5,059,292
Amount Allotted: $1,830,548 Milestone 4 FY 03 $ 4,812,400
Contract Type: Cost Plus Fixed Fee/Completion Milestone 5 FY 03 $ 1,205,649
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15G. TOTAL AMOUNT OF CONTRACT > $13,635,776
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16. TABLE OF CONTENTS
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(|X|) SEC. DESCRIPTION PAGE(S) (|X| 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 14
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|X| B SUPPLIES OR SERVICES AND PRICE/COST 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
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|X| C DESCRIPTION/SPECS./WORK STATEMENT 4 |X| J LIST OF ATTACHMENTS 19
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|X| D PACKAGING AND MARKING 5 PART IV - REPRESENTATIONS AND INSTRUCTIONS
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|X| E INSPECTION AND ACCEPTANCE 6 |X| K REPRESENTATIONS, CERTIFICATIONS 20
--------------------------------------------------------- AND OTHER STATEMENTS OF OFFERORS
|X| F DELIVERIES OR PERFORMANCE 6
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|X| G CONTRACT ADMINISTRATION DATA 7 |_| L INSTRS., CONDS., AND NOTICES TO OFFERORS
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|X| H SPECIAL CONTRACT REQUIREMENTS 10 |_| 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 18. |_| AWARD (Contractor is not required to sign this
required to sign this document and return __3__ copies to document.) Your offer on Solicitation
issuing office.) Contractor agrees to furnish and deliver all Number______________________, including the additions or changes
items or perform all the services set forth or otherwise made by you which additions or changes are set forth in full
identified above and on any continuation sheets for the above, is hereby accepted as to the items listed above and on
consideration stated herein. The rights and obligations of the any continuation sheets. This award consummates the contract
parties to this contract shall be subject to and governed by the which consists of the following documents: (a) the Government's
following documents: (a) this award/contract, (b) the solicitation and your offer, and (b) this award/contract. No
solicitation, if any, and (c) such provisions, representations, further contractual document is necessary.
certifications, and specifications, as are 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
Thomas P. Hastings, Contracting Officer
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19B. NAME OF CONTRACTOR 19C. DATE SIGNED 20B. UNITED STATES OF AMERICA 20C. DATE SIGNED
________________________________________________ BY ___________________________________________
(Signature of person authorized to sign) (Signature of Contracting Officer)
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NSN 7540-01-152-8069 26-107 STANDARD FORM 26
(REV. 4-85)
PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA
FAR (48 CFR) 53.214(a)
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Contract No. N01-AI-25494
DETAILED TABLE OF CONTRACT CONTENTS
PART I - THE SCHEDULE
SECTION A - SOLICITATION/CONTRACT FORM
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The purpose of this contract is for Development and Testing of Vaccines against
Anthrax.
ARTICLE B.2. ESTIMATED COST AND FIXED FEE
a. The estimated cost of Part A of this contract is $12,625,719.
b. The fixed fee for Part A of this contract is $1,010,057. The fixed fee
shall be paid in installments based on the percentage of completion of
work, as determined by the Contracting Officer, and subject to the
withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED
FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of
this contract. Payment of fixed fee shall not be made in less than monthly
increments.
c. The Government's obligation, represented by the sum of the estimated cost
plus the fixed fee for Part A is $13,635,776.
d. If the Government exercises its option pursuant to ARTICLE H.11. of this
contract, the Government's total obligation represented by the sum of the
estimated cost plus the fixed fee will be increased as follows:
Estimated Cost Fixed Fee Estimated Cost Plus Fixed Fee
$12,555,389 $1,004,432 $13,559,821
e. Total funds currently available for payment and allotted to this contract
are $1,830,548 of which $1,694,952 represents the estimated costs, and of
which $135,596 represents the fixed fee. For further provisions on
funding, see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE
I.2. Authorized Substitutions of Clauses.
f. It is estimated that the amount currently allotted will cover performance
of the contract through December 31, 2002.
g. The Contracting Officer may allot additional funds to the contract without
the concurrence of the Contractor.
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
a. Items Unallowable Unless Otherwise Provided
Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE,
incorporated in this contract, unless authorized in writing by the
Contracting Officer, the costs of the following items or activities shall
be unallowable as direct costs:
(1) Acquisition, by purchase or lease, of any interest in real property;
(2) Special rearrangement or alteration of facilities;
(3) Purchase or lease of any item of general purpose office furniture or
office equipment regardless of dollar value. (General purpose
equipment is defined as any items of personal property which are
usable for purposes other than research, such as office equipment
and furnishings, pocket calculators, etc.);
(4) Travel to attend general scientific meetings;
(5) Foreign travel - See Article B.3.b.(2);
(6) Consultant costs;
(7) Subcontracts;
(8) 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
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Contract No. N01-AI-25494
(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 $144,763
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 six 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.
1. Subcontract
To negotiate a cost-reimbursement type subcontract with Battelle, Inc. for
an amount not to exceed $4,466,225. Award of the subcontract shall not
proceed without the prior written consent of the Contracting Officer after
review of the draft subcontract. After written consent of the subcontract
by the Contracting Officer, a copy of the signed, approved subcontract
shall be provided to the Contracting Officer. The subcontract shall
require that the subcontractor's invoices contain a minimum of the same
detail of the Prime contractor as set forth in attachment 2, NIH(RC)-4.
2. Confidential Treatment of Sensitive Information
The Contractor shall guarantee strict confidentiality of the
information/data that it is provided by the Government during the
performance of the contract. The Government has determined that the
information/data that the Contractor will be provided during the
performance of the contract is of a sensitive nature and can not be
disclosed in any manner.
Disclosure of the information/data, in whole or in part, by the Contractor
can only be made after the Contractor receives prior written approval from
the Contracting Officer. Whenever the Contractor is uncertain with regard
to the proper handling of information/data under the contract, the
Contractor shall obtain a written determination from the Contracting
Officer.
3. Indirect Costs
The proposed overhead rate of [*] and G&A rate of [*] were used for
negotiation purposes only. Provisional overhead and G&A rates shall not be
reimbursed unless and until a formal rate agreement has been executed
between VaxGen, Inc. and the NIH Division of Financial Advisory Services.
4. The following persons shall furnish the amount of time specified below in
direct performance of this contract at no direct cost to this contract or
any other U.S. Government contract, grant or cooperative agreement.
Name Position Effort Duration
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Lance Gordon CEO, VaxGen Inc. 10% 09/30/02 - 12/31/03
Donald Francis President, VaxGen Inc. 7% 09/30/02 - 12/31/03
[*] Denotes confidential treatment requested. A complete version of this exhibit
has been filed separately with the Securities and Exchange Commission.
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Contract No. N01-AI-25494
5. It is the intention of the NIAID to convene an independent Blue Ribbon
Panel composed of ad hoc experts and Government personnel that will advise
the Institute on the selection of the contractor who will be performing
Option Part B of this Statement of Work. This Panel will base its
evaluation on all items delivered under this contract as specified in the
Statement of Work and the Reporting Requirements included in the contract,
and any other materials the contractor may submit to assist in the
evaluation process. Additionally, other information, including but not
limited to evidence of compliance with cGMP requirements, or documentation
necessary for IND preparation, received from other Government sources
(i.e., FDA, CDC, etc.) will also be considered by the Panel in its
evaluation. This evaluation is scheduled to begin shortly after contract
award, and will continue until the selection of a contractor to conduct
Option Part B.
6. In accordance with FAR clause 52.249-6, Termination (Cost-Reimbursement),
any contractor whose technical performance is evaluated by the independent
Blue Ribbon Panel and determined not to have achieved progress towards the
successful completion of the milestones listed in the Statement of Work is
subject to the termination clauses included in this 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, SECTION J, ATTACHMENT 1, dated
9/30/02, attached hereto and made a part of this contract.
ARTICLE C.2. REPORTING REQUIREMENTS
a. Technical Reports
In addition to those reports required by the other terms of this contract,
the Contractor shall prepare and submit the following reports in the
manner stated below and in accordance with ARTICLE F.2. DELIVERIES of this
contract:
(1) Monthly Progress Report
On the first of each month, the Contractor shall submit three
(3) copies of a Monthly Technical Progress Report, comprising
two (2) copies to the Project Officer and one (1) copy to the
Contracting Officer. Such reports shall include the following
specific information:
a. A cover page that lists the contract number and title,
the period of performance being reported, the
contractor's names and address, the author(s), and the
date of submission;
b. SECTION I - An introduction covering the purpose and
scope of the contract effort;
c. SECTION II - The report shall detail, document, and
summarize the results of work done during the period
covered. These reports shall be in sufficient detail to
explain comprehensively the results achieved. The
description shall include pertinent data and/or graphs
in sufficient detail to explain any significant results
achieved and preliminary conclusions resulting from
analysis and scientific evaluation of data accumulated
to date under the project. Also to be included in the
report is a summary of work proposed for the next
reporting period. Specific requirements are set forth in
the Work Statement. A one-page summary of each ongoing
and completed protocol shall be submitted at this time.
A monthly report will not be required for the period
when the final report is due. Preprints and reprints of
papers and abstracts shall be submitted with the Annual
Report.
d. SECTION III - Substantive performance; a description of
current technical or substantive performance and any
problems encountered and/or which may exist along with
proposed corrective action. An explanation of any
difference between planned progress and actual progress,
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Contract No. N01-AI-25494
why the differences have occurred, and if behind planned
progress what corrective steps are planned.
