Exhibit 10.32
AWARD/CONTRACT | | 1. THIS CONTRACT IS A RATED ORDER UNDER DPAS (15 CFR 350) | | RATING |
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2. CONTRACT (Proc. Inst Ident.) NO. | | 3. EFFECTIVE DATE | 4. REQUISITION PURCHASE REQUEST/PROJECT NO. |
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N02-CP-11001 | | 06/01/2001 | | | |
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5. ISSUED BY | CODE | 261011001 | 6. ADMINISTERED BY (If other than item 5) | CODE |
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National Cancer Institute | OD | |
Research Contracts Branch, ESS | Office of Director | |
Executive Plaza South, Room 620 | Division of Epidemiology and Genetics | |
9000 Rockville Pike MSC 7224 | (RFP No. N02CP11001-66) | |
Bethesda Maryland 20892-7224 | | |
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7. NAME AND ADDRESS OF THE CONTRACTOR (No., street, city, county, State and ZIP Code) | | 8. DELIVERY |
| | | | | ý FOB Destination | o FOB Origin |
BBI Biotech Research Laboratories | | | | | |
217 Perry Parkway | | | | | 9. DISCOUNT FOR PROMPT PAYMENT |
Gaithersburg, Maryland 20877 |
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| | | | | 10. SUBMIT INVOICES | | ITEM |
| | | | | (a copies unless otherwise specified) | | |
PLACE OF PERFORMANCE: Frederick, Maryland | | | TO THE ADDRESS SHOWN IN | | SEE SECTION G |
CODE | | FACILITY CODE | | | u | | ARTICLE G. 4. |
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11. SHIP TO/MARK FOR | | CODE | 12. PAYMENT WILL BE MADE BY | CODE |
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SEE SECTION F, ARTICLE F.1. | | | SEE SECTION G, ARTICLE G.4. | |
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13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION | 14. ACCOUNTING AND APPROPRIATION DATA |
| | | CAN1 | | 18332860 | TIN | | 043152484 |
10.U.S.C. 2304(c) ( ) ?1 U.S.C. 253(c) ( ) | CAN2 | | | DOC NO. | | N2CP11001A |
| | | OC CODE | | 25.2E | LOC | | |
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15A. ITEM NO. | 15B SUPPLIES/SERVICES | 15C. QUANTITY | 15D. UNIT | 15E. UNIT PRICE | 15F. AMOUNT |
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TITLE: | Laboratory Support for Processing and Storage of Biological Specimens for Persons at High Risk of Cancer | CAN1: | $ | 1,500,000 |
| CAN2: | $ | |
CURRENT OBLIGATION: | | $ | 1,500,000 |
CONTRACT PERIOD: | | |
CONTRACT TYPE: | | | | | |
| 06/01/2001 through 05/31/2006 | | | $ |
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| Cost-Plus-Fixed Fee, COMPLETION, Work Assignments | $ |
| | 15G. TOTAL AMOUNT OF CONTRACT | $ | 10,326,558 |
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16. TABLE OF CONTENTS
(X) | | SEC. | | DESCRIPTION | |
| | | | PART I - THE SCHEDULE | |
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X | | A | | SOLICITATION/CONTRACT FORM | |
X | | B | | SUPPLIES OF SERVICES AND PRICES/COSTS | |
X | | C | | DESCRIPTION/SPECS/WORK STATEMENT | |
X | | D | | PACKAGING AND MARKING | |
X | | E | | INSPECTION AND ACCEPTANCE | |
X | | F | | DELIVERIES OR PERFORMANCE | |
X | | G | | CONTRACT ADMINISTRATION DATA | |
X | | H | | SPECIAL CONTRACT REQUIREMENTS | |
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| | | | PART II - CONTRACT CLAUSES | |
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X | | I | | CONTRACT CLAUSES | |
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| | | | PART III - LIST OF DOCMENTS, EXHIBITS AND OTHER ATTACH | |
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X | | J | | LIST OF ATTACHMENTS | |
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| | | | PART IV - REPRESENTATIONS AND INSTRUCTIONS | |
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X | | K | | REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS | |
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| | L | | INSTRS.. CONDS.. AND NOTICES TO OFFERORS | |
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| | M | | EVALUATION FOR AWARD | |
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
17. ý CONTRACTORS NEGOTIATED AGREEMENT (Contractor is required to sign this document 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. o AWARD (Contractor is not required to sign this document.) Your offer on Solicitation Number including the additions 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. |
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19A. NAME AND TITLE OF SIGNER (Type or print) | | 20A. NAME OF CONTRACTING OFFICER |
Mark Manak, General Manager | | SHARON A. MILLER |
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19B. NAME OF CONTRACTOR | 19C. DATE SIGNED | | 20B. UNITED STATES OF AMERICA | 20C. DATE SIGNED |
BY | /s/ Mark Manak | | May 8, 2001 | | BY | /s/ Sharon A. Miller | | 6-1-01 |
| (Signature of person authorized to sign) | | | | | (Signature of Contracting officer) | | |
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NSN [ILLEGIBLE] | 26-107 | STANDARD FORM 26 (REV 4-85) |
PREVIOUS EDITION UNUSABLE | •GPO [ILLEGIBLE] | Prescribed by GSA |
| | [ILLEGIBLE] |
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DETAILED TABLE OF CONTRACT CONTENTS
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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 blorepository 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 $9,811,557.
