Document:

Officers' Certificate

 Exhibit 4.2 
  

OFFICERS’ CERTIFICATE ESTABLISHING 
 THE TERMS OF THE ADDITIONAL NOTES 
 Pursuant to Section 301 of the Indenture 
  
 Pursuant to (i) resolutions adopted by the Board of Trustees of
Washington Real Estate Investment Trust (the “Trust”) dated as of September 30, 2005 and (ii) Section 301 of the Indenture, dated as of August 1, 1996, between the Trust and J.P. Morgan Trust Company, National
Association (successor to The First National Bank of Chicago), as Trustee (the “Indenture”), the Trust shall reopen the series of notes titled “5.35% Senior Notes due May 1, 2015” originally issued by the Trust on
April 26, 2005 in the aggregate principal amount of $50,000,000 (the “Existing Notes”) and issue $100,000,000 principal amount of additional notes as a part of the same series of Securities as the Existing Notes (the “Additional
Notes”) in accordance with the terms herein. Accordingly, we, Edmund B. Cronin, Jr., a trustee and the Chairman, President and Chief Executive Officer of the Trust, and Sara L. Grootwassink, Chief Financial Officer of the Trust, do hereby
deliver this Certificate establishing the following terms of the Additional Notes and do hereby certify that (terms used in this Certificate and not defined herein having the same definitions as in the Indenture): 
  
 (1) The Additional Notes shall be part of the same series of
Securities as the Existing Notes. The Additional Notes shall collectively, with the Existing Notes, constitute a single series of debt securities under the Indenture. All terms of the Additional Notes are intended to be the same as, and pari passu
with, the terms of the Existing Notes. 
  
 (2)
The aggregate principal amount of the Existing Notes and the Additional Notes that may be authenticated and delivered under the Indenture (except for Notes authenticated and delivered upon registration of transfer of, or in exchange for, or in lieu
of, other Notes pursuant to Sections 304, 305, 306, 906, 1107 or 1305 of the Indenture) shall be $150,000,000. 
  
 (3) The Additional Notes shall mature on May 1, 2015, subject to prior redemption at the option of the Trust as described in
paragraph (9). 
  
 (4) The rate at which the
Additional Notes shall bear interest shall be 5.35% per annum. The date from which such interest shall accrue shall be April 26, 2005; the Interest Payment Dates on which such interest will be payable shall be May 1 and
November 1 in each year, beginning November 1, 2005, and on the Maturity Date; the Regular Record Dates for the interest payable on the Additional Notes on any Interest Payment Date shall be 15 calendar days prior to the related Interest
Payment Date regardless of whether such day is a Business Day; the interest on the Additional Notes shall be computed on the basis of a 360-day year consisting of twelve 30-day months. 
  
 (5) The Additional Notes shall be issuable in denominations of $1,000 and integral multiples thereof.

 (6) The place where the principal of (and Make-Whole Amount, if any) and interest on the
Additional Notes shall be payable and the Additional Notes may be surrendered for registration of transfer or exchange and where notices or demands to or upon the Trust in respect of the Additional Notes and the Indenture may be served shall be the
Corporate Trust Office of J.P. Morgan Trust Company, National Association, at 4 New York Plaza, 1st Floor, New York, New York 10004. 
  
 (7) The entire outstanding principal amount of the Additional Notes (and Make-Whole Amount, if any) shall be payable upon declaration of
acceleration of the maturity thereof pursuant to Section 502 of the Indenture. 
  
 (8) Payment of the principal of (and Make-Whole Amount, any) and interest on the Additional Notes shall be payable in Dollars and the
Additional Notes shall be denominated in Dollars. 
  
 (9) The Additional Notes, as well as the Existing Notes, shall be redeemable at any time at the option of the Trust, in whole or in part, at a Redemption Price, payable in Dollars, equal to the sum of (i) the principal amount of the
Additional Notes being redeemed plus accrued interest thereon to the redemption date and (ii) the Make-Whole Amount, if any, with respect to such Additional Notes. 
  
 “Make-Whole Amount” shall mean, in connection with any optional redemption or accelerated
payment of any of the Additional Notes, the excess, if any, of (a) the aggregate present value as of the date of such redemption or accelerated payment of each dollar of principal being redeemed or paid and the amount of interest (exclusive of
interest accrued to the date of redemption or accelerated payment) that would have been payable in respect of each such dollar if such redemption or accelerated payment had not been made, determined by discounting, on a semi-annual basis, such
principal and interest at the Reinvestment Rate (determined on the third Business Day preceding the date such notice of redemption is given or declaration of acceleration is made) from the respective dates on which such principal and interest would
have been payable if such redemption or accelerated payment had not been made, over (b) the aggregate principal amount of the Additional Notes being redeemed or paid. 
  
 “Reinvestment Rate” shall mean with respect to the Additional Notes, 0.20%, plus, in each
case, the arithmetic mean of the yields under the heading “Week Ending” published in the most recent Statistical Release under the caption “Treasury Constant Maturities” for the maturity (rounded to the nearest month)
corresponding to the remaining life to maturity, as of the payment date of the principal of the Additional Notes being redeemed or paid. If no maturity exactly corresponds to such maturity, yields for the two published maturities most closely
corresponding to such maturity shall be calculated pursuant to the immediately preceding sentence and the Reinvestment Rate shall be interpolated or extrapolated from such yields on a straight-line basis, rounding in each of such relevant periods to
the nearest month. For the purposes of calculating the Reinvestment Rate, the most recent Statistical Release published prior to the date of determination of the Make-Whole Amount shall be used. 
  

 -2- 

 “Statistical Release” shall mean the statistical release designated
“H.15(519)” or any successor publication which is published weekly by the Federal Reserve System and which establishes yields on actively traded United States government securities adjusted to constant maturities, or, if such statistical
release is not published at the time of any determination under the Indenture, then such other reasonably comparable index which shall be designated by the Trust. 
  
 (10) The Trust shall not be obligated to redeem, repay or purchase the Additional Notes pursuant to any
sinking fund or analogous provision or at the option of a Holder thereof. 
  
 (11) The Holders of the Additional Notes shall have no special rights in addition to those provided in the Indenture upon the occurrence of any particular events. 
  
 (12) Other than as set forth herein, there shall be no
deletions from, modifications of or additions to the Events of Default or additional covenants of the Trust with respect to the Additional Notes set forth in the Indenture. 
  
 (13) The Additional Notes will be represented by a single global security (the “Global
Security”) registered in the name of the Depository Trust Company (“DTC”) or its nominee. DTC or its nominee will credit, on its book-entry registration and transfer system, the respective amounts of Additional Notes
represented by the Global Security. Ownership of beneficial interests in the Global Security will be limited to institutions that have accounts with DTC or its nominee (“Participants”) and to persons that may hold interests through
Participants. Beneficial owners of interests in the Global Security may exchange such interests for Additional Notes of like tenor of any authorized form and denomination only in the manner provided in Section 305 of the Indenture. DTC shall be
the depositary of the Global Security. The form of such Global Security, attached hereto as Exhibit A, is hereby approved. 
  
 (14) The Additional Notes shall not be issuable as Bearer Securities. 
  
 (15) Interest on any of the Additional Notes shall be payable only to the Person in whose name that the
Additional Note (or one or more Predecessor Securities thereof) is registered at the close of business on the Regular Record Date for such interest. 
  
 (16) Sections 1402 and 1403 of the Indenture shall be applicable to the Additional Notes. 
  
 (17) The Additional Notes shall not be issuable in
definitive form except under the circumstances described in Section 305 of the Indenture. 
  
 (18) The Trust shall not pay Additional Amounts as contemplated by Section 1010 of the Indenture on the Additional Notes. 

 

 -3- 

 (19) The Trust shall have no obligation to permit the conversion of the Additional Notes
into Common Shares or Preferred Shares of the Trust. 
  

			
	 	 	  

	 	 	Edmund B. Cronin, Jr.,
	 	 	Chairman, President and Chief Executive Officer
	 	 	  
  

	Date: October 3, 2005	 	Sara L. Grootwassink,
	 	 	Chief Financial Officer

  

 -4-Award/Contract

 Exhibit 10.1 
  
 *** Confidential treatment has been requested as to certain portions of this contract. Such omitted confidential information has been
designated by an asterisk and has been filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, and the Commission’s rules and regulations promulgated under the
Freedom of Information Act, pursuant to a request for confidential treatment.*** 
  

			
	ADB Number: N02-CP-65500	 	OMB NO. 0990-0115

							
	AWARD/CONTRACT	  	 1.      THIS CONTRACT IS A RATED ORDER UNDER DPAS (15 CPR 350)
	  	RATING        	  	PAGE     OF     PAGES 1                            31

			
	 2.      CONTRACT (Proc. last Indent.) NO.
 HHSN261200655000C
	  	 3.      EFFECTIVE DATE
          10/01/2005
	  	4.      REQUISITION PURCHASE
         REQUEST/PROJECT NO.
	  	  

											
						
	 5.      ISSUED BY
	 	CODE	  	 	  	 6.      ADMINISTERED BY (If other than item 5)
	  	 CODE
	  	 
	 National Cancer Institute
 Research Contracts Branch, ESS
	  	 	  	     OD
     Office of Director
     Division of Epidemiology and Genetics
     (RFP No. N02CP51011-66)
	  	 	  	 
	Executive Plaza South, Suite 600, Room 6001	  	 	  	  	 	  	 
	 6120 Executive Blvd MSC 7196
	  	 	  	  	 	  	 
	 Bethesda Maryland 20892-7196
	  	 	  	  	 	  	 

							
	 7.      NAME AND ADDRESS OF THE CONTRACTOR (No., street, city, county, State and ZIP
Code)
	  	 8.      DELIVERY
 þ FOB Destination      ̈ FOB Origin

		
	 SeraCare BioServices
 217 Perry Pkwy
 Gaithersburg, Maryland 20877-2164
	  	 9.      DISCOUNT FOR PROMPT PAYMENT

			
	PLACE OF PERFORMANCE: Frederick, Maryland United States	  	 10.    SUBMIT INVOICES
 (4 copies unless otherwise specified)
 TO THE ADDRESS SHOWN IN
	  	 ITEM

	 CODE
	 	 FACILITY CODE
	  	ð	  	 SEE SECTION G
 ARTICLE
G.4.

											
						
	 11.    SHIP TO/MARK FOR
SEE SECTION F, ARTICLE F.1.
	 	CODE	  	 	 	 12.    PAYMENT WILL BE MADE BY
SEE SECTION G, ARTICLE G.4.
	  	 CODE
	  	 

							
	 13.    AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION
	 	 14.    ACCOUNTING AND APPROPRIATION DATA

	 ̈ 10 U.S.C. 2304(c) (    )	 	 ̈ 41 U.S.C. 253(c) (    )	 	CAN1    68333405	 	TIN    330056054
	 	 	CAN2    ________	 	DOC No.       ________
	 	 	 	 	OC CODE      25.2E	 	LOC    ________

												
						
	 15A. ITEM NO.
	  	15B. SUPPLIES/SERVICES	  	15C. QUANTITY	  	15D. UNIT	  	15E. UNIT PRICE	  	 	15F. AMOUNT
	 TITLE:
	  	Laboratory Support for Processing and Storage of Biomedical Specimens for Persons at High Risk for Cancer	  	 CAN1:
 CAN2:
	  	$
$	 660,000
                
	 CURRENT OBLIGATION:
	  	 	  	 	  	 	  	 	  	$	 660,000
	 CONTRACT PERIOD:
	  	10/01/2005 through 09/30/2010	  	 	  	 	  	 	  	$	                
	 CONTRACT TYPE:
	  	Cost Plus Fixed Fee, COMPLETION, Work Assignment	  	 	  	 	  	$	                
	 	  	 	  	15G. TOTAL AMOUNT OF CONTRACT	  	$	14,102,584

															
	
	16. TABLE OF CONTENTS
	 (X)

	  	SEC.

	  	 DESCRIPTION

	  	PAGE(S)

	  	(X)

	  	SEC.

	  	 DESCRIPTION

	  	PAGE(S)

	PART I - THE SCHEDULE	  	PART II - CONTRACT CLAUSES
	X	  	A	  	SOLICITATION/CONTRACT FORM	  	1	  	X	  	I	  	CONTRACT CLAUSES	  	23
	X	  	B	  	SUPPLIES OF SERVICES AND PRICES/COSTS	  	4	  	PART III - LIST OF DOCMENTS, EXHIBITS
AND OTHER ATTACH
	X	  	C	  	DESCRIPTION/SPECS/WORK STATEMENT	  	6	  	X	  	J	  	LIST OF ATTACHMENTS	  	30
	X	  	D	  	PACKAGING AND MARKING	  	12	  	PART IV - REPRESENTATIONS AND
INSTRUCTIONS
	X	  	E	  	INSPECTION AND ACCEPTANCE	  	13	  	X	  	K	  	REPRESENTATIONS, CERTIFICATIONS AND	  	31
	X	  	F	  	DELIVERIES OR PERFORMANCE	  	13	  	  	  	OTHER STATEMENTS OF OFFERORS	  	 
	X	  	G	  	CONTRACT ADMINISTRATION DATA	  	14	  	 ̈	  	L	  	INSTRS., CONDS., AND NOTICES TO OFFERORS	  	 
	X	  	H	  	SPECIAL CONTRACT REQUIREMENTS	  	20	  	 ̈	  	M	  	EVALUATION FACTORS FOR AWARD	  	 

							
	
	CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
		
	17.  ̈ CONTRACTORS NEGOTIATED AGREEMENT (Contractor is required to sign this
docment and return 1 copies to issuing office.) Contractor agrees to furnish and deliver all items or perform all the services set forth or otherwise identified above and on any continuation sheets for the consideration stated herein. The rights and
obligations of the parties to this contract shall be subject to and governed by the following documents (a) this award/contract, (b) the solicitation, if any, and (c) such provisions, representations, certifications, and specifications, as are
attached or incorporated by reference herein. (Attachments are listed herein.)	  	 18.  ̈ AWARD (Contractor is not
required to sign this docment.)
 Your offer on Solicitation Number _______________ including the addition or changes made by you which additions or changes
are set forth in full above, is herein accepted as to the items listed above and on any continuation sheets. This award consummates the contract which consists of the following documents (a) the Government’s solicitation and your offer and (b)
this award/contract. No further contractual document is necessary.