(2) Annual Technical Progress Report for Clinical Research Study
Populations
The Contractor shall submit information about the inclusion of women
and members of minority groups and their subpopulations for each
study being performed under this contract. The contractor shall
submit this information in the format indicated in the attachment
entitled, "Inclusion Enrollment Report," which is set forth in
Section J of this contract. The contractor also shall use this
format, modified to indicate that it is a final report, for
reporting purposes in the final report. The contractor shall submit
the report in accordance with ARTICLE F.1. DELIVERIES of this
contract. In addition, the NIH Policy and Guidelines on the
Inclusion of Women and Minorities as Subjects in Clinical Research,
Amended, October, 2001 applies.
If this contract is for Phase III clinical trials, see II.B of these
guidelines. The Guidelines may be found at the following website:
http://grants.nih.gov/grants/funding/women_min/guidelines_
amended_10_2001.htm
Include a description of the plans to conduct analyses, as
appropriate, by sex/gender and/or racial/ethnic groups in the
clinical trial protocol as approved by the IRB, and provide a
description of the progress in the conduct of these analyses, as
appropriate, in the annual progress report and the final report. If
the analysis reveals no subset differences, a brief statement to
that effect, indicating the subsets analyzed, will suffice. The
Government strongly encourages inclusion of the results of subset
analysis in all publication submissions. In the final report, the
contractor shall include all final analyses of the data on
sex/gender and race/ethnicity.
(3) Final Report
By the expiration date of the contract, the Contractor shall submit
four (4) copies of a comprehensive Final Report, as above,
comprising three (3) copies to the Project Officer and one (1) copy
to the Contracting Officer. This final report shall detail, document
and summarize the results of the entire contract work for the period
covered. This report shall be in sufficient detail to explain
comprehensively the results achieved. Specific requirements are set
forth in the Work Statement. Preprints and reprints not submitted
previously shall be submitted. The Final Report shall be submitted
in accordance with ARTICLE F.1 DELIVERIES of this contract.
(4) Summary of Salient Results
With the annual/final reports the Contractor shall submit a summary
(not to exceed 200 words) of salient results achieved during the
performance of the contract.
b. Other Reports/Deliverables
(1) All milestones indicated in the Statement of Work.
ARTICLE C.3. INVENTION REPORTING REQUIREMENT
All reports and documentation required by FAR CLAUSE 52.227-11 including, but
not limited to, the invention disclosure report, the confirmatory license, and
the government support certification, shall be directed to the Extramural
Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive,
Room 1040-A, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986).
In addition, one copy of the annual utilization report, and a copy of the final
invention statement, shall be submitted to the Contracting Officer at the
address listed below. The final invention statement (see FAR 27.303(a)(2)(ii))
shall be submitted within 90 days after contract expiration to the following
address:
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 contractor name. The
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Contract No. N01-AI-25494
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 SECTION, the Project Officer is the authorized
representative of the Contracting Officer.
c. Inspection and acceptance will be performed at: 6700-B Rockledge Drive,
Room 2230, MSC 7612, Bethesda, MD 20892-7612. (For express mail, please
use Bethesda, MD 20817.)
Acceptance may be presumed unless otherwise indicated in writing by the
Contracting Officer or the duly authorized representative within 30 days
of receipt.
d. This contract incorporates the following clause by reference, with the
same force and effect as if it were given in full text. Upon request, the
Contracting Officer will make its full text available.
FAR Clause No. 52.246-5, INSPECTION OF SERVICES-COST REIMBURSEMENT (APRIL
1984).
FAR Clause No 52.246-8, INSPECTION OF RESEARCH AND DEVELOPMENT - COST
REIMBURSEMENT (MAY 2001).
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. PERIOD OF PERFORMANCE
a. The period of performance of this contract shall be from September 30,
2002 through December 31, 2003.
b. If the Government exercises its option pursuant to Article H.11. of this
contract, the period of performance will be increased as listed below:
Option Part B 1/1/2004 - 12/31/2004
ARTICLE F.2. DELIVERIES
Satisfactory performance of the final contract shall be deemed to occur upon
performance of the work described in Article C.1. and 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.2. 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 dates specified below:
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Item Description Quantity Delivery Schedule
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(a) Monthly Progress Report 3 The 1st day of each month
(b) Annual Technical Progress Report 2 on or before every Sept. 30 beginning in 2003
for Clinical Research Study Populations
(c) Final Report 4 Contract end date
(d) Summary of Salient Results 4 Contract end date
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Contract No. N01-AI-25494
b. The above items shall be addressed and delivered to:
Addressee Deliverable Item No. Quantity
Project Officer (a) 2
(see Article G.1.) (b) 1
(c), (d) 3
Contracting Officer (a), (b), (c), (d) 1
6700-B Rockledge Drive
Room 2230, MSC 7612
Bethesda, MD 20892-7612
For express mail, please use Bethesda, MD 20817
ARTICLE F.3. 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: http://www.arnet.gov/far/.
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
52.242-15, Stop Work Order (AUGUST 1989) with ALTERNATE I (APRIL 1984).
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. PROJECT OFFICER
The following Project Officer will represent the Government for the purpose of
this contract:
Ed Nuzum DVM, PhD
Office of Biodefense Research Affairs (OBRA)
DMID/NIAID/NIH
6700-B Rockledge Drive
Room 3130, MSC 7630
Bethesda, MD 20892-7630
enuzum@niaid.nih.gov
The Project Officer is responsible for: (1) monitoring the Contractor's
technical progress, including the surveillance and assessment of performance and
recommending to the Contracting Officer changes in requirements; (2)
interpreting the Statement of Work and any other technical performance
requirements; (3) performing technical evaluation as required; (4) performing
technical inspections and acceptances required by this contract; and (5)
assisting in the resolution of technical problems encountered during
performance.
The Contracting Officer is the only person with authority to act as agent of the
Government under this contract. Only the Contracting Officer has authority to:
(1) direct or negotiate any changes in the Statement of Work; (2) modify or
extend the period of performance; (3) change the delivery schedule; (4)
authorize reimbursement to the Contractor any costs incurred during the
performance of this contract; or (5) otherwise change any terms and conditions
of this contract.
The Government may unilaterally change its Project Officer designation.
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Contract No. N01-AI-25494
ARTICLE G.2. KEY PERSONNEL
Pursuant to the Key Personnel clause incorporated in this contract, the
following individual is considered to be essential to the work being performed
hereunder:
Name Title
Marc Gurwith, MD Principal Investigator
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
FINANCIAL REPORT
a. Invoice/Financing Request Instructions and Contract Financial Reporting
for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and made
part of this contract. The instructions and the following directions for
the submission of invoices/financing request must be followed to meet the
requirements of a "proper" payment request pursuant to FAR 32.9.
These instructions also provide for the submission of financial and
personnel reporting required by HHSAR 342.7002.
(1) Invoices/financing requests shall be submitted as follows:
An original and two copies to the following designated billing
office:
Contracting Officer
Contract Management Branch, NIAID, NIH
6700-B Rockledge Drive
Room 2230, MSC 7612
Bethesda, MD 20892-7612
For express mail, please use Bethesda, MD 20817
(2) Inquiries regarding payment of invoices should be directed to the
designated billing office, (301) 496-0194.
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.12. of this
contract. For billing purposes, certified invoices are required for the
billing period during which the applicable Fiscal Year funds were
initially charged through the final billing period utilizing the
applicable Fiscal Year funds:
"I hereby certify that the salaries charged in this invoice are in
compliance with P.L. [cite the applicable Public Law Number for the
applicable Fiscal Year as stated in ARTICLE H.12.] and ARTICLE H.12.
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
representative responsible for negotiating provisional and/or final indirect
cost rates is identified as follows:
Director, Division of Financial Advisory Services
Office of Acquisition Management and Policy
National Institutes of Health
6100 Building, Room 6B05
6100 EXECUTIVE BLVD MSC-7540
BETHESDA MD 20892-7540
These rates are hereby incorporated without further action of the Contracting
Officer.
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Contract No. N01-AI-25494
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 Contracts Property
Administrator.
Requests for information regarding property under this contract should be
directed to the following office:
Division of Personal Property Services, NIH
6011Building, Suite 637
6011 EXECUTIVE BLVE MSC 7670
BETHESDA MD 20852-7670
(301) 496-6466
b. Notwithstanding the provisions outlined in the DHHS Publication,
Contractor's Guide for Control of Government Property, 1990 which is
incorporated in this contract in paragraph a. above, the contractor shall
use the form entitled, "Report of Government Owned, Contractor Held
Property" for performing annual inventories required under this contract.
This form is included as an attachment in SECTION J of this contract.
c. Contractor-Acquired Government Property - Schedule I-A
Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this
contract, the Contractor will be authorized to acquire the property listed
in the attached Schedule I-A for use in direct performance of the
contract, following receipt of the Contracting Officer's written approval,
based on contractor-furnished prices and evidence of competition. In
accordance with the clause, GOVERNMENT PROPERTY, ALTERNATE I, title to
equipment having an acquisition cost of less than $5,000 shall vest in the
Contractor, and title to equipment having an acquisition of $5,000 or more
purchased with funds made available under the contract shall vest in the
Contractor subject to the provisions of the clause, GOVERNMENT PROPERTY;
provided that the Government may direct transfer of the title to the
Government or to a third party within twelve months after completion or
termination of the contract. The transfer of title to such equipment to
the Government or to a third party shall not be the basis for any claim
against the Government by the Contractor.
ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
a. Contractor Performance Evaluations
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, an interim evaluation will be prepared during the
performance 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. If agreement cannot be reached
between the parties, the matter 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.
b. Electronic Access to Contractor Performance Evaluations
Contractors that have Internet capability may access evaluations through a
secure Web site for review and comment by completing the registration form
that can be obtained at the following address:
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Contract No. N01-AI-25494
http://ocm.od.nih.gov/cdmp/cps_contractor.htm
The registration process requires the contractor to identify an individual
that will serve as a primary contact and who will be authorized access to
the evaluation for review and comment. In addition, the contractor will be
required to identify an alternate contact who will be responsible for
notifying the cognizant contracting official in the event the primary
contact is unavailable to process the evaluation within the required
30-day time frame.
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. HUMAN SUBJECTS
Research involving human subjects shall not be conducted under this contract
until the protocol developed in Phase I has been approved by the Government,
written notice of such approval has been provided by the Contracting Officer,
and the Contractor has provided to the Contracting Officer a properly completed
Optional Form 310 certifying IRB review and approval of the protocol. The human
subject certification can be met by submission of the Contractor's self
designated form, provided that it contains the information required by the
Optional Form 310.
ARTICLE H.3. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
NIH policy requires education on the protection of human subject participants
for all investigators receiving NIH contract awards for research involving human
subjects. For a complete description of the NIH Policy announcement on required
education in the protection of human subject participants, the contractor should
access the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at
the following website: http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-00-039.html. The information below is a summary of the NIH Policy
Announcement:
The contractor shall maintain the following information: (1) a list of the names
and titles of the principal investigator and any other individuals working under
the contract who are responsible for the design and/or conduct of the research;
(2) the title of the education program(s) in the protection of human subjects
that has been coompleted for each named personnel and; (3) a one sentence
description of the educational program(s) listed in (2) above. This requirement
extends to investigators and all individuals responsible for the design and/or
conduct of the research who are working as subcontractors or consultants under
the contract.
Prior to any substitution of the Principal Investigator or any other individuals
responsible for the design and/or conduct of the research under the contract,
the contractor shall provide the following written information to the
Contracting Officer: the title of the education program and a one sentence
description of the program that has been completed by the replacement.
ARTICLE H.4. DATA AND SAFETY MONITORING IN CLINICAL TRIALS
The contractor is directed to the full text of the NIH Policy regarding Data and
Safety Monitoring and Reporting of Adverse Events, which may be found at the
following web sites:
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Contract No. N01-AI-25494
http://grants.nih.gov/grants/guide/notice-files/not98-084.html
http://grants.nih.gov/grants/guide/notice-files/not99-107.html
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html
The contractor must comply with the NIH Policy cited in these NIH Announcements
and any other data and safety monitoring requirements found elsewhere in this
contract.
Data and Safety Monitoring shall be performed in accordance with the approved
Data and Safety Monitoring Plan.
The Data and Safety Monitoring Plan shall be established and approved prior to
beginning the conduct of the clinical trial.
ARTICLE H.5. HUMAN MATERIALS
The acquisition and supply of all human specimen material (including fetal
material) used under this contract shall 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 no undue inducements,
monetary or otherwise, will be offered to any person to influence their donation
of human material.
ARTICLE H.6. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
a. Pursuant to Public Law(s) 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 is 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. 107-116, Section 510 2002 10/1/01 - 9/30/02
ARTICLE H.7. 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
P.L. 107-116, Section 505 2002 10/1/01 - 9/30/02
ARTICLE H.8. 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 552a) and applicable agency regulations.
Violation of the Act may involve the imposition of criminal penalties.
The Privacy Act System of Records applicable to this project is Number
09-25-0200. This document is incorporated into this contract as Attachment 4.
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Contract No. N01-AI-25494
ARTICLE H.9. INTRODUCTION OF RODENTS AND RODENT PRODUCTS
No rodent or rodent product shall be delivered into the NIH, NIAID environment
(NIH) directly, or through collaborative research or holding facilities under
contract to NIAID except by permit. Direct shipments to NIH from a commercial
colony will be considered exempt. Non-exempt sources must be approved by permit
issued through the National Center for Research Resources (NCRR). The permit
must be obtained by the Contractor prior to the shipment to NIH of the rodents
and/or rodent products. The Contractor must be sure that this permit exists and
is current before transferring rodents or rodent products into the NIH, NIAID
environment. Refusal or negligence to do so will be considered a material breach
of contract and may be treated as any other such material breach. Applications
for permits should be submitted not less than 30 days prior to shipping date to:
NIH Veterinary Resources Branch (VRP), National Center for Research Resources
(NCRR), Scientific Services Branch, Laboratory Sciences Section, Building 28A,
Room 111, 28 LIBRARY DR MSC 5210, BETHESDA MD 20892-5210, (301)496-2527.
ARTICLE H.10. ANIMAL WELFARE ASSURANCE
The Contractor shall obtain, prior to the start of any work under this contract,
an approved Animal Welfare Assurance from the Office of Extramural Research
(OER), Office of Laboratory Animal Welfare (OLAW), Office of the Director, NIH,
as required by Section I-43-30 of the Public Health Service Policy on Humane
Care and Use of Laboratory Animals. The Contractor shall maintain such assurance
for the duration of this contract, and any subcontractors performing work under
this contract involving the use of animals shall also obtain and maintain an
approved Animal Welfare Assurance.
ARTICLE H.11. OPTION PROVISION
Unless the Government exercises its option pursuant to the Option Clause set
forth in ARTICLE I.3., the contract will consist only of Part A of the Statement
of Work as defined in Sections C and F of the contract. Pursuant to clause
52.217-9 set forth in ARTICLE I.3. of this contract, the Government may, by
unilateral contract modification, require the Contractor to perform Part B of
the Statement of Work as also defined in Sections C and F of the contract. If
the Government exercises this option, notice must be given at least 60 days
prior to the expiration date of this contract, and the estimated cost plus fixed
fee of the contract will be increased as set forth in ARTICLE B.2.
ARTICLE H.12. SALARY RATE LIMITATION LEGISLATION PROVISIONS
a. Pursuant to Public Law(s) cited in paragraph b., below, no NIH Fiscal Year
funds 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 covered. Direct salary is exclusive of fringe benefits, overhead, and
general and administrative expenses (also referred to as "indirect cost"
or "facilities and administrative (F&A) costs"). Direct salary has the
same meaning as the term "institutional base salary." An individual's
direct salary (or institutional base salary) is the annual compensation
that the contractor pays for an individual's appointment whether that
individual's time is spent on research, teaching, patient care or other
activities. Direct salary (or institutional base salary) excludes any
income that an individual may be permitted to earn outside of duties to
the contractor. The per year salary rate limit also applies to individuals
proposed under subcontracts. It does not apply to fees paid to
consultants. If this is a multiple 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 HHS appropriation
acts.
b. Public Law No. Fiscal Year Dollar Amount of Salary Limitation
107-116 FY-02 Executive Level I*
c. Direct salaries which will be paid with FY-02 funds are limited to the
Executive Level I rate which was in effect on the date(s) the expense was
incurred.
*Effective 1/1/02, for contract expenditures using FY-02 funds, the Executive
Level I rate is $166,700 and will remain at that level until such time as it is
determined to raise the Executive Schedule annual rates. See the web site listed
below for Executive Schedule rates of pay.
FY-02 EXECUTIVE LEVEL SALARIES: http://www .opm.gov/oca/02tables/ex.pdf
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Contract No. N01-AI-25494
ARTICLE H.13. 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 Institute of Allergy and Infectious Diseases, National
Institutes of Health, under Contract No. N01-AI-25494."
ARTICLE H.14. 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
P.L. 107-116, Section 507 2002 10/1/01 - 9/30/02
ARTICLE H.15. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste
and abuse in NIH funded programs is encouraged to report such matters to the HHS
Inspector General=s Office in writing or on the Inspector General=s Hotline. The
toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be
handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing
address is:
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
P.O. Box 23489
Washington, D.C. 20026
ARTICLE H.16. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES
Unique research resources arising from NIH-funded research are to be shared with
the scientific research community. NIH provides guidance, entitled, ASharing
Biomedical Research Resources: Principles and Guidelines for Recipients of NIH
Research Grants and Contracts,@ (Federal Register Notice, December 23, 1999 [64
FR 72090]), concerning the appropriate terms for disseminating and acquiring
these research resources. This guidance, found at :
http://ott.od.nih.gov/NewPages/64FR72090.pdf. is intended to help contractors
ensure that the conditions they impose and accept on the transfer of research
tools will facilitate further biomedical research, consistent with the
requirements of the Bayh-Dole Act and NIH funding policy.
Note: For the purposes of this Article, the terms, "research tools," "research
materials," and "research resources" are used interchangeably and have the same
meaning.
ARTICLE H.17. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES
The Offeror/Contractor acknowledges that U. S. Executive Orders and Laws,
including but not limited to E.O. 13224 and P.L. 107-56, prohibit transactions
with, and the provision of resources and support to, individuals and
organizations associated with terrorism. It is the legal responsibility of the
contractor to ensure compliance with these Executive Orders and Laws. This
clause must be included in all subcontracts issued under this contract.
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Contract No. N01-AI-25494
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:
http://www.arnet.gov/far/.