b. The fixed fee for this contract is $515,001. 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 $10,326,558.
d. Total funds currently available for payment and allotted to this contract are $1,500,000 of which $1,426,262 represents the estimated costs, and of which $73,738 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 February 28, 2002.
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 less, of any interest in real property;
(2) Special rearrangement or alteration of facilities;
(3) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than
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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 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 $4,885 without the prior written approval of the Contracting Officer.
(b) The Contractor shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulations (FAR) 31.205-46.
(2) Foreign Travel
Requests for foreign travel must be submitted at least six weeks in advance and shall contain the following: (a) meeting(s) and place(s) to be visited, with costs and dates; (b) name(s) and title(s) of Contractor personnel to travel and their functions in the contract project; (c) contract purposes to be served by the travel; (d) how travel of contractor personnel will benefit and contribute to accomplishing the contract project, or will otherwise justify the expenditure of NIH contract funds; (e) how such advantages justify the costs for travel and absence from the project of more than one person if such are suggested; and (f) what additional functions may be performed by the travelers to accomplish other purposes of the contract and thus further benefit the project.
ARTICLE B.4. ADVANCE UNDERSTANDINGS
Other provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting Officer.
a. Total expenditures for moving freezers to 5107 Pegasus Court, Frederick, MD from 217 Perry Parkway, Gaithersburg, MD incurred in direct performance of this contract shall not exceed $83,040 without prior written approval of the Contracting Officer.
b. The government’s obligation under this contract is the total dollars authorized by the work assignments issued under the contract.
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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1. STATEMENT OF WORK
a. Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work, SECTION J, ATTACHMENT I, dated August 2000, attached hereto and made a part of this contract.
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 and Written Reports summarizing the status of all newly received specimens and outlining all dispersals by the laboratory. The information should by tracked by project code and submitted with the quarterly report. A summary of all correspondence consisting of requests for shipment, cover letters and inquiries from outside collaborators shall be submitted quarterly to the NCI Project Officer 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 September 15, 2001. Thereafter, reports shall be due on or before the 15th day of the month following each quarterly reporting period. A Quarterly Computerized and Written Report shall not be required when submitting the Annual Reports or Final Report.
(2) Annual Technical Progress Report
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, nothing 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;
c) An indication of current problems that may impede performance under the contract and proposed corrective action; and
e) A summary of work assignments issued to date, general progress on each work assignment, and the estimated and actual cost to date on each assignment.
d) A discussion of work to be performed during the next reporting period.
The annual report shall, in addition, include the information described in item #9 of the statement of work. 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
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the contract and shall be due on or before July 1, 2002. 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 period of performance.
SECTION D - PACKAGING, MARKING AND SHIPPING
ARTICLE D.1. PACKAGING
Specimens shall be protected from temperature extremes by use of insulated containers or other acceptable means as needed. Portable liquid nitrogen containers for transport of frozen cells shall also be required.
All deliverable under this contract shall be clearly identified with the subject contract number. All specimens shall be submitted to the Contractor, accompanied by written identification of the specimen source, using forms supplied by the Project Officer. All specimens will be submitted to the Contractor with a unique alpha-numeric code number which will be the only identification of the specimen in future laboratory processing, dispersal, etc. The name of the donor shall not be used in the labeling of specimens by laboratory personnel. No names of persons enrolled in AIDS-associated studies shall be written on vials.