		
	 19A. NAME AND TITLE OF SIGNER (Type or print)
 Michael F. Crowley, II / CEO
	  	 20A. NAME OF CONTRACTING OFFICER
 SHARON A.
MILLER

				
	19B. NAME OF CONTRACTOR	 	19C. DATE SIGNED	  	20B. UNITED STATES OF AMERICA	 	20C. DATE SIGNED

											
						
	 BY
	 	 /s/ Michael F. Crowley, II
	 	9-29-05	 	 BY
	 	 /s/ Sharon A. Miller
	 	 9-30-05

	 	 	(Signature of person authorized to sign)	 	 	 	 	 	(Signature of Contracting officer)	 	 

 Contract No. HHSN261200655000C 
  
 DETAILED TABLE OF CONTRACT CONTENTS 
  

					
	 PART I - THE SCHEDULE
	  	 
		
	 SECTION A - SOLICITATION/CONTRACT FORM
	  	 
		
	 SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
	  	4
	 ARTICLE B.1.
	  	BRIEF DESCRIPTION OF SUPPLIES OR SERVICES	  	4
	 ARTICLE B.2.
	  	ESTIMATED COST AND FIXED FEE	  	4
	 ARTICLE B.3.
	  	PROVISIONS APPLICABLE TO DIRECT COSTS	  	4
	 ARTICLE B.4.
	  	ADVANCE UNDERSTANDINGS	  	6
	 SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
	  	6
	 ARTICLE C.2.
	  	REPORTING REQUIREMENTS	  	12
	 SECTION D - PACKAGING, MARKING AND SHIPPING
	  	14
	 ARTICLE D.1.
	  	PACKAGING	  	14
	 ARTICLE D.2.
	  	MARKING	  	14
	 ARTICLE D.3.
	  	SHIPPING	  	15
	 SECTION E - INSPECTION AND ACCEPTANCE
	  	15
	 SECTION F - DELIVERIES OR PERFORMANCE
	  	15
	 ARTICLE F.1.
	  	DELIVERIES	  	15
	 ARTICLE F.2.
	  	CLAUSES INCORPORATED BY REFERENCE	  	16
	 SECTION G - CONTRACT ADMINISTRATION DATA
	  	17
	 ARTICLE G.1.
	  	PROJECT OFFICER	  	17
	 ARTICLE G.2.
	  	KEY PERSONNEL	  	18
	 ARTICLE G.3.
	  	WORK ASSIGNMENT PROCEDURES	  	18
	 ARTICLE G.4.
	  	INVOICE SUBMISSION/CONTRACT FINANCING REQUEST	  	20
	 ARTICLE G.5.
	  	CONTRACT FINANCIAL REPORT	  	21
	 ARTICLE G.6.
	  	INDIRECT COST RATES	  	21
	 ARTICLE G.7.
	  	GOVERNMENT PROPERTY	  	22
	 ARTICLE G.8.
	  	POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE	  	23
	 SECTION H - SPECIAL CONTRACT REQUIREMENTS
	  	24
	 ARTICLE H.1.
	  	HUMAN SUBJECTS	  	24
	 ARTICLE H.2.
	  	HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)	  	24
	 ARTICLE H.3.
	  	NEEDLE EXCHANGE	  	24
	 ARTICLE H.4.
	  	PRIVACY ACT	  	25
	 ARTICLE H.5.
	  	EPA ENERGY STAR REQUIREMENTS	  	25
	 ARTICLE H.6.
	  	CONFIDENTIALITY OF INFORMATION	  	25
	 ARTICLE H.7.
	  	PUBLICATION AND PUBLICITY	  	26
	 ARTICLE H.8.
	  	PRESS RELEASES	  	26
	 ARTICLE H.9.
	  	REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE	  	26
	 ARTICLE H.10.
	  	ANTI -LOBBYING	  	26
		
	 PART II - CONTRACT CLAUSES
	  	27
	 SECTION I - CONTRACT CLAUSES
	  	27
	 ARTICLE I.1.
	  	GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT	  	27
	 ARTICLE I.2.
	  	AUTHORIZED SUBSTITUTION OF CLAUSES	  	30
	 ARTICLE I.3.
	  	ADDITIONAL CONTRACT CLAUSES	  	30
	 ARTICLE I.4.
	  	ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT	  	31
		
	 PART III
	  	35
	 SECTION J - LIST OF ATTACHMENTS
	  	35
	 1.
	  	Sample Contract Work Assignment	  	35
	 2.
	  	Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts	  	35
	 3.
	  	Financial Report of Individual Project/Contract	  	35
	 4.
	  	Instructions for Completing form NIH 2706, Financial Report of Individual Project/Contract	  	35

  

 2 

 Contract No. HHSN261200655000C 
  

					
	 5.
	  	Privacy Act System of Records	  	35
	 6.
	  	Safety and Health	  	35
	 7.
	  	Procurement of Certain Equipment	  	35
	 8.
	  	Government Property - Schedule I-B, 1page	  	35
	 9.
	  	Government Property - Schedule II-A, 7 pages	  	35
	 10.
	  	Report of Government Owned, Contractor Held Property	  	35
		
	 PART IV
	  	36
	 SECTION K - REPRESENTATIONS AND CERTIFICATIONS
	  	36
	 1.
	  	Annual Representations and Certifications	  	36

  

 3 

 Contract No. HHSN261200655000C 
  
 SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS 
  
 ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES 
  
 The objective of this acquisition are to support molecular epidemiology projects undertaken by the Division of Cancer Epidemiology and
Genetics, National Cancer Institute. These technical services shall include: 
  

	 	•	 	Accessioning and processing biological specimens for molecular epidemiology studies 

  

	 	•	 	Organizing, aliquoting and dispersing samples to DCEG collaborators 

  

	 	•	 	Maintaining the existing biorepository and expanding it as necessary 

  

	 	•	 	Maintaining accurate information on the quality, quantity and location of samples, and to provide these data in a timely manner for the computerized sample inventory

  

	 	•	 	Exploring new or improved methods to achieve the above objectives in a more cost-efficient manner 

  

	 	•	 	Conducting method studies as required to resolve issues of direct relevance to specimen processing or storage 

  

	 	•	 	Evaluating and piloting new technologies germane to the contract mission 

  

	 	•	 	Maintaining appropriate quality assurance systems for the biorepository and bioprocessing laboratories. 

  
 ARTICLE B.2. ESTIMATED COST AND FIXED FEE 
  

	a.	The estimated cost of this contract is $*****. 

  

	b.	The fixed fee for this contract is $*****. The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer, and
subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract. Payment of fixed fee shall not be made in less than monthly increments.

  

	c.	The Government’s obligation, represented by the sum of the estimated cost plus fixed fee, is $14,102,584. 

  

	d.	Total funds currently available for payment and allotted to this contract are $660,000, of which $***** represents the estimated costs, and of which $***** represents the fixed fee.
For further provisions on funding, see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE I.2. Authorized Substitutions of Clauses. 

  

	e.	It is estimated that the amount currently allotted will cover performance of the contract through December 31, 2005. 

  

	f.	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; 

  

 4 

 Contract No. HHSN261200655000C 
  

	 	(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 b. (2) below; 

  

	 	(6)	Consultant costs; 

  

	 	(7)	Subcontracts; 

  

	 	(8)	Patient care costs; 

  

	 	(9)	Accountable Government property (defined as both real and personal property with an acquisition cost of $1,000 or more and a life expectancy of more than two years) and
“sensitive items” (defined and listed in the Contractor’s Guide for Control of Government Property), 1990, regardless of acquisition value. 

  

	b.	Travel Costs 

  

	 	(1)	Domestic Travel 

  

	 	(a)	Total expenditures for domestic travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall not exceed $15,006
without the prior written approval of the Contracting Officer. 

  

	 	(b)	The Contractor shall invoice and be reimbursed for all travel costs in accordance with their travel policies; however travel costs shall not exceed those authorized by Federal
Acquisition Regulations (FAR) 31.205-46. 

  

	 	(2)	Foreign Travel 

  

	 	(a)	Total expenditures for foreign travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall not exceed $11,853
without the prior written approval of the Contracting Officer. 

  

	 	(b)	 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 

  

 5 

 Contract No. HHSN261200655000C 
  

	 	 
absence from the project of more than one person if such are suggested; and (f) what additional functions may be performed by the travelers to
accomplish other purposes of the contract and thus further benefit the project. 

  
 ARTICLE B.4. ADVANCE UNDERSTANDINGS 
  
 Other provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting Officer. 
  

	a.	Contract Number Designation 

  
 On all correspondence submitted under this contract, the contractor agrees to clearly identify the two contract numbers that appear on the face page of
the contract as follows: 
  
 Contract No. HHSN261200655000C

 ADB Contract No. N02-CP-65500 
  
 SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT 
  
 ARTICLE C.1. STATEMENT OF WORK 
  
 Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel,
material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work below: 
  

	 	1)	The Contractor shall provide the services described below in accordance with Contractor-developed, Government-approved protocols: 

  

	 	a)	Separation and viable cryopreservation of blood mononuclear lymphocytes; 

  

	 	b)	Separation, aliquoting and storage of serum, plasma and/or urine as needed; 

  

			
	NOTE:	  	A “typical” serum sample would be 8 ml (range 0.5 - 40 ml); urine or other body fluids would average 50 ml (5 - 200 ml)

  

	 	c)	Cryopreservation of bone marrow samples; 

  

	 	d)	Cryopreservation of whole tumor tissue; 

  

			
	NOTE:	  	Specimens may range in size from 0.5 - 100 or more grams. Tumor tissues will be cut to specified sizes and flash frozen in liquid nitrogen. They will then be stored in vials in liquid
nitrogen. Tumor lines, which have already been established, may be viably cryopreserved and stored.

  

 6 

 Contract No. HHSN261200655000C 
  

	 	e)	Viable cryopreservation of previously established lymphoblastoid cell lines; 

  

	 	f)	Storage of DNA and other biological materials as specified by the Project Officer (e.g., pathology slides and tissue block); 

  

	 	g)	Extraction of DNA from biologic materials; 

  

	 	h)	Specimen processing as required by NCI to preserve special biologic materials; 

  

	 	i)	Logging in, labeling and tracking of each vial of each sample employing an NCI developed computerized specimen tracking system, including all laboratory safeguards to insure the
fidelity and purity of each sample; and 

  

			
	NOTE:	  	In one “typical” day, the most labor-intensive procedure would be the processing of whole blood for cryopreservation of leukocytes. As many as 10 samples of approximately 30 ml
each could be received.

  

	 	j)	Maintenance of the previously-established repository currently containing more than 2.9 million biological specimens and allowance for an estimated increase of up to 50% of
freezer storage space. 

  

	 	k)	Under the direction of the Project Officer conduct laboratory methods studies that establish optimal conditions for collection, processing, shipping and storage of biologic
materials. 

  
 Processing services shall be
available routinely between the hours of 9:00 a.m. and 2:00 p.m., Monday through Friday, and at any other time (including nights, weekends and holidays) by special arrangement, usually with advance notice. A laboratory staff member shall be
available during nonbusiness hours for emergency specimen processing (as might occur when a patient dies). A biohazard area adequate for processing specimens with Acquired Immunodeficiency Syndrome (AIDS) shall be available for the processing of all
biologic samples. 
  

	 	2)	 The Contractor shall supply a messenger service to pick up specimens or inter-laboratory communication from medical care facilities in the Washington, D.C., area or
at area transportation centers (i.e., Dulles International, D.C. National and Baltimore/Washington International Airports). This messenger service shall be supplied by the Contractor and not subcontracted to commercial carriers. All specimens
submitted to the laboratory for processing shall be scheduled in advance, except in emergencies as detailed below. Specimens shall be delivered to 

  

 7 

 Contract No. HHSN261200655000C 
  

	 	 
the Contractor’s laboratory within four hours of notification for pick-up. Specimens shall be protected from temperature extremes by use of insulated
containers or other acceptable means as needed. A portable liquid nitrogen container for transport of frozen cells or tumor specimens shall also be required. Only specimens provided by or approved by the Project Officer shall be accepted for
processing and storage by the Contractor. 

  

	 	3)	The Contractor shall be responsible for recording and monitoring the location of all specimens that are being sent or received through use of an electronic log of all requests and
specimens. The Contractor shall be responsible for monitoring, shipping and receipt of specimens to minimize delay or loss. If a specimen is not received within four hours of expected delivery, the Contractor shall inform the Project Officer by
electronic mail. An after-hours telephone number of the Contractor’s on-call staff member shall be available to assist in this follow-up and the staff member shall be available at that number. The Contractor shall be responsible for immediately
tracing the location of delinquent specimens not received when expected. All specimens that are of questionable research value shall be noted and the Project Officer notified by telephone within 24 hours, as well as in writing within 3 business
days, providing identifying names or numbers, quantity, place of origin, a concise narrative description of the event, etc., so that appropriate action can be initiated. The Contractor shall designate a specific individual to be responsible for
after-hours specimen processing and name one or more alternates to act when the primary person is not available. 

  

	 	4)	The Contractor shall maintain a repository of biologic specimens for the NCI Division of Cancer Epidemiology and Genetics (DCEG). This repository shall include frozen serum, plasma,
urine, tumor tissue, tumor tissue extracts, whole red blood cells, separated and frozen white blood cells, or fractions of white blood cell populations, bone marrow cells, body fluids, lymphoblastoid cell lines, DNA, stool specimens or smears or
slides, pathology paraffin blocks, and other types of specimens as specified by the Project Officer. These materials shall be maintained at optimum temperatures for long-term storage, including liquid nitrogen, if appropriate.

  

	 	5)	All specimens will be submitted to the Contractor, accompanied by written identification of the specimen source. Specimens from members of NCI-associated families will be submitted
with a unique identification number to insure compatibility with NCI laboratory computer databases. Specimens shall be assigned a unique code number, which shall be the only identification of the specimen in future laboratory processing, dispersal,
etc. This code number shall comply with the format and convention established by the NCI Project Officer and DCEG investigators. The name of the donor shall not be used in labeling of specimens or in correspondence concerning the specimen by
laboratory personnel. Such labeling shall uniquely identify each vial of each specimen and the quality of that individual vial will be recorded and updated as needed in the NCI-developed computer system. 

  

 8 

 Contract No. HHSN261200655000C 
  

	 	6)	The Contractor shall provide and train primary and backup staff in the operation of a computerized record system for specimens which has been developed and furnished by the Project
Officer. Using this system, the laboratory shall keep records of all manipulation on all specimens and accurately enter data on each specimen. The data shall include but not be limited to vial identification number, study ID, material type and
material description, volume, weight or cell concentration, freezer location, subject ID, crisis events, date received, specimen vial quality, etc. Data shall be entered into the system, with attention to accuracy, within 48 hours of receipt, or as
specified by the NCI Project Officer. The Contractor shall be responsible for extracting this information from either data forms or electronic media, which will be transmitted with the samples. The Contractor shall also use this system to monitor
and track all activities related to specimens. 

  

	 	7)	The Contractor shall prepare a variety of specimens for storage. Specifically, white blood cell separation, fractionation and viable cryopreservation; red blood cell
cryopreservation; serum separation and storage of aliquots; plasma separation and storage of aliquots; tissue freezing; urine, serum, or blood fluid lyophilization; freezing of stool specimens; and other techniques as required. Specimens shall be
stored in containers impervious to entry of CO2 so that they can be shipped on dry ice. Shipment of specimens in
liquid nitrogen “dry shippers” may also be required. In order to ensure the viability of valuable specimens, the Contractor shall be prepared to have appropriate personnel travel to a contract site, foreign or domestic, to train local
staff on optimal techniques for freezing viable material. 