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
FAR
CLAUSE NO. DATE TITLE
---------- ---- -----
52.202-1 Dec 2001 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 Aug 2000 Printed or Copied 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
52.216-7 Feb 2002 Allowable Cost and Payment
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Contract No. N01-AI-25494
52.216-8 Mar 1997 Fixed Fee
52.219-8 Oct 2000 Utilization of Small Business Concerns (Over
$100,000)
52.219-9 Jan 2002 Small Business Subcontracting Plan (Over $500,000)
52.219-16 Jan 1999 Liquidated Damages - Subcontracting Plan (Over
$500,000)
52.222-2 Jul 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 Apr 2002 Equal Opportunity
52.222-35 Dec 2001 Equal Opportunity for Special Disabled Veterans,
Veterans of the Vietnam Era, and Other Eligible
Veterans
52.222-36 Jun 1998 Affirmative Action for Workers with Disabilities
52.222-37 Dec 2001 Employment Reports on Special Disabled Veterans,
Veterans of the Vietnam Era, and Other Eligible
Veterans
52.223-6 May 2001 Drug-Free Workplace
52.223-14 Oct 2000 Toxic Chemical Release Reporting
52.225-1 May 2002 Buy American Act - Supplies
52.225-13 Jul 2000 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 "52.227-14
FAR 52.227-16 Jun 1987 Additional Data Requirements
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 Feb 2002 Prompt Payment
52.232-34 May 1999 Payment by Electronic Funds TransferOther Than
Central Contractor Registration
52.233-1 Jul 2002 Disputes
52.233-3 Aug 1996 Protest After Award, Alternate I (Jun 1985)
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Contract No. N01-AI-25494
52.242-1 Apr 1984 Notice of Intent to Disallow Costs
52.242-3 May 2001 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
---------- ---- -----
352.202-1 Jan 2001 Definitions - with Alternate paragraph (h)
(Jan 2001)
352.216-72 Oct 1990 Additional Cost Principles
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 Publications and Publicity
352.270-7 Jan 2001 Paperwork Reduction Act
[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
CONTRACT - Rev. 7/2002].
ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES
ARTICLE I.1. of this SECTION is hereby modified as follows:
ALTERNATE IV (OCTOBER 1997) of FAR Clause 52.215-21, REQUIREMENTS FOR COST OR
PRICING DATA OR INFORMATION OTHER THAN COST OR PRICING DATA--MODIFICATIONS
(OCTOBER 1997) is added.
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Contract No. N01-AI-25494
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 therefore.
Note: When this contract is fully funded, FAR Clause 52.232-22, LIMITATION OF
FUNDS will no longer apply and FAR Clause 52.232-20, LIMITATION OF COST will
become applicable.
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
FAR 52.215-17, Waiver of Facilities Capital Cost of Money (OCTOBER 1997).
FAR 52.217-9, Option to Extend the Term of the Contract (MARCH 2000).
"(a) The Government may extend the term of this contract by written
notice to the Contractor within 15 months; provided that the
Government gives the Contractor a preliminary written notice
of its intent to extend at least 60 days before the contract
expires. The preliminary notice does not commit the Government
to an extension.
(c) The total duration of this contract, including the exercise of
any options under this clause, shall not exceed 27 months."
FAR 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business
Concerns (JANUARY 1999).
"(c) Waiver of evaluation preference.....
|_| Offeror elects to waive the evaluation preference."
FAR 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged
Business Concerns (MAY 2001).
"(b) Evaluation adjustment. (1) The Contracting Officer will
evaluate offers by adding a factor of 0 percent to the price
of all offers.
FAR 52.224-1, Privacy Act Notification (APRIL 1984).
FAR 52.224-2, Privacy Act (APRIL 1984).
Alternate I (JUNE 1987), FAR 52.227-14, Rights in Data--General (JUNE 1987).
Alternate V (JUNE 1987), FAR 52.227-14, Rights in Data--General (JUNE 1987).
Specific data items that are not subject to paragraph (j) include:
none
FAR 52.242-3, Penalties for Unallowable Costs (OCTOBER 1995).
FAR 52.247-63, Preference for U.S. Flag Air Carriers (JANUARY 1997).
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CHAPTER 3) CLAUSES:
(1) HHSAR 352.223-70, Safety and Health (JANUARY 2001).
(2) HHSAR 352.224-70, Confidentiality of Information (APRIL 1984).
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Contract No. N01-AI-25494
(3) HHSAR 352.270-8, Protection of Human Subjects (JANUARY 2001).
Note: The Office for Human Research Protections (OHRP), Office of
the Secretary (OS), Department of Health and Human Services (DHHS)
is the office responsible for oversight of the Protection of Human
subjects and should replace Office for Protection from Research
Risks (OPRR), National Institutes of Health (NIH) wherever it
appears in this clause.
(4) HHSARS 352.270-9, Care of Live Vertebrate Animals (JANUARY 2001).
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).
2. NIH (RC)-11, Research Patient Care Costs (4/1/84).
ARTICLE I.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 1) CLAUSES:
1. FAR Clause 52.244-6, SUBCONTRACTS FOR COMMERCIAL ITEMS (MAY 2002)
(a) Definitions. As used in this clause--
Commercial item, has the meaning contained in the clause at
52.202-1, Definitions.
Subcontract, 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) (1) The Contractor shall insert the following clauses in
subcontracts for commercial items:
(i) 52.219-8, Utilization of Small Business Concerns (OCT
2000) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts
that offer further subcontracting opportunities. If the
subcontract (except subcontracts to small business
concerns) exceeds $500,000 ($1,000,000 for construction
of any public facility), the subcontractor must include
52.219-8 in lower tier subcontracts that offer
subcontracting opportunities.
(ii) 52.222-26, Equal Opportunity (APR 2002) (E.O. 11246).
(iii) 52.222-35, Equal Opportunity for Special Disabled
Veterans, Veterans of the Vietnam Era, and Other
Eligible Veterans (DEC 2001) (38 U.S.C. 4212(a)).
(iv) 52.222-36, Affirmative Action for Workers with
Disabilities (JUN 1998) (29 U.S.C. 793).
(v) 52.247-64, Preference for Privately Owned U.S.-Flag
Commercial Vessels (JUN 2000) (46 U.S.C. Appx 1241)
(flowdown not required for subcontracts awarded
beginning May 1, 1996).
(2) While not required, the Contractor may flow down to
subcontracts for commercial items a minimal number of
additional clauses necessary to satisfy its contractual
obligations.
(d) The Contractor shall include the terms of this clause, including
this paragraph (d), in subcontracts awarded under this contract.
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Contract No. N01-AI-25494
PART III
SECTION J - LIST OF ATTACHMENTS
The following documents are attached and incorporated in this contract:
Statement of Work, dated 9/30/02, 2 pages.
Invoice/Financing Request and Contract Financial Reporting Instructions for NIH
Cost-Reimbursement Type Contracts, NIH(RC)-4, (5/97), 5 pages.
Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01), 1 page.
Privacy Act System of Records, Number 09-25-0200, 6 pages
5. Procurement of Certain Equipment, NIH (RC)-7, 4/1/84, 1 page
6. Research Patient Care Costs, NIH (RC)-11, 4/1/84, 1 page
7. Government Property - Schedule I-A, dated 9/30/02, 1 page.
8. Report of Government Owned, Contractor Held Property, 1 page.
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Contract No. N01-AI-25494
PART IV
SECTION K - REPRESENTATIONS AND CERTIFICATIONS
The following documents are incorporated by reference in this contract:
1. Representations and Certifications, dated 08/27/02.
2. Human Subjects Assurance Identification Number FWA00001083.
3. Animal Welfare Assurance Number subcontractor Battelle A3034-01, expiration
09/30/05.
END of the SCHEDULE
(CONTRACT)
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Contract No. N01-AI-25494
STATEMENT OF WORK
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
work described below. This procurement will be milestone-driven, with periodic
assessment of progress by the NIAID program staff in consultation with the
contractor.
Part A
1. Using intellectual property to which the company has unencumbered
access and technology known to be acceptable in the production of
vaccines licensed for use in the U.S., develop a prototype
recombinant Bacillus anthracis Protective Antigen (PA) vaccine that
will protect against lethal challenge with B. anthracis spores in at
least two appropriate animal models of inhalation anthrax as soon as
possible after the administration of not more than 3 immunizing
doses compatible with post-exposure immunization.
2. Milestone 1: Within three months of award, produce a pilot lot of
recombinant Bacillus anthracis protective antigen (rPA) vaccine
under manufacturing conditions necessary to support the use of this
product under IND and provide doses required for Phase 1 and
Optional Phase 2 clinical trials.
3. Milestone 2: Within six months of award of Part A, provide the NIH
with 2,000 doses of vaccine filled and finished as single doses and
all information and authorization necessary to enable the government
to file an IND for Phase 1 clinical trials, excluding only that
considered to be proprietary, which may be summarized for NIAID and
submitted to the FDA in a separate master file.
4. Milestone 3: Develop and submit for review and approval to NIAID, a
clinical development plan for evaluation of the vaccine, including
protocols for the conduct of Phase 1 and optional Phase 2 clinical
trials. NIAID will oversee development of consensus, standardized
Phase 1 and Phase 2 protocols with participation of successful
awardees to facilitate comparison of serological and safety data to
be derived from trials of the existing licensed anthrax vaccine,
which are commencing in 2002.
For clinical trials conducted by the company under their IND, the
plan must provide information about the contract research
organization (CRO) proposed to conduct the trials, including
information about clinical personnel, laboratory procedures,
proposed sites and timelines for their completion. The plan should
describe the operational procedures the company will follow to
assure adequate oversight of clinical trials, timely and accurate
reporting of information to the FDA, structure and responsibilities
of a data and safety monitoring board, as well as policies of how
data will be processed, shared and published. The plan should
specify how NIAID would be kept apprised of progress and
communications with the FDA, including processes to assure NIAID may
co-monitor or provide for independent audit of the clinical site.