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. For immunologic or genetic typing studies, for example, the Contractor shall prepare specimens for delivery to the local Human Leukocyte Antigen (HLA) typing laboratory or immune function laboratory in a suitable form. 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 for 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.
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
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representative within 60 days of receipt.
d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.
FAR Clause No. 52.246-5, INSPECTION OF SERVICES-COST REIMBURSEMENT (APRIL 1984).
SECTION F - DELIVERIES OR PERFORMANCE
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 ser forth in FAR 52.247-35, F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the dates specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of the contract:
Item | | Description | | Quantity | | Delivery Schedule |
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(1) | | Quarterly Computerized and Written Reports | | 3 | | First report due 09/15/01; all others due on the 15th day of the month following each Quarterly reporting period. |
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(2) | | Annual Technical Progress Report | | 3 | | July 1, 2002
July 1, 2003
July 1, 2004
July 1, 2005 |
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(3) | | Final Technical Progress Report | | 3 | | On or before May 31, 2006 |
b. The above items (1) through (3) shall be addressed and delivered to:
Original: | | Contracting Officer |
| | Epidemiology and Support Section |
| | Research Contract Branch, OD |
| | National Cancer Institute |
| | Executive Plaza South, Room 620 |
| | 6120 EXECUTIVE BLVD MSC 7224 |
| | BETHESDA, MD 20892-7224 |
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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 |
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ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)
This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.arnet.gov/far/.
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
52.242-15. Stop Work Order (AUGUST 1989) with ALTERNATE (APRIL 1984).
The following Project Officer and Assistant Officers will represent the Government for the purpose of this contract:
Dr. Jim Vaught, Project Officer |
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Assistant Project Officers: | | Dr. Dalsu Baris |
| | Dr. Mark Green |
| | Dr. Rashmi Sinha |
| | Dr. Mark Schiffman |
| | Dr. Charles Rabkin |
| | Dr. Neil Caporaso |
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 Officer’s 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.
Pursuant to the Key Personnel clause incorporated in this contract, the following individuals are considered to be essential to the work being performed hereunder:
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Name | | Title |
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Mark Cosentino | | Principal Investigator |
Jay Ji | | Assistant Investigator |
Andy Slywester | | Assistant Investigator |
Kathi Shea | | Assistant Investigator |
Caria Hanson | | Project 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, 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 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 specific, finite task.
(3) Each new W.A. shall be numbered serially beginning with 01.
(4) Each W.A. shall be completed on 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 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.
(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.
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(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, 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.
(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)-I 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:
An original and two copies to the following designed billing office:
Contracting Officer
Research Contracts Branch
National Cancer Institute, NIH
EPS, Room 620
6120 EXECUTIVE BLVD MSC 7224
BETHESDA MD 20892-7224
(2) Inquiries regarding payment of invoices should be directed to the designed billing office, (301)496-8611.
(3) Inquiries regarding actual payment of invoices should be direct to the designed payment office, (301)496-6452.
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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.
c. Fee billed under this contract shall be based upon total costs excluding equipment costs.
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 costs (expenditure categories) which shall be reported within the total contract are discussed in paragraphe., below. Subsequent changes and/or additions in the line entries shall be made in writing.
b. Unless otherwise started 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 reports 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 4, 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
Officer of Contracts Management
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.
ARTICLES G.7. GOVERNMENT PROPERTY
a. In additional 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.
This contract’s Contracts Property Administrator is:
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Contracts Property Administrator
Division of Personal Property Services, NIH
6011 Building, Suite 637
6011 EXECUTIVE BLVE MSC 7670
BETHESDA MD 20852-7670
(301) 496-6466
b. Notwithstanding the provisions outlined in the DHHS Publication. Contractor’s Guide for Control of Government Property, 1990 which is incorporated in this contract in paragraph a. above, the contractor shall use the form entitled, “Report of Government Owned, Contractor Held Property” for performing annual inventories required under this contract. This form is included as an attachment in SECTION J of this contract.
c. Contractor-Acquired Under Government Property - Schedule I-B
Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this contract, the Contractor will be authorized to acquire the property listed in the attached Schedule I-B for use in direct performance of the contract, following receipt of the Contracting Officers 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 Contract is hereby authorized to retain custody of all Government Property acquired or furnished under predecessor Contract No. N02-CP-71001 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 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. Any disagreement between the parties regarding an evaluation will be referred to an individual one level above the Contracting Officer, whose decision will be final.