  

	 	8)	Freezers shall be connected to a temperature recording system indicating consistency of temperature, which shall be monitored on a scheduled basis. Freezer malfunctions must give
warning by means of an alarm system. The Contractor must provide a central alarm system monitored 24-hours a day, 365 days a year. A switch-operated electric generator of appropriate wattage for emergency operation of the contract’s freezers
and other critical equipment shall be connected and be maintained on standby in the event of a major power outage. Liquid nitrogen freezers must have automatic filling mechanisms drawing on a constant central source of liquid nitrogen with emergency
back up. All unplanned defrostings must be logged, giving date and times during which defrostings were in effect and temperature reached, and reported to the Project Officer by telephone and in writing, as described above. 

 

	 	9)	 The laboratory/biorepository shall keep clear records of all manipulations on all specimens and carefully document specimen type, volume, cell concentration,
source, “crisis events”, etc. for each sample. The exact freezer location shall be known for each specimen and shall be maintained in the computerized inventory system. Inventory records shall include number of vials, exact location of
vials and specimen 

  

 9 

 Contract No. HHSN261200655000C 
  

	 	 
type. The Contractor shall conduct a representative inventory of a portion of the stored specimens on an annual basis. Thorough quality control protocols
must be designed, documented and approved by the NCI Project Officer. These protocols must be rigorously implemented in the conduct of the inventories. The results of each inventory shall be documented in the Annual Technical Progress Report.

  

	 	10)	The Contractor shall respond only to written (electronic mail will be acceptable) requests for biological specimens from collaborating investigators, which have been approved
by the NCI Project Officer or his/her designee(s). Specimens shall not be sent to any investigator without a written request from the NCI Project Officer or his/her designee(s). 

  
 The Contractor shall not supply an outside collaborator with any information
concerning the biological specimens other than code number, specimen type or other information essential to specimen processing. Requests for identification of the patient, the diagnosis, demographic data or other such information shall be referred
to the NCI Project Officer. 
  
 The Contractor shall
NEVER send out the last vial from a particular specimen without explicit authorization from the Project Officer. 
  

	 	11)	The Contractor shall prepare specimens for shipment, supply shipping containers appropriate to maintain specimens in the proper state (cool, frozen, deep frozen, etc.) and make
arrangements through commercial air freight companies and other carriers to send biologic specimens to collaborating investigators in an expeditious (e.g., overnight or same day) fashion. The local in-house delivery service shall be used for these
particular specimens to ensure expeditious delivery under optimum conditions. In some cases, commercial freight companies shall be used in overnight shipments to investigators in other cities. The Contractor shall be responsible for notifying the
receiving laboratory of the specimens’ shipment and anticipated arrival time to insure that the receiving laboratory is prepared to receive the specimens. Peripheral blood cells shall be aliquotted for storage in suitable quantities for
subsequent testing. Other specimens, such as red blood cells, plasma, serum, urine, stool, tumor tissue, and body fluids shall be processed for storage in appropriate aliquots. 

  

	 	12)	The laboratory shall retain written, hard copy records of inventory sheets and shall supply copies in suitable form for computer entry by NCI computer support personnel. Laboratory
personnel shall verify the accuracy of information as it is entered in the computer against the original data, and errors shall be corrected. 

  

 10 

 Contract No. HHSN261200655000C 
  

	 	13)	The Contractor shall be prepared to process the following quantities of materials: 

  

					
	 Material type or task

	  	Max Daily
(vials)

	  	Typical total
monthly
volume

	 1) Fresh blood, mouthwash (buccal cells), urine for immediate processing
	  	30	  	700
	 2) Process whole blood to lymphocyotes and cryopreserve (included in #1)
	  	10	  	250
	 3) EBV transformation of lymphocytes or whole blood (included in #1)
	  	na	  	10
	 4) Withdrawing vials from inventory
	  	700	  	15,000
	 5) Adding vials to inventory
	  	1,000	  	22,000
	 6) Thawing/aliquoting miscellaneous specimens including DNA
	  	na	  	2,000
	 7) DNA purification
	  	na	  	2,000

  
 Although these are
ESTIMATES of the amount of work, the Contractor must be able to accommodate highly variable amounts of processing and possible changes in specimen types and volumes depending on the new studies evolving during the contract (e.g. increased
processing of buccal swabs and rinses; gastric juice; feces; urine, etc.). All prioritization of the specimen processing is determined by the NCI Project Officer. Not all maximal quantities of each material will arrive on a given day. 
  

	 	14)	The Contractor shall handle international shipments of biological specimens (blood components, urine, gastric juice, and biopsy specimens) and clearance of these shipments through
U.S. and foreign customs. The Contractor must work with a shipping/customs agent to coordinate shipping, clear specimens through customs at the U.S. entry port, transfer to appropriate courier/express delivery service for shipment within the
U.S., and notify the Contractor of all arrangements so that specimens can be easily tracked. Close coordination is vital because these samples may need to be kept frozen with dry ice, and freezer-to-freezer shipping time must be less than 72 hours.
Large quantities of samples are shipped from Europe, the East Indies, Africa, China and other geographic locales. In each instance, the repository Contractor shall have responsibility for coordinating logistics to insure their timely arrival,
including contracting with appropriate customs brokers and agents to expedite shipment and customs clearances. 

  

	 	15)	 The Contractor, under the direction of the Project Officer, shall develop methods and procedures that improve the quality and efficiency of current biologic
specimen collection, 

  

 11 

 Contract No. HHSN261200655000C 
  

	 	 
processing, shipping or storage protocols. Examples of such studies are: Specimen stability with respect to various storage conditions and analyses; nucleic
acid extraction methodology; comparison of serum and plasma in serologic assays; evaluation of specimen shipping protocols; evaluation of processing/aliquoting for chip-based approaches; evaluation of suitable methods to preserve RNA, especially
mRNA. 

  
 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.1. DELIVERIES of this contract: 
  

	 	1)	Quarterly Computerized and Written Reports 

  
 The Contractor shall submit quarterly computerized reports via electronic mail summarizing the status of all newly received specimens and outlining all
dispersals by the laboratory. A summary of all correspondence consisting of requests for shipment, cover letters and inquiries from outside collaborators shall be maintained and made available upon request. Emphasis shall be on conciseness as well
as comprehensiveness. 
  
 The first quarterly report shall cover
the period consisting of the first full calendar quarter following the effective date of the contract and shall be due on or before January 15, 2006. Thereafter, quarterly reports shall be due on/before the 15th day of the month following each
quarterly reporting period. A quarterly report shall not be required when submitting the annual reports or final report. 
  

	 	2)	Annual Technical Progress Reports 

  
 The Contractor shall prepare Annual Technical Progress Reports which explain the progress of work performed under this contract. Each report shall
describe the progress of the project to date, noting all technical areas in which effort is being directed and indicating the status of work in each area. This report shall include: 
  

	 	a)	A quantitative summary of the number of specimens processed by the Contractor, their type and investigator source; 

  

	 	b)	Shipments and logistics; 

  

 12 

 Contract No. HHSN261200655000C 
  

	 	c)	An indication of current problems that may impede performance under the contract and proposed corrective action; and 

  

	 	d)	A discussion of work to be performed during the next reporting period. 

  
 The annual report shall include an up-to-date inventory of the Repository and its contents. Additional interim reports may be requested as necessary.

  
 The first annual report shall cover the period consisting of
the first full calendar year following the effective date of the contract and shall be due on or before November 1, 2006. Emphasis shall be on conciseness as well as comprehensiveness. A separate annual technical progress report shall not be
required when submitting the final report. 
  

	 	3)	Final Technical Progress Report 

  
 The Contractor shall submit a final technical progress report on or before the expiration date of the contract. The final report shall include information
in sufficient detail to describe comprehensively the results achieved and shall include a summation of the work performed for the entire contract period of performance. 
  

	b.	Other Reports/Deliverables 

  

	 	1)	Monthly Cost Accounting System (CAS) Transactions Data File 

  
 The Division of Cancer Epidemiology and Genetics (DCEG) implemented a Cost Accounting System (CAS) to accommodate the requirement for study level cost
reporting for individual NCI investigators. The contractor shall contribute to CAS by submitting monthly personnel expenditures and other direct charges itemized by study and investigator. This information shall be submitted by the contractor
directly to DCEG’s IT (information technology) support contractor, who will input the data into the CAS. The monthly submission should contain an entry representing the combined costs associated with each unique investigator/study combination
that received support during the month. The contractor’s monthly submission will be concatenated into a centralized reporting database with all other transactions from the Division’s support services contractors. 
  
 A website has been created that allows contractors to search for the unique
identification codes for each DCEG investigator and existing study. This website can be found at: http://www.dceg.cancer.gov/codes/index.html. For studies that do not have an established study code, the NCI investigator can request one from the DCEG
Intramural System. The format for reporting, and 

  

 13 

 Contract No. HHSN261200655000C 
  
 
the name and number of the contact person for the DCEG IT contractor will be provided by the NCI Project Officer. 
  
 The monthly CAS data shall be submitted to the DCEG IT contractor no later
than the 18th of each month for the previous month’s expenditures. This requirement does not take the place of
any other financial reporting required elsewhere in this contract. 
  

	 	(3)	Addresses for Submission of Technical Progress Reports 

  
 Technical progress reports, identified in paragraphs a.1) through a.3), above, shall be addressed to: 
  

			
	 ORIGINAL:
	  	 Contracting Officer

	 	  	 Epidemiology and Support Section

	 	  	 Research Contracts Branch, OD

	 	  	 National Cancer Institute

	 	  	 Executive Plaza South, Room 6109

	 	  	 6120 EXECUTIVE BLVD MSC 7196

	 	  	 BETHESDA MD 20892-7196

		
	 2 COPIES:
	  	Project Officer
	 	  	 Office of the Director

	 	  	 Division of Cancer Epidemiology & Genetics

	 	  	 Executive Plaza South, Room 7030

	 	  	 6120 EXECUTIVE BLVD MSC 7242

	 	  	 BETHESDA MD 20892-7242

  
 SECTION D - PACKAGING, MARKING AND
SHIPPING 
  
 ARTICLE D.1. PACKAGING 
  
 The Contractor shall properly package all biological and environmental materials for
shipment to subcontractor laboratories and other destinations. Packaging shall ensure the integrity of the material during the shipment period, and shall take into account maintenance of the optimal temperature for the specimens, as well as all
applicable legal restrictions related to real or perceived hazards due to flammability, infectivity, or other characteristics of the specimens. 
  
 ARTICLE D.2. MARKING 
  
 In addition to ensuring proper labeling of individual specimens and freezer boxes, the Contractor shall prepare all shipping packages of biological and environmental materials with appropriate labels and marking,
including the nature of the material and its destination. Also indicated on packages should be the name and telephone number of the Contractor’s representative in the event the shipping company needs to contact the Contractor. 
  

 14 

 Contract No. HHSN261200655000C 
  
 ARTICLE D.3. SHIPPING 
  
 Biological and environmental materials transferred within the local metropolitan area shall be delivered by the Contractor’s messenger service. For destinations
outside of the local area, shipments shall be made by overnight express mail. Special arrangements shall be made for international shipments. In cooperation with the NCI Principal Investigator for each project, the Contractor shall obtain
appropriate Material Transfer Agreements for all materials sent to subcontractors and collaborators, as part of the Contractor’s responsibility for oversight of proper use of NCI specimens handled by the Contractor. 
  
 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 identified in ARTICLE G.1 is the authorized representative of the Contracting Officer. 

  

	c.	Inspection and acceptance will be performed at the National Cancer Institute, 6120 Executive Boulevard, Room 7020, Bethesda, MD 20892 

  
 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 52.246-5,
Inspection Of Services — Cost Reimbursement (April 1984). 
  
 SECTION
F - DELIVERIES OR PERFORMANCE 
  
 ARTICLE F.1. 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 

  

 15 

 Contract No. HHSN261200655000C 
  

	 	 
below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of the contract: 

  

							
	Item

	  	 Description

	  	Quantity

	  	 Delivery Schedule

	(1)	  	Quarterly Computerized and Written Reports	  	3	  	First report due 01/15/06; all others due on the 15th day of
the month following each Quarterly reporting period.
				
	(2)	  	Annual Technical Progress Report	  	3	  	 November 1, 2006
 November 1, 2007
 November 1, 2008
 November 1, 2009

				
	(3)	  	Final Technical Progress Report	  	3	  	On or before October 1, 2010
				
	(4)	  	Monthly CAS Transactions Data File	  	1 per month	  	On or before the 18th day of Each month of the
contract.

  

	b.	The above items (1) through (3) shall be addressed and delivered to the undersigned. Item (4) shall be provided in accordance with Article C.2.

  

			
	 Original:
	  	 Contracting Officer

	 	  	 Epidemiology and Support Section

	 	  	 Research Contract Branch, OD

	 	  	 National Cancer Institute

	 	  	 Executive Plaza South, Room 620

	 	  	 6120 EXECUTIVE BLVD MSC 7196

	 	  	 BETHESDA, MD 20892-7196

		
	 Copies:
	  	 Project Officer

	 	  	 Office of the Director

	 	  	 Division of Cancer Epidemiology & Genetics

	 	  	 Executive Plaza South, Room 7020

	 	  	 6120 EXECUTIVE BLVD MSC 7242

	 	  	 BETHESDA, MD 20892-7242

  
 ARTICLE F. 2. CLAUSES INCORPORATED
BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998) 
  
 This contract incorporates the
following clause(s) 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. 

  

 16 

 Contract No. HHSN261200655000C 
  
 
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 and Assistant Project Officers will represent the Government
for the purpose of this contract: 
  
 Dr. Jim Vaught,
Project Officer 
  
 Assistant Project Officers: 
  
 Neil Caporaso 
 Mark Greene 
 Alan Hildesheim 
 Charles Rabkin 
  
 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 Assistant Project Officers will be responsible for coordinating the requirements of their individual DCEG Branch. Assistant Project Officer’s will not be allowed to initiate Work Assignments for contract
support or to modify ongoing contract tasks without discussing with the Project Officer. 
  
 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. 
  