The Government, acting through the CDC, will conduct all serological
assays from samples obtained in Phase 1 and Phase 2 trials using
standardized assays that have been established at the CDC. The CDC
will help establish validated assays in company laboratories by
providing and initial supply of reagents, training and confirmation
of samples assayed in company laboratories.
5. Milestone 4: Upon approval of the Phase 1 Protocol, the contractor
shall conduct Phase 1 Trials.
6. Milestone 5: Within twelve months of award, provide a feasibility
plan to manufacture, formulate, fill and finish, test, and deliver
to the government up to 25 million doses of the candidate rPA
vaccine suitable for storage in a stockpile for emergency use. The
plan should include proposed steps to be taken to monitor the
quality and replenish the stockpile as needed to maintain its ready
availability for emergency use under IND.
The feasibility plan should include: (a) details of the process to
scale-up production, including data to support the approach, i.e.
successful scale-up of similar product class or data from
intermediate scales of production; (b) timeline for production and
delivery of up to 25 million doses of product; (c) strategy that
will be pursued to seek a
Statement of Work ATTACHMENT 1
(9/30/02) Page 1
<PAGE>
Contract No. N01-AI-25494
US license for the product and to provide continued support for
maintaining an active government-held IND; (d) estimates of cost/dose
of up to 25 million doses delivered as single doses to the government
for use, and (e) plan to monitor and replenish the stockpile as
needed in consultation with the managers of the Government stockpile.
MEETINGS AND CONFERENCES
The Contractor shall participate in regular meetings to coordinate and direct
the contract effort as directed by the Project Officer. Such meetings may
include, but are not limited to, meetings of all contractors to discuss clinical
protocol design; and meetings with individual contractors and other PHS
officials to discuss the technical, regulatory and ethical aspects of the
program.
OPTION Part B - Upon approval of the Phase 2 Protocol, the contractor shall
conduct Phase 2 Trials.
Statement of Work ATTACHMENT 1
(9/30/02) Page 2
<PAGE>
Contract No. N01-AI-25494
INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING
INSTRUCTIONS FOR NIH COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4
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: (l) 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, billings 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 C These are interim payment
requests submitted during the contract performance period.
(b) Completion Invoice C 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 C 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.
(a) Designated Billing Office Name and Address C Enter the designated billing
office and address, identified in the Invoice Submission Clause of the
contract, on all copies of the invoice/financing request.
NIH(RC)-4 ATTACHMENT 2
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<PAGE>
Contract No. N01-AI-25494
(b) Invoice/Financing Request Number C Insert the appropriate serial number of
the invoice/financing request.
(c) Date Invoice/Financing Request Prepared C Insert the date the
invoice/financing request is prepared.
(d) Contract Number and Date C Insert the contract number and the effective
date of the contract.
(e) Payee's Name and Address C 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 C 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 C Insert the total fixed-fee (where applicable). For
incrementally funded contracts, enter the amount currently obligated and
available for payment.
(h) Billing Period C 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) Incurred Cost - Current C Insert the amount billed for the major cost
elements, adjustments, and adjusted amounts for the current period.
(j) Incurred Cost - Cumulative C Insert the cumulative amounts billed for the
major cost elements and adjusted amounts claimed during this contract.
(k) Direct Costs C 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.
(l) Direct Labor C Include salaries and wages paid (or accrued) for
direct performance of the contract. For Key Personnel, list each
employee on a separate line. List other employees as one amount
unless otherwise required by the contract.
(2) Fringe Benefits C 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 C 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 Contracting Officer's Authorization 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.
NIH(RC)-4 ATTACHMENT 2
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<PAGE>
Contract No. N01-AI-25494
(4) Materials and Supplies C 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 C List remuneration in excess of the basic hourly rate.
(6) Consultant Fee C 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 C 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 C List subcontractor(s) by name and amount billed.
(9) Other C 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) C 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 C Identify the cost base, indirect cost rate, and
amount billed for each indirect cost category.
(n) Fixed-Fee Earned C 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 C Insert the total amounts claimed for the current
and cumulative periods.
(p) Adjustments C 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.
FINANCIAL REPORTING INSTRUCTIONS:
These instructions are keyed to the Columns on the sample invoice/financing
request.
Column A--Expenditure Category - Enter the expenditure categories required by
the contract.
Column B--Cumulative Percentage of Effort/Hrs.-Negotiated - Enter the percentage
of effort or number of hours agreed to doing contract negotiations for each
employee or labor category listed in Column A.
Column C--Cumulative Percentage of Effort/Hrs.-Actual - Enter the percentage of
effort or number of hours worked by each employee or labor category listed in
Column A.
Column D--Incurred Cost-Current - Enter the costs, which were incurred during
the current period.
Column E--Incurred Cost-Cumulative - Enter the cumulative cost to date.
NIH(RC)-4 ATTACHMENT 2
Rev. 5/97 Page 3
<PAGE>
Contract No. N01-AI-25494
Column F--Cost at Completion - Enter data only when the contractor estimates
that a particular expenditure category will vary from the amount negotiated.
Realistic estimates are essential.
Column G-- Contract Amount - Enter the costs agreed to during contract
negotiations for all expenditure categories listed in Column A.
Column H--Variance (Over or Under) - Show the difference between the estimated
costs at completion (Column F) and negotiated costs (Column G) when entries have
been made in Column F. This column need not be filled in when Column F is blank.
When a line item varies by plus or minus 10 percent, i.e., the percentage
arrived at by dividing Column F by Column G, an explanation of the variance
should be submitted. In the case of an overrun (net negative variance), this
submission shall not be deemed as notice under the Limitation of Cost (Funds)
Clause of the contract.
Modifications: Any modification in the amount negotiated for an item since the
preceding report should be listed in the appropriate cost category.
Expenditures Not Negotiated: An expenditure for an item for which no amount was
negotiated (e.g., at the discretion of the contractor in performance of its
contract) should be listed in the appropriate cost category and all columns
filled in, except for G. Column H will of course show a 100 percent variance and
will be explained along with those identified under H above.
NIH(RC)-4 ATTACHMENT 2
Rev. 5/97 Page 4
<PAGE>
Contract No. N01-AI-25494
SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT
================================================================================
(a) Billing Office Name and Address (b) Invoice/Financing Request
No._____________________________________
NATIONAL INSTITUTES OF HEALTH (c) Date Invoice Prepared_______________
National Institute of Allergy
and Infectious Diseases
Contract Management Branch (d) Contract
6700-B Rockledge Drive No._____________________________________
Room 2230, MSC 7612
Bethesda, MD 20892-7612 Effective Date__________________________
(e) Payee's Name and Address (f) Total Estimated Cost _______________
ABC CORPORATION
100 Main Street (g) Total Fixed Fee_____________________
Anywhere, USA zip code
Attn: Name, Title, & Phone Number of
Official to Whom Payment is Sent
================================================================================
(h) This invoice/financing request represents reimbursable costs for the period
from _____ to____
================================================================================
<TABLE>
<S> <C> <C> <C> <C> <C>
Cost at Contract
Expenditure Category* Cumulative Percentage of Incurred Cost Completion Amount Variance
A Effort/Hrs. F G H
------------------------------ ----------------------------------
Negotiated Actual (i) Current (j) Cumulative
B C D E
-----------------------------------------------------------------------------------------------------------------------------------
(k) Direct Costs:
-----------------------------------------------------------------------------------------------------------------------------------
(1) Direct Labor
-----------------------------------------------------------------------------------------------------------------------------------
(2) Fringe Benefits
-----------------------------------------------------------------------------------------------------------------------------------
(3) Accountable Property (attach HHS-565)
-----------------------------------------------------------------------------------------------------------------------------------
(4) Materials & Supplies
-----------------------------------------------------------------------------------------------------------------------------------
(5) Premium Pay
-----------------------------------------------------------------------------------------------------------------------------------
(6) Consultant Fees
-----------------------------------------------------------------------------------------------------------------------------------
(7) Travel
-----------------------------------------------------------------------------------------------------------------------------------
(8) Subcontracts
-----------------------------------------------------------------------------------------------------------------------------------
(9) Other
-----------------------------------------------------------------------------------------------------------------------------------
Total Direct Costs
-----------------------------------------------------------------------------------------------------------------------------------
(l) Cost of Money
-----------------------------------------------------------------------------------------------------------------------------------
(m) Overhead
-----------------------------------------------------------------------------------------------------------------------------------
(n) G&A
-----------------------------------------------------------------------------------------------------------------------------------
(o) Fixed Fee
-----------------------------------------------------------------------------------------------------------------------------------
(p) Total Amount Claimed
-----------------------------------------------------------------------------------------------------------------------------------
(q) Adjustments
-----------------------------------------------------------------------------------------------------------------------------------
(r) Grand Totals
-----------------------------------------------------------------------------------------------------------------------------------
</TABLE>
I certify that all payments are for appropriate purposes and in accordance with
the contract.