Copies of the evaluations, contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.
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
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be authorized access to the evaluation for review and comment. In addition, the contractor will be required to identify an alternate contact who will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.
SECTION H - SPECIAL CONTRACT REQUIREMENTS
ARTICLES H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT PROJECTS
The primary purpose of the Public Health Service (PHS) is to support and advance independent research within the scientific community. This support is provided in the form of contracts and grants totaling approximately 7 billion dollars annually. PHS has established effective, time tested and well recognized procedures for stimulating and supporting this independent research by selecting from multitudes of applications those research projects most worthy of support within the constraints of its appropriations. The reimbursement through the indirect cost mechanism of independent research and development costs not incidental to product improvement would circumvent this competitive process.
To ensure that all research and development projects receive similar and equal consideration, all organizations may compete for direct funding of independent research and development projects they consider worthy of support by submitting those projects to the appropriate Public Health Service grant office for review. Since these projects may be submitted for direct funding, the Contractor agrees that no costs for any independent research and development project, including all applicable indirect costs, will be claimed under this contract.
ARTICLE H.2. HUMAN SUBJECTS
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 Contactor for use by anyone other that the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.
ARTICLE H.3. HUMAN MATERIALS
It is understood that the acquisition and supply of all human specimen material (including fetal material) used under this contract will be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States and that no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.
ARTICLE H.4. NEEDLE EXCHANGE
a. | | Pursuant to Public Law(s) citied 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. 106-554, Section 505 | | 2001 | | (10/1/00 - 9/30/01) |
ARTICLE H.5. PRIVACY ACT
This procurement action requires the Contractor to do one more of the following; design, develop, or operate a system of
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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 penaltics.
The Privacy Act System of Records applicable to this projects is Number 09-25-0200. This document is incorporated into this contract as Attachment 6.
ARTICLE H.6. CONFIDENTIALITY OF INFORMATION
The following information is covered by HHSAR Clause 352.224-70, Confidentiality of Information (APRIL 1984):
• Identification of Specimen source or donor name;
• All records of manipulations on all sepecimens;
• Information concerning the identification of the patient, the diagnosis, demographic information or other such information;
• Written, hard-copy records of inventory sheets.
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 acknowledgement 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, under Contractor No. N02-CP-11001.”
ARTICLES 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 projects 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. 106-554, Section 505 | | 2001 | | (10/1/00-9/30/01) |
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
Information regarding procedural matters is contained in the NIH Manual Chapter 1754, which is available on (http://www3.od.nih.gov/oma/mantial/chapters/management/1754/)
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PART II - CONTRACT CLAUSES
SECTION I - - CONTRACT CLAUSES
ARTICLE 1.1. 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 | | Oct 1995 | | Definitions |
| | | | |
52.203-3 | | Apr 1984 | | Gratuities (Over $100,000) |
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52.203-5 | | Apr 1984 | | Covenant Against Contingent Fees (Over $100,000) |
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52.203-6 | | Jul 1995 | | Restrictions on Subcontractor Sales to the Government (Over $100,000) |
| | | | |
52.203-7 | | Jul 1995 | | Anti-Kickback Procedures(Over $100,000) |
| | | | |
52.203-8 | | Jan 1997 | | Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over $100,000) |
| | | | |
52.203-10 | | Jan 1997 | | Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000) |
| | | | |
52.203-12 | | Jun 1997 | | Limitation on Payments to Influence Certain Federal Transactions (Over $100,000) |