 17 

 Contract No. HHSN261200655000C 
  
 ARTICLE G.2. KEY PERSONNEL 
  
 Pursuant to the Key Personnel clause incorporated in Section I of this contract, the following individual(s) are considered to be essential to the work being performed
hereunder: 
  

			
	 Name

	  	 Title

	 Katheryn Shea
	  	 Principal Investigator

	 Anekella Bharathi
	  	 Assistant Investigator

	 Carla Chorley
	  	 Senior Manager

  
 ARTICLE G.3. WORK ASSIGNMENT
PROCEDURES 
  
 In providing support under this contract, the Contractor shall
initiate work only when so directed by a Work Assignment (Attachment provided in SECTION J). Approval of a Work Assignment shall not constitute approval to exceed any item listed in the contract or general clauses of the contract. Work
Assignment amounts shall not exceed the total amounts listed in the contract (time, dollars, effort, consultants, travel, etc.). The Project Officer with Contracting Officer approval, is authorized to initiate Work Assignments and to sign Work
Assignments indicating satisfactory performance/delivery of the services/product required in each Work Assignment. The Contractor shall assure, prior to commencing work on any Work Assignment, that written approval of the Project Officer and the
Contracting Officer has been obtained. A Work Assignment which does not contain both Contracting Officer and Project Officer approval signatures shall be considered invalid and costs incurred for such work shall be considered unallowable. The
Contractor shall not exceed the estimated labor hours, estimated Work Assignment amount, or change the Work Assignment leader without prior written approval of the Project Officer and the Contracting Officer by modification of the Work Assignment.
The day-to-day operational and administrative details of the Work Assignment system will be established by the Project Officer with input from the Contractor. The work assignment system will operate within the following general guidelines:

  

	a.	Work Assignment (W.A.) Information 

  

	 	(1)	All work to be assigned under this contract shall relate directly to one or more of the work areas listed in the Statement of Work. 

  

	 	(2)	Each W.A. shall be written for the conduct of a specific, finite task. 

  

	 	(3)	Each new W.A. shall be numbered serially beginning with 01. 

  

	 	(4)	Each W.A. shall be completed on the form entitled “NCI Contract Work Assignment” and listed as an Attachment in Section J of this contract. 

  

	 	(5)	Upon award of the contract, an Administrative Work Assignment as shown in SECTION J, Attachments, shall be issued on a yearly basis. This Work Assignment will cover the time and
expenditures necessary for the administration of the contract. 

  

	b.	Initiation of a W.A. 

  

	 	(1)	The Project Officer will initiate Part I of the W.A. 

  

 18 

 Contract No. HHSN261200655000C 
  

	 	(2)	The Contractor shall complete Part II and obtain the appropriate signature. The Contractor shall forward the proposed W.A. to the Project Officer. 

  

	 	(3)	Upon receipt of the proposed W.A. and after determining that the proposed W.A. is acceptable, the Project Officer will sign Part II to indicate recommendation for approval and
forward to the Contracting Officer. 

  

	 	(4)	Upon receipt, the Contracting Officer will review the proposed W.A. 

  

	 	(a)	If approved, the Contracting Officer will sign Part II to indicate approval and will forward the W.A. to the Contractor with a copy to the Project Officer. 

 

	 	(b)	If not approved, the Contracting Officer will notify the Project Officer, stating the reasons for disapproval. 

  

	 	(5)	After receipt of the approved W.A., the Contractor shall begin work. The period of performance shall never precede the Contracting Officer approval date. 

 

	c.	Modification to a W.A. 

  

	 	(1)	Each amendment to an existing Work Assignment shall contain the original W.A. number and shall designate a modification number. Modification numbers for each W.A. shall be serially
numbered beginning with 01 (for example, Work Assignment 01, Modification No. 01). 

  

	 	(2)	Each W.A. modification shall set forth in specific detail which portion(s) of the W.A. is to be modified. All Cost/Labor modifications shall be in the following format:

  
 Authorized to Date This Modification Revised

  
 Estimate 
  
 Cost Elements 
 (List Each Element) 
  

	d.	Conclusion of a W.A. 

  

	 	(1)	For each W.A. performed, the Contractor shall prepare PART III of the Work Assignment for submission to the Contracting Officer. 

  

	 	(2)	This PART III submission shall include all actual information (cost, effort, and deliverables) relative to the W.A. 

  

	 	(3)	PART III of the W.A. shall be submitted as soon as possible and not to exceed three months after the closing date of the W.A. For those work assignments which expire within three
months prior to the contract expiration date, PART III of the Work Assignment shall be submitted on the final contract day. 

  

 19 

 Contract No. HHSN261200655000C 
  

	 	(4)	After verification that all work is complete and deliverables have been received and accepted, the Project Officer will sign Part III of the W.A. to indicate recommendation for
approval and forward the W.A. to the Contracting Officer. 

  

	 	(5)	After verification that the W.A. has been satisfactorily completed, the Contracting Officer will approve completion of the W.A. by signing Part III of the W.A. and forward to the
Contractor. 

  
 ARTICLE G.4. INVOICE SUBMISSION/CONTRACT
FINANCING REQUEST 
  

	a.	Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts NIH(RC)-1 are attached and made part of this contract. The instructions and the following directions
for the submission of invoices/financing request must be followed to meet the requirements of a “proper” payment request pursuant to FAR 32.9. 

  

	 	(1)	Invoices/financing requests shall be submitted as follows: 

  

	 	(a)	To be considered a “proper” invoice in accordance with FAR 32.9, Prompt Payment, each invoice shall clearly identify the two contract numbers that appear on the face page
of the contract as follows: 

  
 Contract No. (This
is the 17 digit number that appears in Block 2 of the SF-26, i.e. HHSN261200655000C.) 
  
 ADB Contract No. (This is the 10 digit number that appears in the upper left hand corner of the SF-26, i.e. N02-CP-65500.) 
  

	 	(b)	An original and two copies to the following designated billing office: 

  
 Contracting Officer 
 Research Contracts
Branch 
 National Cancer Institute, NIH 
 EPS, Room 6109 
 6120 EXECUTIVE BLVD MSC 7196 
 BETHESDA MD 20892-7196 
  

	 	(2)	Inquiries regarding payment of invoices should be directed to the designated billing office, (301) 496-8611. 

  

	b.	Each invoice shall include a summary of costs incurred on each work assignment. The total costs incurred on all work assignments for the month shall match the total amount billed on
the invoice. 

  

 20 

 Contract No. HHSN261200655000C 
  
 ARTICLE G.5. CONTRACT FINANCIAL REPORT 
  

	a.	Financial reports on the attached Form NIH 2706, Financial Report of Individual Project/Contract, shall be submitted by the Contractor in accordance with the Instructions for
Completing Form NIH 2706, which accompany the form, in an original and two copies, not later than the 30th working day after the close of the reporting period. The line entries for subdivisions of work and elements of cost (expenditure categories)
which shall be reported within the total contract are discussed in paragraph e., below. Subsequent changes and/or additions in the line entries shall be made in writing. 

  

	b.	Unless otherwise stated in that part of the Instructions for Completing Form NIH 2706, entitled “PREPARATION INSTRUCTIONS,” all columns A through J, shall be
completed for each report submitted. 

  

	c.	The first financial report shall cover the period consisting of the FIRST FULL THREE CALENDAR MONTHS following the date of the contract, in addition to any fractional part of the
initial month. Thereafter, reports will be on a quarterly basis. 

  

	d.	The Contracting Officer may require the Contractor to submit detailed support for costs contained in one or more interim financial reports. This clause does not supersede the record
retention requirements in FAR Part 4.7. 

  

	e.	The listing of expenditure categories to be reported is incorporated within the Financial Report of Individual Project/Contract, NIH 2706, SECTION J, ATTACHMENT 3, attached hereto
and made a part of this contract. 

  

	f.	The Government may unilaterally revise the NIH 2706 to reflect the allotment of additional funds. 

  
 ARTICLE G.6. 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. 
  

 21 

 Contract No. HHSN261200655000C 
  
 ARTICLE G.7. 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 
 6011 Building, Suite 637 
 6011 EXECUTIVE BLVD
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-B 

  
 Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this contract, the Contractor is hereby authorized to acquire the property listed in the
attached Schedule I-B for use in direct performance of the contract, on receipt of the Contracting Officer’s written approval, based on contractor-furnished prices and evidence of competition. 
  

	d.	Property Acquired Under Predecessor Contract - Schedule II-A 

  
 Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this contract, the Contractor is hereby authorized to retain custody of all Government
Property acquired or furnished under predecessor Contract No. N02-CP-11001 for use in direct performance of this contract. Accountability for the items is hereby authorized to be transferred to this contract from the predecessor contract. Upon
completion of each contract, the Contractor agrees to furnish to the Contracting 

  

 22 

 Contract No. HHSN261200655000C 
  
 
Officer, without delay, the inventory schedule covering all Government Property furnished or acquired for use in the performance of the predecessor contract
as provided by the clause, GOVERNMENT PROPERTY, of that contract and the instructions contained in DHHS Publication entitled, Contractor’s Guide for Control of Government Property, (1990). 
  
 ARTICLE G.8. 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, interim evaluations will be prepared annually to coincide with the anniversary date of the contract. 
  
 Interim and final evaluations will be provided to the Contractor as soon as
practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. 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: 
  
 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. 
  

 23 

 Contract No. HHSN261200655000C 
  
 SECTION H - SPECIAL CONTRACT REQUIREMENTS 
  

ARTICLE H.1. HUMAN SUBJECTS 
  
 It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or
delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic
use involving humans without the prior written approval of the Contracting Officer. 
  
 ARTICLE H.2. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE) 
  
 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. 
  
 The Contractor shall provide written documentation that all human materials obtained as a result of research involving human subjects
conducted under this contract, by collaborating sites, or by subcontractors identified under this contract, were obtained with prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45
CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the Contractor. 
  
 Provision by the Contractor to the Contracting Officer of a properly completed
“Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly Optional Form 310), certifying IRB review and approval of the protocol from which the human materials
were obtained constitutes the written documentation required. The human subject certification can be met by submission of a self designated form, provided that it contains the information required by the “Protection of Human Subjects Assurance
Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly Optional Form 310) 
  
 ARTICLE H.3. 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. 108-447, Title V-General Provisions
	  	2005	  	10/1/04 - 9/30/05
	 Section 505
	  	 	  	 

  

 24 

 Contract No. HHSN261200655000C 
  
 ARTICLE H.4. 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 5. 
  
 ARTICLE H.5.
EPA ENERGY STAR REQUIREMENTS 
  
 Executive Order 13123, “Greening the
Government Through Efficient Energy Management” and FAR 23.203 require that when Federal Agencies acquire energy using products, they select, where life-cycle cost-effective, and available, ENERGY STAR® or other energy efficient products. 
  
 Unless the Contracting Officer determines otherwise, all energy-using products acquired under
this contract must be either an ENERGY STAR® or
other energy efficient product designated by the Department of Energy’s Federal Energy Management Program (FEMP). 
  
 For more information about ENERGY STAR® see http://www.energystar.gov/ 
  
 For more information about FEMP see http://www.eere.energy.gov/ 
  

ARTICLE H.6. CONFIDENTIALITY OF INFORMATION 
  
 The following information is covered by HHSAR Clause 352.224-70, Confidentiality of Information (MARCH 2005): 
  

	 	•	 	Identification of specimen source or donor name; 

  

	 	•	 	All records of manipulations on all specimens; 

  

	 	•	 	Information concerning the identification of the patient, the diagnosis, demographic information or other such information; 

  

	 	•	 	Written, hard-copy records of inventory sheets. 

  

 25 

 Contract No. HHSN261200655000C 
  
 ARTICLE H.7. 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 Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN261200655000C.” 
  
 ARTICLE H.8. 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. 108-447, Title V-General Provisions
	  	2005	  	10/1/04 - 9/30/05
	 Section 506
	  	 	  	 

  
 ARTICLE H.9. 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.10. ANTI -LOBBYING 
  

	a.	Pursuant to Public Law(s) cited in paragraph c., below, contract funds shall only be used for normal and recognized executive-legislative relationships. Contract funds shall not be
used, for publicity or propaganda purposes; or for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or
any State legislature, except in presentation to the Congress or any State legislature itself. 

  

	b.	Contract funds shall not be used to pay salary or expenses of the contractor or any agent acting for the contractor, related to any activity designed to influence legislation or
appropriations pending before the Congress or any State legislature. 

  

					
	 c.      Public Law and Section No.
	  	Fiscal Year	  	Period Covered
	 for a., above: P.L. 108-447, Title V-General Provisions Section 503a
	  	2005	  	10/1/04 - 9/30/05
	 for b., above: P.L. 108-447, Title V-General Provisions Section 503b
	  	2005	  	10/1/04 - 9/30/05

  

 26 

 Contract No. HHSN261200655000C 
  
 PART II - CONTRACT CLAUSES 
  
 SECTION I - CONTRACT CLAUSES 
  
 ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE 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
	  	Jul 2004	  	Definitions (Over $100,000)
			
	 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 2003	  	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)
			
	 52.204-7
	  	Oct 2003	  	Central Contractor Registration
			
	 52.209-6
	  	Jan 2005	  	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
	  	Oct 2004	  	Pension Adjustments and Asset Reversions

  

 27 

 Contract No. HHSN261200655000C 
  

					
			
	 52.215-18
	  	Jul 2005	  	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
	  	Dec 2002	  	Allowable Cost and Payment
			
	 52.216-8
	  	Mar 1997	  	Fixed Fee
			
	 52.219-8
	  	May 2004	  	Utilization of Small Business Concerns (Over $100,000)
			
	 52.219-9
	  	Jul 2005	  	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
	  	Jun 2003	  	Convict Labor
			
	 52.222-21
	  	Feb 1999	  	Prohibition of Segregated Facilities
			
	 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
	  	Aug 2003	  	Toxic Chemical Release Reporting (Over $100,000)
			
	 52.225-1
	  	Jun 2003	  	Buy American Act - Supplies
			
	 52.225-13
	  	Mar 2005	  	Restrictions on Certain Foreign Purchases
			
	 52.227-1
	  	Jul 1995	  	Authorization and Consent
			
	 52.227-2
	  	Aug 1996	  	Notice and Assistance Regarding Patent and Copyright Infringement (Over $100,000)
			
	 52.227-3
	  	Apr 1984	  	Patent Indemnity
			
	 52.227-14
	  	Jun 1987	  	Rights in Data - General
			
	 52.232-9
	  	Apr 1984	  	Limitation on Withholding of Payments
			
	 52.232-17
	  	Jun 1996	  	Interest (Over $100,000)
			
	 52.232-20
	  	Apr 1984	  	Limitation of Cost

  

 28 

 Contract No. HHSN261200655000C 
  

					
	 52.232-23
	  	Jan 1986	  	Assignment of Claims
			
	 52.232-25
	  	Oct 2003	  	Prompt Payment, Alternate I (Feb 2002)
			
	 52.232-33
	  	Oct 2003	  	Payment by Electronic Funds Transfer—Central Contractor Registration
			
	 52.233-1
	  	Jul 2002	  	Disputes
			
	 52.233-3
	  	Aug 1996	  	Protest After Award, Alternate I (Jun 1985)
			
	 52.233-4
	  	Oct 2004	  	Applicable Law for Breach of Contract Claim
			
	 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 I (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)
			
	 52.244-6
	  	Dec 2004	  	Subcontracts for Commercial Items
			
	 52.245-5
	  	May 2004	  	Government Property (Cost-Reimbursement, Time and Material, or Labor-Hour Contract)
			
	 52.246-25
	  	Feb 1997	  	Limitation of Liability - Services (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

  

 29 

 Contract No. HHSN261200655000C 
  

					
	 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 SERVICE CONTRACT - Rev. 07/27/2005]. 
  