--------------------------- --------------------
(Name of Official) (Title)
* Attach details as specified in the contract
================================================================================
NIH(RC)-4 ATTACHMENT 2
Rev. 5/97 Page 5
<PAGE>
Contract No. N01-AI-25494
INCLUSION ENROLLMENT REPORT
This report format should NOT be used for data collection from study
participants
--------------------------------------------------------------------------------
Study Title:
--------------------------------------------------------------------------------
Total Enrollment: Protocol Number:
--------------------------------------------------------------------------------
Contract Number:
================================================================================
PART A. TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date
(Cumulative) by Ethnicity and Race
--------------------------------------------------------------------------------
Sex/Gender
---------------------------------------------
Ethnic Category Females Males Unknown or Not Total
Reported
--------------------------------------------------------------------------------
Hispanic or Latino
--------------------------------------------------------------------------------
Not Hispanic or Latino
--------------------------------------------------------------------------------
Unknown (Individuals not reporting
ethnicity)
================================================================================
Ethnic Category: Total of All Subjects*
--------------------------------------------------------------------------------
Racial Categories
--------------------------------------------------------------------------------
American Indian/Alaska Native
--------------------------------------------------------------------------------
Asian
--------------------------------------------------------------------------------
Native Hawaiian or Other Pacific Islander
--------------------------------------------------------------------------------
Black or African American
--------------------------------------------------------------------------------
White
--------------------------------------------------------------------------------
More than one race
--------------------------------------------------------------------------------
Unknown or not reported
================================================================================
Racial Categories: Total of All Subjects*
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
PART B. HISPANIC ENROLLMENT REPORT: Number of Hispanics or Latinos Enrolled
to Date (Cumulative)
--------------------------------------------------------------------------------
Unknown or Not
Racial Categories Females Males Reported Total
--------------------------------------------------------------------------------
American Indian or Alaska Native
--------------------------------------------------------------------------------
Asian
--------------------------------------------------------------------------------
Native Hawaiian or Other Pacific Islander
--------------------------------------------------------------------------------
Black or African American
--------------------------------------------------------------------------------
White
--------------------------------------------------------------------------------
More Than One Race
--------------------------------------------------------------------------------
Unknown or not reported
================================================================================
Racial Categories: Total of Hispanics
or Latinos**
================================================================================
* These totals must agree
** These totals must agree
--------------------------------------------------------------------------------
Inclusion Enrollment Report ATTACHMENT 3
5/2001 (Modified OAMP: October, 2001)
<PAGE>
Contract No. N01-AI-25494
PRIVACY ACT SYSTEM OF RECORDS
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 curricula 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 and Craniofacial 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 Human Genome Research Institute" 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, 285l, 285m, 285n, 285o, 285p, 285q, 287,
287b, 287c, 289a, 289c, and 44 U.S.C. 3101.)
Inclusion Enrollment Report ATTACHMENT 3
5/2001 (Modified OAMP: October, 2001)
<PAGE>
Contract No. N01-AI-25494
PURPOSE(S):
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:
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 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
properly 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.
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.
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.
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).
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.
Medical information may be disclosed in identifiable form to tumor
registries for maintenance of health statistics, e.g., for use in
epidemiologic studies.
(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.
Privacy Act System of Records ATTACHMENT 4
09-25-0200
<PAGE>
Contract No. N01-AI-25494
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).
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.
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.
The Secretary may disclose information to organizations deemed
qualified to carry out quality assessment, medical audits or
utilization reviews.
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:
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. 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.
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.
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.
Implementation Guidelines: These practices are in compliance with
the standards of Chapter 45-13 of the HHS General Administration
Manual, "Safeguarding Records Contained in Systems of Records,"
supplementary Chapter PHS hf: 45-13, and the HHS Automated
Information Systems Security Program Handbook.
Privacy Act System of Records ATTACHMENT 4
09-25-0200
<PAGE>
Contract No. N01-AI-25494
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 1B "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.
Refer to the NIH Manual Chapter for specific conditions on disposal or retention
instructions.
SYSTEM MANAGER(S) AND ADDRESS(ES):
See Appendix I for a listing of current system managers. This system is for use
by all NIH Institutes and Centers. The following system notices have been
subsumed under this umbrella system notice.
09-25-0001, Clinical Research: Patient Records, HHS/NIH/NHLBI
09-25-0010, Research Resources: Registry of Individuals Potentially Exposed to
Microbial Agents, HHS/NIH/NCI
09-25-0015, Clinical Research: Collaborative Clinical Epilepsy Research,
HHS/NIH/NINDS
09-25-0016, Clinical Research: Collaborative Perinatal Project, HHS/NIH/NINDS
09-25-0026, Clinical Research: Nervous System Studies, HHS/NIH/NINDS
09-25-0028, Clinical Research: Patient Medical Histories, HHS/NIH/NINDS and
HHS/NIH/NIDCD
09-25-0031, Clinical Research: Serological and Virus Data in Studies Related to
the Central Nervous System, HHS/NIH/NINDS
09-25-0037, Clinical Research: The Baltimore Longitudinal Study of Aging,
HHS/NIH/NIA
09-25-0038, Clinical Research: Patient Data, HHS/NIH/NIDDK
09-25-0039, Clinical Research: Diabetes Mellitus Research Study of Southwestern
American Indians, HHS/NIH/NIDDK
09-25-0040, Clinical Research: Southwestern American Indian Patient Data,
HHS/NIH/NIDDK
09-25-0042, Clinical Research: National Institute of Dental and Craniofacial
Research Patient Records, HHS/NIH/NIDCR
09-25-0044, Clinical Research: Sensory Testing Research Program, HHS/NIH/NIDCR
09-25-0046, Clinical Research: Catalog of Clinical Specimens from Patients,
Volunteers and Laboratory Personnel, HHS/NIH/NIAID
09-25-0053, Clinical Research: Vision Studies, HHS/NIH/NEI
09-25-0057, Clinical Research: Burkitt'sLymphonma Registry, HHS/NIH/NCI
09-25-0060, Clinical Research: Division of Clinical Sciences Clinical
Investigations, HHS/NIH/NCI
09-25-0067, Clinical Research: National Cancer Incidence Surveys, HHS/NIH/NCI
09-25-0069, NIH Clinical Center Admissions of the National Cancer Institute,
HHS/NIH/NCI
09-25-0074, Clinical Research: Division of Cancer Biology and Diagnosis Patient
Trials, HHS/NIH/NCI
09-25-0077, Biological Carcinogenesis Branch Human Specimen Program, HHS/NIH/NCI
09-25-0126, Clinical Research: National Heart, Lung, and Blood Institute
Epidemiological and Biometric Studies, HHS/NIH/NHLBI
09-25-0128, Clinical Research: Neural Prosthesis and Biomedical Engineering
Studies, HHS/NIH/NINDS
09-25-0129, Clinical Research: Clinical Research Studies Dealing with Hearing,
Speech, Language and Chemosensory Disorders, HHS/NIH/NIDCD
09-25-0130, Clinical Research: Epidemiologic Studies in the Division of Cancer
Epidemiology and Genetics
09-25-0134, Clinical Research: Epidemiology Studies, National Institute of
Environmental Health Sciences, HHS/NIH/NIEHS
Privacy Act System of Records ATTACHMENT 4
09-25-0200
<PAGE>
Contract No. N01-AI-25494
09-25-0142, Clinical Research: Records of Subjects in Intramural Research,
Epidemiology, Demography and Biometry Studies on Aging, HHS/NIH/NIA
09-25-0143, Biomedical Research: Records of Subjects in Clinical, Epidemiologic
and Biometric Studies of the National Institute of Allergy and Infectious
Diseases, HHS/NIH/NIAID
09-25-0145, Clinical Trials and Epidemiological Studies Dealing with Visual
Disease and Disorders in the National Eye Institute, HHS/NIH/NEI
09-25-0148, Contracted and Contract-Related Research: Records of Subjects in
Clinical, Epidemiological and Biomedical Studies of the National Institute of
Neurological Disorders and Stroke and the National Institute on Deafness and
Other Communication Disorders, HHS/NIH/NINDS and HHS/NIH/NIDCD
09-25-0152, Biomedical Research: Records of Subjects in National Institute of
Dental and Craniofacial Research Contracted Epidemiological and Biometric
Studies, HHS/NIH/NIDCR
09-25-0153, Biomedical Research: Records of Subjects in Biomedical and
Behavioral Studies of Child Health and Human Development, HHS/NIH/NICHD
09-25-0154, Biomedical Research: Records of Subjects: 1) Cancer Studies of the
Division of Cancer Prevention and Control, HHS/NIH/NCI; and 2) Women's Health
Initiative (WHI) Studies, HHS/NIH/OD
09-25-0170, Diabetes Control and Complications Trial (DCCT) Data System,
HHS/NIH/NIDDK
09-25-0172, Clinical Research: National Human Genome Research Institute,
HHS/NIH/NHGRI
09-25-0201, Clinical Research: National Institute of Mental Health Patient
Records, HHS/NIH/NIMH
09-25-0205, Alcohol, Drug Abuse, and Mental Health Epidemiologic and Biometric
Research Data, HHS/NIH/NIAAA, HHS/NIH/NIDA and HHS/NIH/NIMH
09-25-0212, Clinical Research: Neuroscience Research Center Patient Medical
Records, HHS/NIH/NIMH
NOTIFICATION PROCEDURE:
To determine if a record exists, write to the appropriate IC Privacy Act
Coordinator listed below. In cases where the requester knows specifically which
System manager to contact, he or she may contact the System manager directly
(See Appendix I). Notification requests should include: individual's name;
current address; date of birth; date, place and nature of participation in
specific research study; name of individual or organization administering the
research study (if known); name or description of the research study (if known);
address at the time of participation; and in specific cases, a notarized
statement (some highly sensitive systems require two witnesses attesting to the
individual's identity). A requester must verify his or her identity by providing
either a notarization of the request or by submitting a written certification
that the is who he or she claims to be and understands that the knowing and
willful request for acquisition of a record pertaining to an individual under
false pretenses is a criminal offense under the Act, subject to a five thousand
dollar fine.