| | | | |
52.204-4 | | Aug 2000 | | Printed or Copied Double-Sided on Recycled Paper (Over $100,000) |
| | | | |
52.209-6 | | Jul 1995 | | Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $25,000) |
| | | | |
52.215-2 | | Jun 1999 | | Audit and Records - Negotiation (Over $100,000) |
| | | | |
52.215-8 | | Oct 1997 | | Order of Precedence - Uniform Contract Format |
| | | | |
52.215-10 | | Oct 1997 | | Price Reduction for Defective Cost or Pricing Data |
| | | | |
52.215-12 | | Oct 1997 | | Subcontractor Cost or Pricing Data (Over $500,000) |
| | | | |
52.215-14 | | Oct 1997 | | Integrity of Unit Prices (Over $100,000) |
| | | | |
52.215-15 | | Dec 1998 | | Pension Adjustments and Asset Reversions |
| | | | |
52.215-18 | | Oct 1997 | | Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions |
| | | | |
52.215-19 | | Oct 1997 | | Notification of Ownership Changes |
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52.215-21 | | Oct 1997 | | Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data - Modifications |
| | | | |
52.216-7 | | Mar 2000 | | Allowable Cost and Payment |
| | | | |
52.216-8 | | Mar 1997 | | Fixed Fee |
| | | | |
52.219-8 | | Oct 2000 | | Utilization of Small Business Concerns (Over $100,000) |
| | | | |
52.219-9 | | Oct 2000 | | Small Business Subcontracting Plan (Over $500,000) |
| | | | |
52.219-16 | | Jan 1999 | | Liquidated Damages - Subcontracting Plan (Over $500,000) |
| | | | |
52.222-2 | | Jul 1990 | | Payment for Overtime Premium (Over $100,000) (Note: The dollar amount in paragraph (a) of this clause is $0 unless otherwise specified in the contract.) |
| | | | |
52.222-3 | | Aug 1996 | | Convict Labor |
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52.222-26 | | Feb 1999 | | Equal Opportunity |
| | | | |
52.222-35 | | Apr 1998 | | Affirmative Action for Disabled Veterans and Veterans of the Vietnam Era |
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52.222-36 | | Jun 1998 | | Affirmative Action for Workers with Disabilities |
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52.222-37 | | Jan 1999 | | Employment Reports on Disabled Veterans and Veterans of the Vietnam Era |
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52.223-6 | | Jan 1997 | | Drug-Free Workplace |
| | | | |
52.223-14 | | Oct 2000 | | Toxic Chemical Release Reporting |
| | | | |
52.225-1 | | Feb 2000 | | Buy American Act - Balance of Payments Program - Supplies |
| | | | |
52.225-13 | | Jul 2000 | | 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 |
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52.232-9 | | Apr 1984 | | Limitation on Withholding of Payments |
| | | | |
52.232-17 | | Jun 1996 | | Interest (Over $100,000) |
| | | | |
52.232-20 | | Apr 1984 | | Limitation of Cost |
| | | | |
52.232-23 | | Jan 1986 | | Assignment of Claims |
| | | | |
52.232-25 | | Jun 1997 | | Prompt Payment |
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52.232-34 | | May 1999 | | Payment by Electronic Funds Transfer—Other Than Central Contractor Registration |
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52.233-1 | | Dec 1998 | | Disputes |
| | | | |
52.233-3 | | Aug 1996 | | Protest After Award, Alternate I (Jun 1985) |
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52.242-1 | | Apr 1984 | | Notice of Intent to Disallow Costs |
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52.242-3 | | Oct 1995 | | Penalties for Unallowable Costs (Over $500,000) |
| | | | |
52.242-4 | | Jan 1997 | | Certification of Final Indirect Costs |
| | | | |
52.242-13 | | Jul 1995 | | Bankruptcy (Over $100,000) |
| | | | |
52.243-2 | | Aug 1987 | | Changes - Cost Reimbursement, Alternate I (Apr 1984) |
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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. |
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52.244-5 | | Dec 1996 | | Competition in Subcontracting (Over $100,000) |
| | | | |
52.245-5 | | Jan 1986 | | Government Property (Cost-Reimbursement, Time and Material, or Labor-Hour Contract) |
| | | | |
52.246-25 | | 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) |
| | | | |
352.228-7 | | Dec 1991 | | Insurance - Liability to Third Persons |
| | | | |
352.232-9 | | Apr 1984 | | Withholding of Contract Payments |
| | | | |
352.233-70 | | Apr 1984 | | Litigation and Claims |
| | | | |
352.242-71 | | Apr 1984 | | Final Decisions on Audit Findings |
| | | | |
352.270-5 | | Apr 1984 | | Key Personnel |
| | | | |
352.270-6 | | Jul 1991 | | Publications and Publicity |
| | | | |
352.270-7 | | Jan 2001 | | Paperwork Reduction Act |
[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT SERVICE CONTRACT - Rev. 2/2001].