 ARTICLE I.2
AUTHORIZED SUBSTITUTION OF CLAUSES 
  
 ARTICLE I.1. of this
SECTION is hereby modified as follows: 
  
 FAR Clauses
52.219-9, Small Business Subcontracting Plan (July 2005), and 52.219-16, Liquidated Damages — Subcontracting Plan (January 1999) are deleted in their entirety. 
  
 FAR Clause 52.232-20, Limitation Of Cost (April 1984), is deleted in its entirety and FAR Clause 52.232-22,
Limitation Of Funds (April 1984) is substituted therefor. [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 

  

	 	(2)	FAR Clause 52.215-17, Waiver of Facilities Capital Cost of Money (October 1997). 

  

	 	(3)	FAR Clause 52.224-1, Privacy Act Notification (April 1984). 

  

	 	(4)	FAR Clause 52.224-2, Privacy Act (April 1984). 

  

	 	(5)	FAR Clause 52.227-14, Rights in Data - General (June 1987). 

  

	 	(6)	FAR Clause 52.242-3, Penalties for Unallowable Costs (May 2001). 

  

 30 

 Contract No. HHSN261200655000C 
  

	b.	DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CHAPTER 3) CLAUSES: 

  

	 	(1)	HHSAR Clause 352.223-70, Safety and Health (January 2001). [This clause is provided in full text in Section J - Attachments.] 

  

	 	(2)	HHSAR Clause 352.224-70, Confidentiality of Information (March 2005). 

  

	c.	NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES: 

  
 The following clauses are attached and made a part of this contract: 
  

	 	(1)	NIH (RC)-7, Procurement of Certain Equipment (April 1984) (OMB Bulletin 81-16). 

  
 ARTICLE 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: 
  

	a.	FAR Clause 52.222-39, Notification Of Employee Rights Concerning Payment Of Union Dues Or Fees (December 2004) 

  

	 	(a)	Definition. As used in this clause— 

  
 United States means the 50 States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin
Islands, and Wake Island. 
  

	 	(b)	Except as provided in paragraph (e) of this clause, during the term of this contract, the Contractor shall post a notice, in the form of a poster, informing employees of their
rights concerning union membership and payment of union dues and fees, in conspicuous places in and about all its plants and offices, including all places where notices to employees are customarily posted. The notice shall include the following
information (except that the information pertaining to National Labor Relations Board shall not be included in notices posted in the plants or offices of carriers subject to the Railway Labor Act, as amended (45 U.S.C. 151-188)).

  
 Notice to Employees 
  
 Under Federal law, employees cannot be required to join a union or maintain
membership in a union in order to retain their jobs. Under certain conditions, the law permits a union and an employer to enter into a union-security agreement requiring employees to pay uniform periodic dues and initiation fees. 
  

 31 

 Contract No. HHSN261200655000C 
  
 However, employees who are not union members can object to the use of their payments for certain purposes and can only be
required to pay their share of union costs relating to collective bargaining, contract administration, and grievance adjustment. 
  
 If you do not want to pay that portion of dues or fees used to support activities not related to collective bargaining, contract administration, or
grievance adjustment, you are entitled to an appropriate reduction in your payment. If you believe that you have been required to pay dues or fees used in part to support activities not related to collective bargaining, contract administration, or
grievance adjustment, you may be entitled to a refund and to an appropriate reduction in future payments. 
  
 For further information concerning your rights, you may wish to contact the National Labor Relations Board (NLRB) either at one of its Regional offices or
at the following address or toll free number: 
  
 National Labor
Relations Board 
 Division of Information 
 1099 14th Street, N.W. 
 Washington, DC 20570 
 1-866-667-6572 
 1-866-316-6572 (TTY)

  
 To locate the nearest NLRB office, see
NLRB’s website at http://www.nlrb.gov. 
  

	(c)	The Contractor shall comply with all provisions of Executive Order 13201 of February 17, 2001, and related implementing regulations at 29 CFR part 470, and orders of the
Secretary of Labor. 

  

	(d)	In the event that the Contractor does not comply with any of the requirements set forth in paragraphs (b), (c), or (g), the Secretary may direct that this contract be cancelled,
terminated, or suspended in whole or in part, and declare the Contractor ineligible for further Government contracts in accordance with procedures at 29 CFR part 470, Subpart B—Compliance Evaluations, Complaint Investigations and Enforcement
Procedures. Such other sanctions or remedies may be imposed as are provided by 29 CFR part 470, which implements Executive Order 13201, or as are otherwise provided by law. 

  

 32 

 Contract No. HHSN261200655000C 
  

	(e)	The requirement to post the employee notice in paragraph (b) does not apply to— 

  

	 	(1)	Contractors and subcontractors that employ fewer than 15 persons; 

  

	 	(2)	Contractor establishments or construction work sites where no union has been formally recognized by the Contractor or certified as the exclusive bargaining representative of the
Contractor’s employees; 

  

	 	(3)	Contractor establishments or construction work sites located in a jurisdiction named in the definition of the United States in which the law of that jurisdiction forbids enforcement
of union-security agreements; 

  

	 	(4)	Contractor facilities where upon the written request of the Contractor, the Department of Labor Deputy Assistant Secretary for Labor-Management Programs has waived the posting
requirements with respect to any of the Contractor’s facilities if the Deputy Assistant Secretary finds that the Contractor has demonstrated that— 

  

	 	(i)	The facility is in all respects separate and distinct from activities of the Contractor related to the performance of a contract; and 

  

	 	(ii)	Such a waiver will not interfere with or impede the effectuation of the Executive order; or 

  

	 	(5)	Work outside the United States that does not involve the recruitment or employment of workers within the United States. 

  

	(f)	The Department of Labor publishes the official employee notice in two variations; one for contractors covered by the Railway Labor Act and a second for all other contractors. The
Contractor shall— 

  

	 	(1)	Obtain the required employee notice poster from the Division of Interpretations and Standards, Office of Labor-Management Standards, U.S. Department of Labor, 200 Constitution
Avenue, NW, Room N-5605, Washington, DC 20210, or from any field office of the Department’s Office of Labor-Management Standards or Office of Federal Contract Compliance Programs; 

  

	 	(2)	Download a copy of the poster from the Office of Labor-Management Standards website at http://www.olms.dol.gov; or 

  

	 	(3)	Reproduce and use exact duplicate copies of the Department of Labor’s official poster. 

  

	(g)	 The Contractor shall include the substance of this clause in every subcontract or purchase order that exceeds the simplified acquisition threshold, entered 

  

 33 

 Contract No. HHSN261200655000C 
  

	 	 
into in connection with this contract, unless exempted by the Department of Labor Deputy Assistant Secretary for Labor-Management Programs on account of
special circumstances in the national interest under authority of 29 CFR 470.3(c). For indefinite quantity subcontracts, the Contractor shall include the substance of this clause if the value of orders in any calendar year of the subcontract is
expected to exceed the simplified acquisition threshold. Pursuant to 29 CFR part 470, Subpart B—Compliance Evaluations, Complaint Investigations and Enforcement Procedures, the Secretary of Labor may direct the Contractor to take such action in
the enforcement of these regulations, including the imposition of sanctions for noncompliance with respect to any such subcontract or purchase order. If the Contractor becomes involved in litigation with a subcontractor or vendor, or is threatened
with such involvement, as a result of such direction, the Contractor may request the United States, through the Secretary of Labor, to enter into such litigation to protect the interests of the United States. 

  

 34 

 Contract No. HHSN261200655000C 
  
 PART III 
  
 SECTION J - LIST OF ATTACHMENTS 
  
 The following documents are attached and incorporated in this contract: 
  

	5.	Sample Contract Work Assignment, 3 pages. 

  

	6.	Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-1 (5/97), 5 pages. 

  

	7.	Financial Report of Individual Project/Contract, NIH 2706, (5/97), 1 page. 

  

	8.	Instructions for Completing form NIH 2706, Financial Report of Individual Project/Contract, (5/97), 3 pages. 

  

	9.	Privacy Act System of Records, Number 09-25-0200, as cited in the Federal Register Notice issued in Volume 62, Number 66, pages 16596-16602, dated 4/7/97. 

 

	10.	Safety and Health, HHSAR Clause 352.223-70, (1/01), 1 page. 

  

	11.	Procurement of Certain Equipment, NIH(RC)-7, 4/1/84, 1 page. 

  

	12.	Government Property - Schedule I-B, 1 page. 

  

	13.	Government Property - Schedule II-A, 7 pages 

  

	14.	Report of Government Owned, Contractor Held Property, 1 page. 

  

 35 

 Contract No. HHSN261200655000C 
  
 PART IV 
  
 SECTION K - REPRESENTATIONS AND CERTIFICATIONS 
  
 The following documents are incorporated by reference in this contract: 
  

	1.	Annual Representations and Certifications completed and located at the Online Representations and Certifications Application (ORCA) website. [This includes the changes identified in
paragraph (b) of the FAR provision 52.204-8, Annual Representations and Certifications, contained in the contractor’s proposal.] 

  
 END of the SCHEDULE 
 (CONTRACT)

  

 36 

 Contract No. HHSN261200655000C 
  
 CONTRACT WORK ASSIGNMENT (W.A.) 
  
 Contractor: _______________________________________________________________________W.A. Title: 

 

	Contract	No: _________________________________________________________________________ 

  
 W.A. No: ___________________________ Modification No.: _________________________W.A. Originator:

  
 Contracted Task Area:
___________________________________________________________ Date Prepared: 
  

  
 Part I. INITIATOR’S REQUEST 
  

	 	A.	Period of Performance: From
                             to
                             

  

	 	B.	Task Description 

  

	 	C.	Task Leader 

  

	 	D.	Deliverables 

  

	 	E.	W.A. Response Due Date: 

  

					
	Contract Work Assignment	  	 	  	ATTACHMENT 1
	 	  	1	  	Page 1

 Contract No. HHSN261200655000C 
  
 CONTRACT WORK ASSIGNMENT (W.A.) 
  
 Contractor: ____________________________________________________________________ Contract No: 
  
 W.A. No: ___________________________ Modification No:
_________________________ Date Prepared: 
  

  
 PART II. CONTRACTOR’S RESPONSE TO W.A. REQUEST 
  
 (The Contractor may attach additional sheets to this form to present
requested data.) 
  

	 	A.	Estimated Cost and Effort 

  

	 	1.	Labor hours - list W.A. leader, specific individuals to be assigned, labor category, and estimated hours for each. 

	 	2.	Labor costs - list by labor category and total. 

	 	3.	Employee benefits. 

	 	4.	Direct materials 

	 	5.	Travel 

	 	6.	Subcontracts 

	 	7.	Other direct costs 

	 	8.	Indirect costs 

	 	9.	Total estimated costs for this Order 

  

	 	B.	Detailed description of the approach to be used and of the deliverable(s). (Be specific.) 

  

  
 APPROVAL
TO PROCEED: The Contractor shall not exceed the estimated labor hours, estimated W.A. amount, or change the W.A. leader without the prior written approval of the Project Officer and the Contracting Officer. 
  

  

			
	 l.       For the Contractor: ____________________________________________________________
	  	 Date:

	(Signature)	  	 
	          Typed name:
	  	 
		
	 2.      For the Government: ___________________________________________________________
	  	 Date:

	(Project Officer)	  	 
		
	                                        
       ___________________________________________________________
	  	 Date:

		
	(Contracting Officer)	  	 

  

					
	Contract Work Assignment	  	 	  	ATTACHMENT 1
	 	  	2	  	 

 Contract No. HHSN261200655000C 
  
 CONTRACT WORK ASSIGNMENT (W.A.) 
  
 Contractor: _____________________________________________________________________ Contract No: 
  
 W.A. No: ___________________________ Modification No:
_________________________ Date Prepared: 
  
 PART
III. CONTRACTOR’S REPORT OF W.A. PERFORMANCE 
  
 (The
Contractor may attach additional sheets to this form to present the requested data.) 
  

	 	A.	Actual Cost and Effort 

  

	 	1.	Labor hours - list specific assigned individuals, labor category, and actual hours worked. 

  

	 	2.	Labor costs - list labor category, individual, and total amount. 

  

	 	3.	Employee benefits 

  

	 	4.	Direct Materials 

  

	 	5.	Travel 

  

	 	6.	Subcontracts 

  

	 	7.	Other direct costs 

  

	 	8.	Indirect costs 

  

	 	9.	Total costs for this W.A. 

  

	 	B.	Report of Deliverables 

  

  
 REVIEW AND APPROVAL OF SATISFACTORY PERFORMANCE 

 
 The signatures below indicate that the services/products required under Work Assignment
No.                  have been delivered, received and satisfactorily meet the requirements of this Work Assignment. 
  

  

			
	 l.       For the Contractor: ____________________________________________________________
	  	Date:
	(Signature)	  	 
	          Typed name:
	  	 
		
	 2.      For the Government: ___________________________________________________________
	  	Date:
	(Project Officer)	  	 
		
	                                        
       ___________________________________________________________
	  	 Date:

		
	(Contracting Officer)	  	 

  

					
	Contract Work Assignment	  	 	  	ATTACHMENT 1
	 	  	3	  	 

 Contract No. HHSN261200655000C 
  
 INVOICE/FINANCING REQUEST INSTRUCTIONS 
 FOR NIH COST-REIMBURSEMENT TYPE CONTRACTS, NIH(RC)-1 
  
 General: The contractor shall submit claims for reimbursement in the manner and format described herein and as illustrated in the sample invoice/financing request. 
  
 Format: Standard Form 1034, “Public Voucher for Purchases and Services Other Than
Personal,” and Standard Form 1035, “Public Voucher for Purchases and Services Other Than Personal— Continuation Sheet,” or reproduced copies of such forms marked ORIGINAL should be used to submit claims for reimbursement. In lieu
of SF-1034 and SF-1035, claims may be submitted on the payee’s letter-head or self-designed form provided that it contains the information shown on the sample invoice/financing request. 
  
 Number of Copies: As indicated in the Invoice Submission Clause in the contract.

  
 Frequency: Invoices/financing requests submitted in accordance with the
Payment Clause shall be submitted monthly unless otherwise authorized by the contracting officer. 
  
 Cost Incurrence Period: Costs incurred must be within the contract performance period or covered by precontract cost provisions. 
  
 Billing of Costs Incurred: If billed costs include: (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. 
  