Individuals will be granted direct access to their medical records unless the
System manager determines that such access is likely to have an adverse effect
(i.e., could cause harm) on the individual. In such cases when the System
manager has determined that the nature of the record information requires
medical interpretation, the subject of the record shall be requested to
designate, in writing, a responsible representative who will be willing to
review the record and inform the subject individual of its contents at the
representative's discretion. The representative may be a physician, other health
professional, or other responsible individual. In this case, the medical/dental
record will be sent to the designated representative. Individuals will be
informed in writing if the record is sent to the representative. This same
procedure will apply in cases where a parent or guardian requests notification
of, or access to, a child's or incompetent person's medical record. The parent
or guardian must also verify (provide adequate documentation) their relationship
to the child or incompetent person as well as his or her own identity to prove
their relationship.
If the requester does not know which Institute or Center Privacy Act Coordinator
to contact for notification purposes, he or she may contact directly the NIH
Privacy Act Officer at the following address: NIH Privacy Act Officer, Office of
Management Assessment, 6011 Executive Blvd., Room 601L, Rockville, MD 20852.
NIH Privacy Act Coordinators
Office of the Director, (OD), NIH, Associate Director for Disease Prevention,
OD, NIH, Building 1, Room 260, 1 Center Drive, Bethesda, MD 20892
National Cancer Institute (NCI), Privacy Act Coordinator, NCI, NIH, Building 31,
Room 10A34, 31 Center Drive, Bethesda, MD 20892
Privacy Act System of Records ATTACHMENT 4
09-25-0200
<PAGE>
Contract No. N01-AI-25494
National Eye Institute (NEI), Privacy Act Coordinator, NEI, NIH, Building 31,
Room 6A32, 31 Center Drive, MSC 2510, Bethesda, MD 20892-2510
National Heart, Lung and Blood Institute (NHLBI), Privacy Act Coordinator,
NHLBI, NIH, Building 31, Room 5A08, 31 Center Drive, Bethesda, MD 20892
National Institute on Aging (NIA), Privacy Act Coordinator, NIA, NIH, Building
31, Room 2C12, 31 Center Drive, Bethesda, MD 20892
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Privacy Act
Coordinator, NIAAA, NIH, Wilco Building, Suite, 6000 Executive Blvd., MSC 7003,
Bethesda, MD 20892-7003
National Institute of Allergy and Infectious Diseases (NIAID), Privacy Act
Coordinator, NIAID, NIH, Solar Building, Room 3C-23, 6003 Executive Blvd.,
Bethesda, MD 20892
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS),
Privacy Act Coordinator, NIAMS, NIH, Natcher Building, Room 5AS49, 45 Center
Drive, Bethesda, MD 20892
National Institute of Child Health and Human Development (NICHD), Privacy Act
Coordinator, NICHD, NIH, 6100 Executive Blvd., Room 5D01, North Bethesda, MD
20892
National Institute on Deafness and Other Communication Disorders (NIDCD),
Privacy Act Coordinator, NIDCD, NIH, Building 31, Room 3C02, 9000 Rockville
Pike, Bethesda, MD 20892
National Institute of Dental and Craniofacial Research (NIDCR), Privacy Act
Coordinator, NIDCR, NIH, Natcher Building, Room 4AS-43A, 45 Center Drive MSC
6401, Bethesda, MD 20892-6401
National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), Privacy
Act Coordinator, NIDDK, NIH, Building 31, Room 9A47, 31 Center Drive, Bethesda,
MD 20892
National Institute on Drug Abuse (NIDA), Privacy Act Coordinator, NIDA, NIH,
Parklawn Building, Room 10A-42, 5600 Fishers Lane, Rockville, MD 20857
National Institute of Environmental Health Sciences (NIEHS), Privacy Act
Coordinator, NIEHS, NIH, P.O. Box 12233, Research Triangle Park, NC 27709
National Institute of Mental Health (NIMH), Privacy Act Coordinator, NIMH, NIH,
Parklawn Building, Room 7C-22, 5600 Fishers Lane, Rockville, MD 20857
National Institute of Neurological Disorders and Stroke (NINDS), Privacy Act
Coordinator, NINDS, NIH, Federal Building, Room 816, 7550 Wisconsin Avenue,
Bethesda, MD 20892
National Human Genome Research Institute (NHGRI), Office of Policy Coordination,
Bldg. 31, Room 4B09, Bethesda, MD 20892
RECORD ACCESS PROCEDURE:
Same as Notification Procedures. Requesters should reasonably specify the record
contents being sought. An individual may also request an accounting of
disclosures of his/her record, if any.
CONTESTING RECORD PROCEDURE:
Contact the appropriate official at the address specified under Notification
Procedure, and reasonably identify the record, specify the information being
contested, and state corrective action sought, with supporting information to
show how the record is inaccurate, incomplete, untimely, or irrelevant.
RECORD SOURCE CATEGORIES:
The system contains information obtained directly from the subject individual by
interview (face-to-face or telephone), written questionnaire, or by other tests,
recording devices or observations, consistent with legislation and regulation
regarding informed consent and protection of human subjects. Information is also
obtained from other sources, including but not limited to: referring medical
physicians, mental health/alcohol/drug abuse or other health care providers;
hospitals; organizations providing biological specimens; relatives; guardians;
schools; and clinical medical research records.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
Privacy Act System of Records ATTACHMENT 4
09-25-0200
<PAGE>
Contract No. N01-AI-25494
Appendix I: System Manager(s) and Address(es)
Office of the Director, NIH, Associate Director for Disease Prevention, OD, NIH,
Building 1, Room 260, 1 Center Drive, Bethesda, MD 20892
National Cancer Institute, Computer Systems Analyst, DCBD, NCI, NIH, Executive
Plaza North, Room 344, Bethesda, MD 20892
American Burkitt's Lymphoma Registry, Division of Cancer Etiology, NCI, NIH,
Executive Plaza North, Suite 434, 6130 Executive Blvd., Bethesda, MD 20892
Chief, Genetic Epidemiology Branch, , DCEG, NCI, NIH, Executive Plaza South,
Room 7122, MSC 7236, 6120 Executive Blvd., Bethesda, MD 20892-7236
Program Director, Research Resources, Biological Carcinogenesis Branch, DCE,
NCI, NIH, Executive Plaza North, Room 540, 6130 Executive Blvd., Bethesda, MD
20892
Chief, Environmental Epidemiology Branch, DCE, NCI, NIH, Executive Plaza North,
Room 443, 6130 Executive Blvd., Bethesda, MD 20892
Associate Director, Surveillance Program, DCPC, NCI, NIH, Executive Plaza North,
Room 343K, 6130 Executive Blvd., Bethesda, MD 20892
Head, Biostatistics and Data Management Section, DCS, NCI, NIH, 6116 Executive
Blvd., Room 702, Bethesda, MD 20892
Chief, Clinical Research Branch, Biological Response Modifiers Program,
Frederick Cancer Research and Development Center, DCT, NCI, NIH, 501 W. 7th
Street, Suite #3, Frederick, MD 21701
Deputy Branch Chief, Navy Hospital, NCI--Naval Medical Oncology Branch, DCT,
NCI, NIH, Building 8, Room 5101, Bethesda, MD 20814
Chief, Pharmaceutical Management Branch, Cancer Therapy Evaluation Program, DCT,
NCI, NIH, Executive Plaza North, Suite 804, Bethesda, MD 20892
Director, Extramural Clinical Studies, BRB, BRMP, DCT, NCI, NIH, Frederick
Cancer Research and Development Center, Fort Detrick, Frederick, MD 21701
National Eye Institute, Clinical Director, NEI, NIH, Building 10, Room 10N-202,
10 Center Drive, Bethesda, MD 20892
Director, Division of Biometry and Epidemiology, NEI, NIH, Building 31, Room
6A-52, 31 Center Drive, Bethesda, MD 20892
National Heart Lung and Blood Institute, Administrative Officer, Division of
Intramural Research, NHLBI, NIH, Building 10 Room 7N220, 10 Center Drive, MSC
1670, Bethesda, MD 20892-1670
Senior Scientific Advisor, OD, Division of Epidemiology and Clinical
Applications, NHLBI, NIH, Federal Building, 220, 7550 Wisconsin Avenue,
Bethesda, MD 20892
National Institute on Aging, Computer Scientist, Longitudinal Studies Branch,
IRP, NIH, Gerontology Research Center, GRC, 4940 Eastern Avenue, Baltimore, MD
21224
Associate Director, Epidemiology, Demography and Biometry Program, NIA, NIH,
Gateway Building, Suite 3C309, 7201 Wisconsin Avenue, Bethesda, MD 20892
National Institute on Alcohol Abuse and Alcoholism, Deputy Director, Division of
Biometry and Epidemiology, NIAAA, NIH, Willco Building, Suite 514, 6000
Executive Blvd., MSC 7003, Bethesda, MD 20892-7003
Deputy Director, Div. of Clinical and Prevention Res., NIAAA, NIH, Willco
Building, Suite 505, 6000 Executive Blvd., MSC 7003, Bethesda, MD 20892-7003
National Institute of Allergy and Infectious Diseases, Chief, Respiratory
Viruses Section, LID, NIAID, NIH, Building 7, Room 106, 9000 Rockville Pike,
Bethesda, MD 20892
Chief, Hepatitis Virus Section, LID, NIAID, NIH, Building 7, Room 202, 9000
Rockville Pike, Bethesda, MD 20892
Chief, Epidemology and Biometry Branch, DMID, NIAID, NIH, Solar Building, Room
3A24, Bethesda, MD 20892
Privacy Act System of Records ATTACHMENT 4
09-25-0200