					
	Contract Work Assignment	  	 	  	ATTACHMENT 1
	 	  	4	  	 

 Contract No. HHSN261200655000C 
  
 Invoice/Financing Request Identification: Each invoice/financing request shall be identified as either: 
  

	(a)	Interim Invoice/Contract Financing Request – These are interim payment requests submitted during the contract performance period. 

  

	(b)	Completion Invoice – The completion invoice is submitted promptly upon completion of the work; but no later than one year from the contract completion date, or within
120 days after settlement of the final indirect cost rates covering the year in which this contract is physically complete (whichever date is later). The completion invoice should be submitted when all costs have been assigned to the contract and
all performance provisions have been completed. 

  

	(c)	Final Invoice – A final invoice may be required after the amounts owed have been settled between the Government and the contractor (e.g., resolution of all suspensions
and audit exceptions). 

  
 Preparation and Itemization of the
Invoice/Financing Request: The contractor shall furnish the information set forth in the explanatory notes below. These notes are keyed to the entries on the sample invoice/financing request. 
  

	(a)	Designated Billing Office Name and Address – Enter the designated billing office name and address, identified in the Invoice Submission Clause of the contract, on all
copies of the invoice/financing request. 

  

	(b)	Invoice/Financing Request Number – Insert the appropriate serial number of the invoice/financing request. 

  

	(c)	Date Invoice/Financing Request Prepared – Insert the date the invoice/financing request is prepared. 

  

	(d)	Contract Number, ADB Number and Date – Insert both the contract number and the ADB number (which appears in the upper left hand corner of the face page of the contract),
and the effective date of the contract. 

  

	(e)	Payee’s Name and Address – Show the contractor’s name (as it appears in the contract), correct address, and the title and phone number of the responsible
official to whom payment is to be sent. When an approved assignment has been made by the contractor, or a different payee has been designated, then insert the name and address of the payee instead of the contractor. 

  

	(f)	Total Estimated Cost of Contract – Insert the total estimated cost of the contract, exclusive of fixed-fee. For incrementally funded contracts, enter the amount
currently obligated and available for payment. 

  

					
	NIH (RC) - 1	  	 	  	ATTACHMENT 2
	 Rev. 11/2003
	  	 	  	Page 2

 Contract No. HHSN261200655000C 
  

	(g)	Total Fixed-Fee – Insert the total fixed-fee (where applicable). For incrementally funded contracts, enter the amount currently obligated and available for payment.

  

	(h)	Billing Period – Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.

  

	(i)	Amount Billed for Current Period – Insert the amount billed for the major cost elements, adjustments, and adjusted amounts for the period. 

  

	(j)	Cumulative Amount from Inception – Insert the cumulative amounts billed for the major cost elements and adjusted amounts claimed during this contract.

  

	(k)	Direct Costs – Insert the major cost elements. For each element, consider the application of the paragraph entitled “Costs Requiring Prior Approval” on page 1
of these instructions. 

  

	 	(l)	Direct Labor – Include salaries and wages paid (or accrued) for direct performance of the contract. 

  

	 	(2)	Fringe Benefits – List any fringe benefits applicable to direct labor and billed as a direct cost. Fringe benefits included in indirect costs should not be identified
here. 

  

	 	(3)	Accountable Personal Property – Include permanent research equipment and general purpose equipment having a unit acquisition cost of $1,000 or more and having an
expected service life of more than two years, and sensitive property regardless of cost (see the DHHS Contractor’s Guide for Control of Government Property). Show permanent research equipment separate from general purpose equipment.
Prepare and attach the NIH Form entitled, “Report of Government Owned, Contractor Held Property,” in accordance with the following instructions: 

  
 List each item for which reimbursement is requested. A reference shall be made to the following (as applicable): 

 

	 	•	 	The item number for the specific piece of equipment listed in the Property Schedule. 

  

	 	•	 	The COA letter and number, if the equipment is not covered by the Property Schedule. 

  

	 	•	 	An asterisk (*) shall precede the item if the equipment is below the approval level. 

  
 Further itemization of invoices/financing requests shall only be required for items having specific limitations set forth in
the contract. 
  

	 	(4)	Materials and Supplies – Include equipment with unit costs of less than $1,000 or an expected service life of two years or less, and consumable material and supplies
regardless of amount. 

  

					
	NIH (RC) - 1	  	 	  	ATTACHMENT 2
	 Rev. 11/2003
	  	 	  	Page 3

 Contract No. HHSN261200655000C 
  

	 	(5)	Premium Pay – List remuneration in excess of the basic hourly rate. 

  

	 	(6)	Consultant Fee – List fees paid to consultants. Identify consultant by name or category as set forth in the contract’s advance understanding or in the COA letter,
as well as the effort (i.e., number of hours, days, etc.) and rate being billed. 

  

	 	(7)	Travel – Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its territories and possessions. However, for an
organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel. 

  

	 	(8)	Subcontract Costs – List subcontractor(s) by name and amount billed. 

  

	 	(9)	Other – List all other direct costs in total unless exceeding $1,000 in amount. If over $1,000, list cost elements and dollar amounts separately. If the contract
contains restrictions on any cost element, that cost element must be listed separately. 

  

	(l)	Cost of Money (COM) – Cite the COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed. 

  

	(m)	Indirect Costs — Overhead – Identify the cost base, indirect cost rate, and amount billed for each indirect cost category. 

  

	(n)	Fixed-Fee Earned – Cite the formula or method of computation for the fixed-fee (if any). The fixed-fee must be claimed as provided for by the contract.

  

	(o)	Total Amounts Claimed – Insert the total amounts claimed for the current and cumulative periods. 

  

	(p)	Adjustments – Include amounts conceded by the contractor, outstanding suspensions, and/or disapprovals subject to appeal. 

  

	(q)	Grand Totals 

  
 The contracting officer may require the contractor to submit detailed support for costs claimed on one or more interim invoices/financing requests. 
  

					
	NIH (RC) - 1	  	 	  	ATTACHMENT 2
	 Rev. 11/2003
	  	 	  	Page 4

 Contract No. HHSN261200655000C 
  
 SAMPLE INVOICE/FINANCING REQUEST 
  

			
	 (a)    Billing Office Name and Address
	  	 (b)    Invoice/Financing Request No.

		
	 NATIONAL INSTITUTES OF HEALTH
	  	 
	 National Cancer Institute, RCB
	  	 (c)    Date Invoice Prepared

	 EPS, Room                 
	  	 
		
	 6120 EXECUTIVE BLVD MSC
	  	 
	 Bethesda, MD 20892-                     
	  	 (d)    Contract No., ADB No., and Effective Date

		
	 (e)    Payee’s Name and Address
	  	 (f)     Total Estimated Cost of Contract

		
	 ABC CORPORATION
	  	 
	 100 Main Street
	  	 
	 Anywhere, U.S.A. zip code
	  	 (g)    Total Fixed Fee

  
 Attention: Name, Title, and Phone
Number of Official to Whom Payment is Sent 
  

	(h)	This invoice/financing request represents reimbursable costs from Aug. l, 2003 through Aug. 31, 2003 

  

								
	 	  	(i) Amount Billed
for Current Period

	  	(j) Cumulative Amount
From Inception

	 
	 (k)    Direct Costs
	  	 	 	  	 	 	 
	 (1)    Direct Labor
	  	$	3,400	  	$	6,800	 
	 (2)    Fringe Benefits
	  	 	600	  	 	1,200	 
	 (3)    Accountable Personal Property
(Attach Form HHS-565)
Permanent Research
	  	 	3,000	  	 	6,000	 
	 General Purpose
	  	 	2,000	  	 	2,000	 
	 (4)    Materials and Supplies
	  	 	2,000	  	 	4,000	 
	 (5)    Premium Pay
	  	 	100	  	 	150	 
	 (6)    Consultant Fee-Dr. Jones 1 day @ 100 (COA #3)
	  	 	100	  	 	100	 
	 (7)    Travel (Domestic)
	  	 	200	  	 	200	 
	            (Foreign)
	  	 	200	  	 	200	 
	 (8)    Subcontract Costs
	  	 	-0-	  	 	-0-	 
	 (9)    Other
	  	 	-0-	  	 	-0-	 
	 	  	
	
	  	
	
	

	 Total Direct Costs
	  	$	11,600	  	$	20,650	 
	 (l)     Cost of Money (Factor) of (Appropriate Base)
	  	 	2,400	  	 	3,600	 
	 (m)   Indirect Costs — Overhead             % of Direct
Labor or Other Base (Formula)
	  	 	4,000	  	 	6,000	 
	 (n)    Fixed-Fee Earned (Formula)
	  	 	700	  	 	1,400	 
	 	  	
	
	  	
	
	

	 (o)    Total Amount Claimed
	  	$	18,700	  	$	31,650	 
	 (p)    Adjustments
	  	 	 	  	 	 	 
	 Outstanding Suspensions
	  	 	 	  	 	(1,700	)
	 (q)    Grand Totals
	  	$	18,700	  	$	29,950	 

  
 “I certify that all payments
requested are for appropriate purposes and in accordance with the contract.” 
  
  

			
	 	 	 
	 Name of Official)
	 	 (Title)

  

					
	 NIH(RC) -1
 Rev.
11/2003
	  	 	  	 ATTACHMENT 2
 Page 5

 Contract No. HHSN261200655000C 
  

									
	 National Institutes of Health
  
 FINANCIAL REPORT OF INDIVIDUAL
 PROJECT/CONTRACT, NIH FORM 2706
	  	Project Task: Laboratory Support for Processing and Storage of Biomedical Specimens for Persons at High Risk of Cancer	  	Contract No.:
N02-CP-65500	  	Date of Report:	  	0990-0134
0990-0131
	 Note:  Complete this Form in Accordance with Accompanying Instructions.
	  	Reporting Period:	  	Contractor Name and Address:

  

																				
	 Expenditure
Category

	  	Percentage of
Effort/Hours

	  	Cumulative
Incurred
Cost at
End of
Prior
Period

	  	Incurred
Cost —
Current
Period

	  	Cumulative
Cost to
Date (D +
E)

	  	Estimated
Cost to
Complete

	  	Estimated
Cost at
Completion
(F + G)

	  	Negotiated
Contract
Amount

	  	Variance
(Over or
Under)
(I - H)

	  	Negotiated

	  	Actual

	  	  	  	  	  	  	  
	A	  	B	  	C	  	D	  	E	  	F	  	G	  	H	  	I	  	J
	 Direct Labor
	  	176320	  	 	  	 	  	 	  	 	  	 	  	 	  	$	3,719,882	  	 
	 Materials & Supplies
	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	1,398,285	  	 
	 Travel
	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	26,589	  	 
	 Equipment
	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	999,759	  	 
	 Other Direct Costs
	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	673,798	  	 
	 Total Direct Costs:
	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	$	6,818,313	  	 
	 Overhead
	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	5,282,234	  	 
	 G&A
	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	1,210,055	  	 
	 Total Proposed Costs:
	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	$	13,310,602	  	 
	 Fixed Fee
	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	 	791,982	  	 
	 Total CPFF
	  	 	  	 	  	 	  	 	  	 	  	 	  	 	  	$	14,102,584	  	 

  

			
	 NIH 2706 (5/92) (Formerly HHS-646)
	 	ATTACHMENT

 Contract No. HHSN261200655000C 
  
 INSTRUCTIONS FOR COMPLETING FORM NIH 2706 
 “FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT” 
  
 GENERAL INFORMATION 
  
 Purpose.
Form NIH 2706 is designed to: (1) provide a management tool for use by be NIH in monitoring the application of financial and personnel resources to the NIH contracts; (2) provide contractors with financial and personnel management data
which is usable in their management processes; (3) promptly indicate potential areas of contract underruns or overruns by making possible comparisons of actual performance and projections with prior estimates on individual elements of cost and
personnel; and (4) obtain contractor’s analyses of cause and effect of significant variations between actual and prior estimates of financial and personnel performance. 
  
 REPORTING REQUIREMENTS 
  
 Scope. The specific cost and personnel elements to be reported shall be established by mutual agreement prior to award. The Government may require the contractor
to provide detailed documentation to support any element(s) on one or more financial reports. 
  
 Number of Copies and Mailing Address. An original and two (2) copies of the report(s) shall be sent to the contracting officer at the address shown on the face page of the contract, no later than 30
working days after the end of the period reported. However, the contract may provide for one of the copies to be sent directly to the project officer. 
  
 REPORTING STATISTICS 
  
 A modification which extends the period of performance of an existing contract will not require reporting on a separate Form NIH 2706, except where it is determined by the contracting officer that separate reporting
is necessary. Furthermore, when incrementally funded contracts are involved, each separate allotment is not considered a separate contract entity (only a funding action). Therefore, the statistics under incrementally funded contracts should be
reported cumulatively from the inception of the contract through completion. 
  
 Definitions and Instructions for Completing Form NIH 2706. For the purpose of establishing expenditure categories in Column A, the following definitions and instructions will be utilized. Each contract will specify the categories to
be reported. 
  

	(1)	Key Personnel. Include key personnel regardless of annual salary rates. All such individuals should be listed by names and job titles on a separate line including those whose
salary is not directly charged to the contract but whose effort is directly associated with the contract. The listing must be kept up to date. 

  

	(2)	Personnel—Other. List as one amount unless otherwise required by the contract. 

  

					
	Form NIH 2706, Instructions	  	 	  	Page 1
	 (5/97)
	  	 	  	Attachment 4

 Contract No. HHSN261200655000C 
  

	(3)	Fringe Benefits. Include allowances and services provided by the contractor to employees as compensation in addition to regular salaries and wages. If a fringe benefit
rate(s) has been established, identify the base, rate, and amount billed for each category. If a rate has not been established, the various fringe benefit costs may be required to be shown separately. Fringe benefits which are included in the
indirect cost rate should not be shown here. 

  

	(4)	Accountable Personal Property. Include nonexpendable personal property with an acquisition cost of $1,000 or more and with an expected useful life of two or more years, and
sensitive items regardless of cost. Form HHS 565, “Report of Accountable Property,” must accompany the contractor’s public voucher (SF 1034/SF 1035) or this report if not previously submitted. See “Contractor’s Guide for
Control of Government Property.” 

  

	(5)	Supplies. Include the cost of supplies and material and equipment charged directly to the contract, but excludes the cost of nonexpendable equipment as defined in
(4) above. 

  

	(6)	Inpatient Care. Include costs associated with a subject while occupying a bed in a patient care setting. It normally includes both routine and ancillary costs.

  

	(7)	Outpatient Care. Include costs associated with a subject while not occupying a bed. It normally includes ancillary costs only. 

  

	(8)	Travel. Include all direct costs of travel, including transportation, subsistence and miscellaneous expenses. Travel for staff and consultants shall be shown separately.
Identify foreign and domestic travel separately. If required by the contract, the following information shall be submitted: (i) Name of traveler and purpose of trip; (ii) Place of departure, destination and return, including time and
dates; and (iii) Total cost of trip. 

  

	(9)	Consultant Fee. Include fees paid to consultant(s). Identify each consultant with effort expended, billing rate, and amount billed. 

  

	(10)	Premium Pay. Include the amount of salaries and wages over and above the basic rate of pay. 

  

	(11)	Subcontracts. List each subcontract by name and amount billed. 

  

	(12)	Other Costs. Include any expenditure categories for which the Government does not require individual line item reporting. It may include some of the above categories.

  

	(13)	Overhead/Indirect Costs. Identify the cost base, indirect cost rate, and amount billed for each indirect cost category. 

  

	(14)	General and Administrative Expense. Cite the rate and the base. In the case of nonprofit organizations, this item will usually be included in the indirect cost.

  

	(15)	Fee. Cite the fee earned, if any. 

  

	(16)	Total Costs to the Government. 

  

							
	Form NIH 2706, Instructions	  	 	  	 	  	Page 2
	 (5/97)
	  	 	  	 	  	Attachment 4

 Contract No. HHSN261200655000C 
  
 PREPARATION INSTRUCTIONS 
  
 These instructions are keyed to the Columns on Form NIH 2706. 
  
 Column A—Expenditure Category. Enter the expenditure categories required by the contract. 
  
 Column B—Percentage of Effort/Hours Negotiated. Enter the percentage of effort or number of hours agreed to during contract
negotiations for each labor category listed in Column A. 
  
 Column
C—Percentage of Effort/Hours-Actual. Enter the cumulative percentage of effort or number of hours worked by each employee or group of employees listed in Column A. 
  
 Column D—Cumulative Incurred Cost at End of Prior Period. Enter the cumulative incurred costs up to the end of the prior
reporting period. This column will be blank at the time of the submission of the initial report. 
  
 Column E—Incurred Cost-Current Period. Enter the costs which were incurred during the current period. 
  
 Column F—Cumulative Incurred Cost to Date. Enter the combined total of Columns D and E. 
  
 Column G—Estimated Cost to Complete. Make entries only when the contractor estimates that a particular expenditure category will
vary from the amount negotiated. Realistic estimates are essential. 
  
 Column
H—Estimated Costs at Completion. Complete only if an entry is made in Column G. 
  
 Column I—Negotiated Contract Amount. Enter in this column the costs agreed to during contract negotiations for all expenditure categories listed in Column A. 
  
 Column J—Variance (Over or Under). Complete only if an entry is made in Column H.
When entries have been made in Column H, this column should show the difference between the estimated costs at completion (Column H) and negotiated costs (Column I). When a line item varies by plus or minus 10 percent, i.e., the percentage arrived
at by dividing Column J by Column I, 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. List any modification in the amount negotiated for an
item since the preceding report in the appropriate cost category. 
  
 Expenditures Not Negotiated. List any expenditure for an item for which no amount was negotiated (e.g., at the discretion of the contractor in performance of its contract) in the appropriate cost category and complete all columns
except for I. Column J will of course show a 100 percent variance and will be explained along with those identified under J above. 
  

					
	Form NIH 2706, Instructions	  	 	  	Page 3
	 (5/97)
	  	 	  	Attachment 4

 Contract No. HHSN261200655000C 
  
 PRIVACY ACT SYSTEM OF RECORDS 
  

[Federal Register: April 7, 1997 (Volume 62, Number 66)] 
 [Notices]

 [Page 16596-16602] 
 From the Federal Register Online via GPO
Access [wais.access.gpo.gov] 
 [DOCID:fr07ap97_dat-89] 
  
 [[Page 16596]] 
  
 DEPARTMENT OF HEALTH AND HUMAN SERVICES 
  
 National Institutes of Health 
  
 Privacy Act of 1974; New System of Records 
  
 agency: National Institutes of Health, HHS. 
  
 action: Notification of a new system of records. 
  
 summary: In accordance with the requirements of the Privacy Act, the National Institutes of Health (NIH) is publishing a notice of a new system of records, 09-25-0200,
“Clinical, Epidemiologic and Biometric Studies of the National Institutes of Health (NIH), HHS/NIH/OD.” This system notice serves as an umbrella system for most NIH clinical, epidemiologic and biometric research studies. Thirty-eight
existing NIH system notices were subsumed under this notice (listed in the system notice under System Manager(s)), to reduce the number and avoid future proliferation of like system notices. We are also proposing routine uses for this new system;
with two exceptions, these routine uses were already contained in the preceding system notices. The first new routine use will allow disclosure to authorized organizations which provide health services to subject individuals or provide third-party
reimbursement or fiscal intermediary functions. The purpose of the disclosure is to plan for or provide such services, bill or collect third-party reimbursements. The second new routine use will allow disclosure 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. 
  
 dates: NIH invites interested parties to submit comments on the proposed internal and routine uses on or before May 7, 1997. NIH has sent a report of a New System to the Congress and to the Office of Management
and Budget (OMB) on November 6, 1996. This system of records will be effective 40 days from the date of publication unless NIH receives comments on the routine uses which would result in a contrary determination. 
  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 address: Please submit comments to: NIH Privacy Act Officer, Building 31, Room 1B05, 31 Center Drive MSC 2075, Bethesda, MD 20892-2075, 301-
496-2832. 
  
 Comments received will be available for inspection
at this same address from 9 a.m. to 3 p.m., Monday through Friday. 
  
 for further
information contact: NIH Privacy Act Officer, Building 31, Room 1B05, 31 Center Drive MSC 2075, Bethesda, MD 20892-2075, 301-496- 2832. 
  
 The numbers listed above are not toll free. 
  
 supplementary information: The National Institutes of Health (NIH) proposes to establish a new system of records: 09-25-0200, “Clinical, Epidemiologic and Biometric
Studies of the National Institutes of Health (NIH), HHS/NIH/OD.” This umbrella system of records will be used by NIH staff to document, track, monitor and evaluate NIH clinical, epidemiologic and biometric research activities. This inclusive
system notice will achieve agency administrative efficiencies, avoiding confusion created by the current fragmented pool of Institute, Center and Division (ICD) system notices. Because of its unique organizational structure, NIH has, over the recent
decades, experienced a proliferation of almost identical system notices that differ only by disease/disorder under study or ICD interest. This system notice subsumes thirty-eight existing system notices and will offer coverage for research not
currently covered by an appropriate system notice. The consolidation of similar research systems of records into one generic-type notice will also serve the public interest. It will alleviate burden on the public associated with multiple attempts at
notification, access and correction of record information when individuals are not sure which research system notice applied to their study participation. 
  
 The system will comprise records about individuals as relevant to a particular research study. Examples include, but are not limited to: Name, study
identification number, address, relevant telephone numbers, Social Security Number (voluntary), driver’s license number, date of birth, weight, height, sex, race; medical, psychological and dental information, laboratory and diagnostic testing
results; registries; social, economic and demographic data; health services utilization; insurance and hospital cost data, employers, conditions of the work environment, exposure to hazardous substances/compounds; information pertaining to stored
biologic specimens (including blood, urine, tissue and genetic materials), characteristics and activities of health care providers and educators and trainers (including curriculum vitae); and associated correspondence. The amount of information
recorded on each individual will be only that which is necessary to accomplish the purpose of the system. 
  
 The records in this system will be maintained in a secure manner compatible with their content and use. NIH and contractor staff will be required to
adhere to the provisions of the Privacy Act and the HHS Privacy Act Regulations. The System Manager will control access to the data. Only authorized users whose official duties require the use of such information will have regular access to the
records in this system. Authorized users are HHS employees, and contractors responsible for implementing the research. 
  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 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. Manual and computerized records will be maintained in accordance 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, the Department’s Automated Information System Security Program Handbook, and the National Institute of Standards and Technology Federal Information Processing Standards (FIPS Pub. 41 and FIPS
Pub. 31). 
  
 Data on computer files is accessed by keyword known
only to authorized users. Access to information is thus limited to those with a need to know. Rooms where records are stored are locked when not in use. During regular business hours rooms are unlocked but are controlled by on-site personnel.
Researchers authorized to conduct research on biological specimens will typically access to 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. All authorized users of personal information in connection with the performance of their jobs protect information from public view and from unauthorized personnel entering an unsupervised office. Depending upon the sensitivity of the
information in the record, additional safeguard measures are employed. 
  
 The routine uses proposed for this system are compatible with the stated purposes of the system. The first routine use permits disclosure of a record for an authorized research purpose under specified conditions. The second routine use
permitting disclosure to a congressional office is proposed to allow subject individuals to obtain assistance from their representatives in Congress, should they so desire. Such 
  
 [[Page 16597]] 
  
 disclosure would be made only pursuant to a request of the individual. The third routine use allows disclosure to the Department of Justice for use in litigation. The
fourth routine use allows disclosure of records to contractor, grantee, experts, consultants 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. The fifth routine use allows disclosure to certain relevant third parties (e.g., relatives, prior employees, Motor Vehicle Administration, State vita statistics offices) when necessary to obtain
information on morbidity and mortality experiences and to locate individuals for follow-up studies. The sixth routine use allows disclosure to tumor registries for maintenance of health statistics. The seventh routine use allows the PHS to 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, or to disclose such information to State or local public health departments under specified
circumstances. The eighth routine use allows disclosure of certain diseases and conditions, including infectious diseases, to appropriate representatives of State or Federal Government as required by State or Federal law. The ninth routine use
allows records to be disclosed to 

  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 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 tenth routine use allows disclosure to organizations deemed qualified by the Secretary, DHHS, to carry out quality
assessment, medical audits or utilization reviews. The eleventh routine use allows information to be disclosed 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. 
  
 The following notice is written in the present,
rather than future tense, in order to avoid the unnecessary expenditure of public funds to republish the notice after the system has become effective. 
  
 Dated: October 30, 1996. 
 Anthony L. Itteilag,

 Deputy Director for Management, National Institutes of Health. 
 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 

  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 birth, weight, height, sex, race; medical, psychological and dental information, laboratory and diagnostic testing results; registries;
social, economic and demographic data; health services utilization; insurance and hospital cost data, employers, conditions of the work environment, exposure to hazardous substances/compounds; information pertaining to stored biologic specimens
(including blood, urine, tissue and genetic materials), characteristics and activities of health care providers and educators and trainers (including curriculum vitae); and associated correspondence. 
  
 AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 
  
 “Research and Investigation,” “Appointment and Authority of
the Directors of the National Research Institutes,” “National Cancer Institute,” “National Eye Institute,” “National Heart, Lung and Blood Institute,” “National Institute on Aging,” “National
Institute on Alcohol Abuse and Alcoholism,” “National Institute on Allergy and Infectious Diseases,” “National Institute of Arthritis and Musculoskeletal and Skin Diseases,” “National Institute of Child Health and Human
Development,” “National Institute on Deafness and Other Communication Disorders,” “National Institute of Dental Research,” “National Institute of Diabetes, and Digestive and Kidney Diseases,” “National
Institute of Drug Abuse,” “National Institute of Environmental Health Sciences,” “National Institute of Mental Health,” “National Institute of Neurological Disorders and Stroke,” and the “National Center for
Human Genome Research,” of the Public Health Service Act. (42 U.S.C. 241, 242, 248, 281, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 285l, 285m, 285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.)

  
 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: 
  
 1. A record may be disclosed for a research purpose, when the Department: (A) has determined that the use or disclosure does not violate legal or policy limitations under which the record was provided, collected, or obtained; e.g.,
disclosure of alcohol or drug abuse patient records will be made only in accordance with the restrictions of confidentiality statutes and regulations 42 U.S.C. 241, 42 U.S.C. 290dd-2, 42 CFR part 2, and where applicable, no disclosures will be made
inconsistent with an authorization of confidentiality under 42 U.S.C. 241 and 42 CFR part 2a; (B) has determined that the research purpose (1) cannot be reasonably accomplished unless the 
  
 [[Page 16598]] 
  
 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 

  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 time at which removal or destruction can be accomplished consistent with the purpose of the research project, unless the recipient has
presented adequate justification of a research or health nature for retaining such information, and (3) make no further use or disclosure of the record except (a) in emergency circumstances affecting the health or safety of any individual,
(b) for use in another research project, under these same conditions, and with written authorization of the Department, (c) for disclosure to a property identified person for the purpose of an audit related to the research project, if
information that would enable research subjects to be identified is removed or destroyed at the earliest opportunity consistent with the purpose of the audit, or (d) when required by law; and (D) has secured a written statement attesting
to the recipient’s understanding of, and willingness to abide by, these provisions. 
  
 2. Disclosure may be made to a Member of Congress or to a Congressional staff member in response to an inquiry of the Congressional office made at the written request of the constituent about whom the record is
maintained. 
  
 3. The Department of Health and Human Services
(HHS) may disclose information from this system of records to the Department of Justice when: (a) The agency or any component thereof; or (b) any employee of the agency in his or her official capacity where the Department of Justice has
agreed to represent the employee; or (c) the United States Government, is a party to litigation or has an interest in such litigation, and by careful review, the agency determines that the records are both relevant and necessary to the
litigation and the use of such records by the Department of Justice is therefore deemed by the agency to be for a purpose that is compatible with the purpose for which the agency collected the records. 
  
 4. Disclosure may be made to agency contractors, grantees, experts,
consultants, collaborating researchers, or volunteers who have been engaged by the agency to assist in the performance of a service related to this system of records and who need to have access to the records in order to perform the activity.
Recipients shall be required to comply with the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m). 
  
 5. Information from this system may be disclosed to Federal agencies, State agencies (including the Motor Vehicle Administration and State vital
statistics offices, private agencies, and other third parties (such as current or prior employers, acquaintances, relatives), when necessary to obtain information on morbidity and mortality experiences and to locate individuals for follow-up
studies. Social Security numbers, date of birth and other identifiers may be disclosed: (1) To the National Center for Health Statistics to ascertain vital status through the National Death Index; (2) to the Health Care Financing Agency to
ascertain morbidities; and (3) to the Social Security Administration to ascertain disabilities and/or location of participants. Social Security numbers may also be given to other Federal agencies, and State and local agencies when necessary to
locating individuals for participation in follow-up studies. 
  
 6. Medical information may be disclosed in identifiable form to tumor registries for maintenance of health statistics, e.g., for use in epidemiologic studies. 
  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 7. (a). PHS may inform the sexual and/or needle-sharing partner(s) of a subject individual who is infected with the human
immunodeficiency virus (HIV) of their exposure to HIV, under the following circumstances: (1) The information has been obtained in the course of clinical activities at PHS facilities carried out by PHS personnel or contractors; (2) The PHS
employee or contractor has made reasonable efforts to counsel and encourage the subject individual to provide the information to the individual’s sexual or needle-sharing partner(s); (3) The PHS employee or contractor determines that the
subject individual is unlikely to provide the information to the sexual or needle-sharing partner(s) or that the provision of such information cannot reasonably be verified; and (4) The notification of the partner(s) is made, whenever possible,
by the subject individual’s physician or by a professional counselor and shall follow standard counseling practices. 
  