<PAGE>
Contract No. N01-AI-25494
Special Assistant, Clinical Research Program, DAIDS, NIAID, NIH, Solar Building,
Room 2C-20, 6003 Executive Blvd., Bethesda, MD 20892
National Institute of Arthritis and Musculoskeletal and Skin Diseases, Clinical
Director, NIAMS, NIH, Building 10, Room 9S205, 10 Center Drive, Bethesda, MD
20892
National Institute of Child Health and Human Development, Chief, Contracts
Management Branch, NICHD, NIH, Executive Plaza North, Room 7A07, 6100 Executive
Blvd., North Bethesda, MD 20892
National Institute on Deafness and Other Communication Disorders, Acting
Director of Intramural Research, NIDCD, NIH, Building 31, Room 3C02, 31 Center
Drive, Bethesda, MD 20892
Director, Division of Human Communication, NIDCD, NIH, Executive Plaza South,
Room 400C, 6120 Executive Boulevard - MSC 7180, Bethesda, MD 20892-7180
National Institute of Dental and Craniofacial Research, Deputy Clinical
Director, NIDCR, NIH, Building 10, Room 1N-113, 10 Center Drive, MSC 1190,
Bethesda, MD 20892-1190
Research Psychologist, Gene Therapy and Therapeutics Branch, NIDCR, NIH,
Building 10, Room 1N114, 10 Center Drive, MSC 1190, Bethesda, MD 20892-1190
National Institute of Diabetes and Digestive and Kidney Diseases, Chief,
Clinical Investigations, NIDDK, NIH, Building 10, Room 9N222, 10 Center Drive,
Bethesda, MD 20892
Chief, Phoenix Clinical Research Section, NIDDK, NIH, Phoenix Area Indian
Hospital, Room 541, 4212 North 16th Street, Phoenix, AZ 85016
Chief, Diabetes Research Section, DPB, DDEMD, NIDDK, NIH, Natcher Building, Room
5AN-18G, 45 Center Drive, MSC 6600, Bethesda, MD 20892
National Institute on Drug Abuse, Privacy Act Coordinator, NIDA, NIH, Parklawn
Building, Room 10A-42, 5600 Fishers Lane, Rockville, MD 20857
National Institute of Environmental Health Sciences, Chief, Epidemiology Branch,
NIEHS, NIH, P.O. Box 12233, Research Triangle Park, NC 27709
National Institute of Mental Health, Director, Intramural Research Program,
NIMH, NIH, Building 10, Room 4N-224, 9000 Rockville Pike, Bethesda, MD 20892
Privacy Act Coordinator, NIMH, NIH, 6001 Executive Blvd., Room 6112, Bethesda,
MD 20982
National Institute of Neurological Disorders and Stroke, Privacy Act
Coordinator, NINDS, NIH, Neuroscience Center, 6001 Executive Blvd., Suite 3305,
MSC 9531, Bethesda, MD 20892-9531
Chief, Epilepsy Branch, NINDS, NIH, Neuroscience Center, 6001 Executive Blvd.,
Suite 2110, MSC 9523, Bethesda, MD 20892-9523
Assistant Director, CNP, DIR, NINDS, NIH, Building 10, Room 5N226, 10 Center
Drive, Bethesda, MD 20892
Deputy Chief, Laboratory of Central Nervous Systems Studies, Intramural Research
Program, NINDS, NIH, Building 36, Room 5B21, 9000 Rockville Pike, Bethesda, MD
20892
Director, Division of Fundamental Neuroscience and Developmental Disorders,
NINDS, NIH, Neuroscience Center, 6001 Executive Blvd., Suite 2136, MSC 9527,
Bethesda, MD 20892-9527
Director, Division of Convulsive, Infectious and Immune Disorders, NINDS, NIH,
Neuroscience Center, 6001 Executive Blvd., Suite 2110, MSC 9521, Bethesda, MD
20892-9521
Director, Division of Stroke, Trauma, and Neurodegenerative Disorders, NINDS,
NIH, Neuroscience Center, 6001 Executive Blvd., Suite 2209, MSC 9525, Bethesda,
MD 20892-9525
Division of Experimental Therapeutics and Clinical Trials, NINDS, NIH,
Neuroscience Center, 6001 Executive Blvd., Suite 2213, MSC 9520, Bethesda, MD
20892-9520
National Human Genome Research Institute (NHGRI), Clinical Director, NHGRI,
Bldg. 10, Room 10C101D, 10 Center Drive, Bethesda, MD 20892
Privacy Act System of Records ATTACHMENT 4
09-25-0200
<PAGE>
Contract No. N01-AI-25494
PROCUREMENT OF CERTAIN EQUIPMENT
Notwithstanding any other clause in this contract, the Contractor will not be
reimbursed for the purchase, lease, or rental of any item of equipment listed in
the following Federal Supply Groups, regardless of the dollar value, without the
prior written approval of the Contracting Officer.
67 - Photographic Equipment
69 - Training Aids and Devices
70 - General Purpose ADP Equipment, Software, Supplies and Support
(Excluding 7045-ADP Supplies and Support Equipment.)
71 - Furniture
72 - Household and Commercial Furnishings and Appliances
74 - Office Machines and Visible Record Equipment
77 - Musical Instruments, Phonographs, and Home-type Radios
78 - Recreational and Athletic Equipment
When equipment in these Federal Supply Groups is requested by the Contractor and
determined essential by the Contracting Officer, the Government will endeavor to
fulfill the requirement with equipment available from its excess personal
property sources, provided the request is made under a contract. Extensions or
renewals of approved existing leases or rentals for equipment in these Federal
Supply Groups are excluded from the provisions of this article.
RESEARCH PATIENT CARE COSTS
(a) Research patient care costs are the costs of routine and ancillary
services provided to patients participating in research programs described
in this contract.
(b) Patient care costs shall be computed in a manner consistent with the
principles and procedures used by the Medicare Program for determining the
part of Medicare reimbursement based on reasonable costs. The Diagnostic
Related Group (DRG) prospective reimbursement method used to determine the
remaining portion of Medicare reimbursement shall not be used to determine
patient care costs. Patient care rates or amounts shall be established by
the Secretary of HHS or his duly authorized representative.
(c) Prior to submitting an invoice for patient care costs under this contract,
the contractor must make every reasonable effort to obtain third party
payment, where third party payors (including Government agencies) are
authorized or are under a legal obligation to pay all or a portion of the
charges incurred under this contract for patient care.
(d) The contractor must maintain adequate procedures to identify those
research patients participating in this contract who are eligible for
third party reimbursement.
(e) Only those charges not recoverable from third party payors or patients and
which are consistent with the terms and conditions of the contract are
chargeable to this contract.
NIH (RC)-7 (4/1/84) ATTACHMENT 5
OMB Bulletin 81-16
<PAGE>
Contract No. N01-AI-25494
NIH(RC)-11 ATTACHMENT 6
4/1/84
NIH (RC)-7 (4/1/84) ATTACHMENT 5
OMB Bulletin 81-16
<PAGE>
Contract No. N01-AI-25494
GOVERNMENT PROPERTY - SCHEDULE I-A
Item Description Unit Cost # Units Total Cost
--------------------------------------------------------------------------------
1. Ricoh 2050L Fax Machine $ 907 (incl. tax) 10 $9,070
2. Server Upgrade $4,738 1 $4,738
3. Freezer $7,765 (incl. freight) 1 $7,765
Attachment 7
9/30/02
NIH (RC)-7 (4/1/84) ATTACHMENT 5
OMB Bulletin 81-16
<PAGE>
Contract No. N01-AI-25494
--------------------------------------------------------------------------------
REPORT OF GOVERNMENT OWNED, CONTRACTOR HELD PROPERTY
--------------------------------------------------------------------------------
CONTRACTOR: CONTRACT NUMBER
--------------------------------------------------------------------------------
ADDRESS REPORT DATE:
-----------------------------------------
FISCAL YEAR:
-----------------------------------------
-----------------------------------------
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CLASSIFICATION BEGINNING OF ADJUSTMENTS END OF PERIOD
PERIOD
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#ITEMS VALUE GFP CAP DELETIONS #ITEMS VALUE
ADDED ADDED
--------------------------------------------------------------------------------
LAND>=$25K
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LAND<$25K
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OTHER REAL>=$25K
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OTHER REAL<$25K
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PROPERTY UNDER CONST>=$25K
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PROPERTY UNDER CONST<$25K
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PLANT EQUIP>=$25K
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PLANT EQUIP<$25K
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SPECIAL TOOLING >= $25K
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SPECIAL TOOLING<$25K
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SPECIAL TEST EQUIP>=$25K
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SPECIAL TEST EQUIP<$25K
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AGENCY PECULIAR>=$25K
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AGENCY PECULIAR<$25K
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MATERIAL>=$25K (CUMULATIVE)
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PROPERTY UNDER MFR>=$25K
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PROPERTY UNDER MFR<$25K
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SIGNED BY: DATE SIGNED:
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NIH (RC)-7 (4/1/84) ATTACHMENT 5
OMB Bulletin 81-16