 (b). PHS may disclose information to State or local public health departments, to assist in the notification of the subject individual’s sexual
and/or needle-sharing partner(s), or in the verification that the subject individual has notified such sexual or needle-sharing partner(s). 
  
 8. Certain diseases and conditions, including infectious diseases, may be reported to appropriate representatives of State or Federal Government as
required by State or Federal law. 
  
 9. Disclosure may be made to
authorized organizations which provide health services to subject individuals or provide third-party reimbursement or fiscal intermediary functions, for the purpose of planning for or providing such services, billing or collecting third-party
reimbursements. 
  
 10. The Secretary may disclose information to
organizations deemed qualified to carry out quality assessment, medical audits or utilization reviews. 
  
 11. Disclosure may be made for the purpose of reporting child, elder or spousal abuse or neglect or any other type of abuse or neglect as required by
State or Federal law. 
  
 POLICIES AND PRACTICES FOR STORING, RETRIEVING,
ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: 
  
 STORAGE:

  
 Records may be stored on index cards, file folders, computer
tapes and disks (including optical disks), photography media, microfiche, microfilm, and audio and video tapes. For certain studies, factual data with study code numbers are stored on computer tape or disk, while the key to personal identifiers is
stored separately, without factual data, in paper/computer files. 
  
 RETRIEVABILITY: 
  
 During data collection stages and
follow-up, retrieval is by personal identifier (e.g., name, Social Security Number, medical record or study identification number, etc.). During the data analysis stage, data are normally retrieved by the variables of interest (e.g., diagnosis, age,
occupation). 
  
 SAFEGUARDS: 
  
 1. Authorized Users: Access to identifiers and to link files is strictly
limited to the authorized personnel whose duties require such 

  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 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. 
  
 [[Page 16599]] 
  
 Researchers authorized to conduct research on biologic specimens will typically access the system through the use of encrypted identifiers sufficient to
link individuals with records in such a manner that does not compromise confidentiality of the individual. 
  
 2. Physical Safeguards: Records are either stored in locked rooms during off-duty hours, locked file cabinets, and/or secured computer facilities. For
certain studies, personal identifiers and link files are separated and stored in locked files. Computer data access is limited through the use of key words known only to authorized personnel. 
  
 3. Procedural Safeguards: Collection and maintenance of data is consistent
with legislation and regulations in the protection of human subjects, informed consent, confidentiality, and confidentiality specific to drug and alcohol abuse patients where these apply. When anonymous data is provided to research scientists for
analysis, study numbers which can be matched to personal identifiers will be eliminated, scrambled, or replaced by the agency or contractor with random numbers which cannot be matched. Contractors who maintain records in this system are instructed
to make no further disclosure of the records. Privacy Act requirements are specifically included in contracts for survey and research activities related to this system. The OHS project directors, contract officers, and project officers oversee
compliance with these requirements. Personnel having access are trained in Privacy Act requirements. Depending upon the sensitivity of the information in the record, additional safeguard measures may be employed. 
  
 4. Implementation Guidelines: DHHS Chapter 45-13 and supplementary Chapter
PHS.hf: 45-13 of the HHS General Administration Manual and Part 6, “ADP System Security” of the HHS ADP Systems Security Manual. 
  
 RETENTION AND DISPOSAL: 
  
 Records are retained and disposed of under the authority of the NIH Records Control Schedule contained in NIH Manual Chapter 1743, Appendix
1—“Keeping and Destroying Records” (HHS Records Management Manual, Appendix B-361), item 3000-G-3, which allows records to be kept as long as they are useful in scientific research. Collaborative Perinatal Project records are retained
in accordance with item 3000-G-4, which does not allow records to be destroyed. William A. White Clinical Research Program medical records (Saint Elizabeths Hospital, NIMH) are retained for 5 years after last discharge or upon death of a patient and
then transferred to the Washington National Records Center, where they are retained until 30 years after discharge or death. Refer to the NIH Manual Chapter for specific conditions on disposal or retention instructions. 
  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 SYSTEM MANAGER(S) AND ADDRESS: 
  
 See Appendix I for a listing of current system managers. This system is for use by all NIH Institutes, Centers, and
Divisions. 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 Research Patient Records, HHS/NIH/NIDR
	09-25-0044	  	Clinical Research: Sensory Testing Research Program, HHS/NIH/NIDR
	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’s Lymphonma Registry, HHS/NIH/NCI
	09-25-0060	  	Clinical Research: Division of Cancer Treatment 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: Studies in the Division of Cancer Cause and Prevention, HHS/NIH/NCI

  

 Attachment 5 

 Contract No. HHSN261200655000C 
  

			
	09-25-0134	  	Clinical Research: Epidemiology Studies, National Institute of Environmental Health Sciences, HHS/NIH/NIEHS
	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 Research Contracted Epidemiological and Biometric Studies, HHS/NIH/NIDR
	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 Center for Human Genome Research, HHS/NIH/NCHGR
	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

  
 [[Page 16600]] 
  
 NOTIFICATION PROCEDURE: 
  
 To determine if a record exists, write to the appropriate ICD Privacy Act Coordinator listed below. In cases where the
requestor 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 requestor must verify his or her identity by providing either a notarization of the request or by submitting a written certification that
the requestor is 

  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 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, Center or Division 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, Building 31, Room 1B05, 31 Center Drive MSC 2075, Bethesda, MD 20892- 2075. 
  
 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 
  
 National Eye Institute (NEI) 
  
 Privacy Act Coordinator, NEI, NIH 
 Building 31, Room 6A-19 
 31 Center Drive 
 Bethesda, MD 20892 
  
 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 
  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 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 5QS49 
 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 Research (NIDR) 
  
 Privacy Act Coordinator, NIDR, NIH 
 Building
31, Room 2C-35 
 31 Center Drive, MSC 2290 
 Bethesda, MD 20892-2290 
  
 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, Maryland 20857 
  
 National Institute of Environmental Health Sciences (NIEHS) 
  
 Chief, Epidemiology Branch, NIEHS, NIH 
 P.O. Box 12233 
 Research Triangle Park 
 North Carolina 27709 
  
 National Institute of Mental Health (NIMH) 
  
 Privacy Act Coordinator, NIMH, NIH 
 Parklawn
Building, Room 7C-22 
 5600 Fishers Lane 
 Rockville, Maryland 20857 
  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 National Institute of Neurological Disorders and Stroke (NINDS) 
  
 Privacy Act Coordinator, NINDS, NIH 
 Federal Building, Room 816 
 7550 Wisconsin
Avenue 
 Bethesda, MD 20892 
  
 National Center for Human Genome Research (NCHGR) 
  
 Chief, Office of Human Genome Communications, NGHGR, NIH 
 Building 38A, Room 617 
 9000 Rockville Pike

 Bethesda, Maryland 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. 
  
 Appendix I: System Managers and Addresses 
  
 Office of the Director, NIH

  
 [[Page 16601]] 
  
 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 
  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 Executive Plaza North, Suite 434 
 6130 Executive Blvd. 
 Bethesda, MD 20892 
  
 Chief, Genetic Epidemiology Branch, EBP, DCE, NCI, NIH 
 Executive Plaza North, Suite 439 
 6130
Executive Blvd. 
 Bethesda, MD 20892 
  
 Chief, Clinical Genetics Section 
 Clinical
Epidemiology Branch, DCE, NCI, NIH 
 Executive Plaza North, Suite 400 
 6130 Executive Blvd. 
 Bethesda, MD 20892

  
 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, DCT, NCI, NIH 
 8601 Old Georgetown Road 
 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 
  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 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 
  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 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, Maryland 20892 
  
 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 400B 
 6120
Executive Boulevard 
 Rockville, MD 20852 
  
 National Institute of Dental Research 
  
 Deputy Clinical Director, NIDR, NIH 
 Building
10, Room 1N-113 
 10 Center Drive, MSC 1190 
 Bethesda, MD 20892-1190 
  
 Research Psychologist, Clinical Invsetigations, NIDR, NIH 
 Building 10, Room 1N114 
 10 Center Drive, MSC 1190 
 Bethesda, MD
20892-1190 
  
 Chief, Contract Management Section 
 Extramural Program, NIDR, NIH 
 Natcher
Building, Room 4AN-44B 
 45 Center Drive, MSC 6402 
 Bethesda, MD 20892-6402 
  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 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, Arizona 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, Maryland 20857 
  
 National Institute
of Environmental Health Sciences 
  
 Chief, Epidemiology Branch,
NIEHS, NIH 
 P.O. Box 12233 
 Research Triangle Park 
 North Carolina 27709 
  
 National Institute of Mental Health 
  
 Director, Intramural Research Program, NIMH, NIH 
 Building 10, Room 4N-224 
 9000 Rockville Pike 
 Bethesda, MD 20205 
  
 Privacy
Act Coordinator, NIMH, NIH 
 Parklawn Building, Room 7C22 
 5600 Fishers Lane 
 Rockville, Maryland 20857 
  
 Clinical Director, Neuroscience Research Center, DIRP, NIMH 
 Saint Elizabeths Hospital, 
 William A. White
Building, Room 133 
 2700 Martin Luther King Jr., Avenue, SE 
 Washington, DC 20032 
  
 National Institute of
Neurological Disorders and Stroke 
  
 [[Page 16602]] 
  
 Chief, Epilepsy Branch, NINDS, NIH 
 Federal Building, Room 114 
 7750 Wisconsin
Avenue 
 Bethesda, MD 20892 
  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 Chief, Development Neurology Branch, NINDS, NIH 
 Federal Building, NIH 
 7550 Wisconsin Avenue

 Bethesda, MD 20892 
  
 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 Neurosciences, NINDS, NIH 
 Federal Building, Room 916 
 7550 Wisconsin Ave 
 Bethesda, MD 20892 
  
 Director, Division of Convulsive, Developmental and Neuromuscular Disorders, NINDS, NIH 
 Federal Building, Room 816 
 7550 Wisconsin
Avenue 
 Bethesda, MD 20892 
  
 Director, Division of Demyelinating Atrophic, and Dementing Disorders, NINDS, NIH 
 Federal Building, Room 810 
 7550 Wisconsin
Avenue 
 Bethesda, MD 20892 
  
 Director, Division of Stroke and Trauma, NINDS, NIH 
 Federal Building, Room 8A08 
 7550 Wisconsin Avenue 
 Bethesda, MD 20892 
  
 National Center for Human
Genome Research 
  
 Chief, Office of Human Genome Communications,
NCHGR, NIH 
 Building 38A, Room 617 
 9000 Rockville Pike 
 Bethesda, MD 20892 
  

 Attachment 5 

 Contract No. HHSN261200655000C 
  
 HHSAR 352.223-70 SAFETY AND HEALTH (JANUARY 2001) 
  

	(a)	To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State and local laws and
regulations applicable to the work being performed under this contract. These laws are implemented and/or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration and other agencies at the Federal, State and
local levels (Federal, State and local regulatory/enforcement agencies). 

  

	(b)	Further, the Contractor shall take or cause to be taken additional safety measures as the Contracting Officer in conjunction with the project or other appropriate officer,
determines to be reasonably necessary. If compliance with these additional safety measures results in an increase or decrease in the cost or time required for performance of any part of work under this contract, an equitable adjustment will be made
in accordance with the applicable “Changes” Clause set forth in this contract. 

  

	(c)	The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic
substances, hazardous materials or hazardous operations; the injury or death of any person; and/or damage to property incidental to work performed under the contract and all violations for which the Contractor has been cited by any Federal,
State or local regulatory/enforcement agency. The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be
performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary
corrective action. 

  

	(d)	If the Contractor fails or refuses to comply promptly with the Federal, State or local regulatory/enforcement agency’s directive(s) regarding any violation(s) and prescribed
corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State or local regulatory/enforcement agencies) has been taken and documented to the
Contracting Officer. No part of the time lost due to any stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor. 

  

	(e)	The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or operations. Compliance with the provisions of this
clause by subcontractors will be the responsibility of the Contractor. 

  
 (End of clause) 
  

			
	Safety and Health Clause	 	ATTACHMENT 6
	HHSAR 352.223-70, (1/01)	 	 

 Contract No. HHSN261200655000C 
  
 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. 
  

			
	NIH(RC) -7 (4/1/84)	 	ATTACHMENT 7
	OMB Bulletin 81-16	 	 

 Contract No. HHSN261200655000C 
  
 GOVERNMENT PROPERTY – SCHEDULE 
  
 SCHEDULE I-B 
  

			
	 ITEM

	  	QUANTITY

	LN2 Freezer, XLC-1830	  	    10
	Freezer Racks	  	1080
	So-Low Mechanical Freezers C80-27 w/27 cubic ft capacity	  	    58
	Freezer Racks	  	    75
	UPS System for Gentra	  	      1
	Centrifuge	  	      1
	Rotor	  	      1
	5 x 50 Adapter	  	      1
	12 x 15 Adapter	  	      1

  

			
	Government Property Schedule -	 	ATTACHMENT 8
	(    /    /    )	 	Page 1

 Contract No. HHSN261200655000C 
  
 REPORT OF GOVERNMENT OWNED, CONTRACTOR HELD PROPERTY 
  

			
	CONTRACTOR:	  	CONTRACT NUMBER
	  	 
	  	 
	  	 
	ADDRESS	  	REPORT DATE:
	  	 
	  	 
	  	 
	  	 
	  	 
	  	FISCAL YEAR:
	  	 
	  	 
	  	 

  

															
	 CLASSIFICATION

	  	BEGINNING OF
PERIOD

	  	ADJUSTMENTS

	  	END OF PERIOD

	 	  	# ITEMS

	  	VALUE

	  	GFP
ADDED

	  	CAP
ADDED

	  	DELETIONS

	  	# ITEMS

	  	VALUE

								
	 LAND>=$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
								
	 LAND<$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
								
	 OTHER REAL>=$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
								
	 OTHER REAL<$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
								
	 PROPERTY UNDER CONST>=$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
								
	 PROPERTY UNDER CONST<$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
								
	 PLANT EQUIP>=$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
								
	 PLANT EQUIP<$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
								
	 SPECIAL TOOLING >=$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
								
	 SPECIAL TOOLING<$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
								
	 SPECIAL TEST EQUIP>=$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
								
	 SPECIAL TEST EQUIP<$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
								
	 AGENCY PECULIAR>=$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
								
	 AGENCY PECULIAR<$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
						
	 MATERIAL>=$25K (CUMULATIVE)
	  	 	  	 	  	 	  	 	  	 
								
	 PROPERTY UNDER MFR>=$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
								
	 PROPERTY UNDER MFR<$25K
	  	 	  	 	  	 	  	 	  	 	  	 	  	 
		
	SIGNED BY:	  	DATE SIGNED:
	  
	  

  

			
	Report of Government Owned, Contractor Held Property	 	ATTACHMENT 10

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