ARTICLE 1.2 AUTHORIZED SUBSTITUTION OF CLAUSES
ARTICLE 1.1. of this SECTION is hereby modified as follows:
FAR Clause 52.219-9, SMALL BUSINESS SUBCONTRACTING PLAN (OCTOBER 2000), and FAR Clause 52.219-16, LIQUIDATED DAMAGES—SUBCONTRACTING PLAN (JANUARY 1999) are deleted in their entirety.
FAR Clause 52.232-20, LIMITATION OF COST, is deleted in its entirety and FAR Clause 52.232-22, LIMITATION OF
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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 1.3. 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 ?) CLAUSES
(1) | FAR 52.215-17, Waiver of Facilities Capital Cost of Money (OCTOBER 1997). |
| |
(2) | FAR 52.219-6, Notice of Total Small Business Set-Aside (JULY 1996). |
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(3) | FAR 52.219-14, Limitations on Subcontracting (DECEMBER 1996). |
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(4) | FAR 52.224-1, Privacy Act Notification (APRIL 1984). |
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(5) | FAR 52.224-2, Privacy Act (APRIL 1984). |
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(6) | FAR 52.227-14, Rights in Data - General (JUNE 1987). |
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(7) | FAR 52.247-63, Preference for U.S. Flag Air Carriers (JANUARY 1997). |
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(8) | FAR 52.251-1, Government Supply Sources (APRIL 1984). |
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION/PUBLIC HEALTH SERVICE ACQUISITION REGULATION (HHSAR)/(PHSAR) (48 CHAPTER 3) CLAUSES:
(1) | HHSAR 352.223-70, Safety and Health (JANUARY 2001). |
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(2) | HHSAR 352.224-70, Confidentiality of Information (APRIL 1984). |
c. NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:
The following clauses are attached and made a part of this contract:
(1) | NIH (RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB Bulletin 81-16). |
ARTICLE 1.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
This contract incorporates the following clauses in full text.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
a. FAR Clause 52.244-6, SUBCONTRACTS FOR COMMERCIAL ITEMS AND COMMERCIAL COMPONENTS (OCTOBER 1998)
(a) Definition.
Commercial item, as used in this clause, has the meaning contained in the clause at 52.202-1, Definitions.
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Subcontract, as used in this clause, includes a transfer of commercial items between divisions, subsidiaries, or affiliates of the Contractor or subcontractor at any tier.
(b) To the maximum extent practicable, the Contractor shall incorporate, and require its subcontractors at all tiers to incorporate, commercial items or nondevelopmental items as components of items to be supplied under this contract.
(c) Notwithstanding any other clause of this contract, the Contractor is not required to include any FAR provision or clause, other than those listed below to the extent they are applicable and as may be required to establish the reasonableness of prices under Part 15, in a subcontract at any tier for commercial items or commercial components:
(1) 52.222-26, Equal Opportunity (E.O. 11246);
(2) 52.222-35, Affirmative Action for Disabled Veterans and Veterans of the Vietnam Era (38 U.S.C. 4212(a));
(3) 52.222-36, Affirmative Action for Workers with Disabilities (29 U.S.C. 793); and
(4) 52.247-64, Preference for Privately Owned U.S.-Flagged Commercial Vessels (46 U.S.C. 1241) (flow down not required for subcontracts awarded beginning May 1, 1996).
(d) The Contractor shall include the terms of this clause, including this paragraph (d), in subcontracts awarded under this contract.
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PART III
SECTION J - - LIST OF ATTACHMENTS
The following documents are attached and incorporated in this contract:
1. Statement of Work, August 2000, 5 pages.
2. Sample Contract Work Assignment, 4/95, 3 pages.
3. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-1 (5/97), 4 pages.
4. Financial Report of Individual Project/Contract, NIH 2706, (5/97), 1 page.
5. Instructions for Completing form NIH 2706, Financial Report of Individual Project/Contract, (5/97), 3 pages.
6. 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.
7. Safety and Health, HHSAR Clause 352.223-70, (1/01), 1 page.
8. Procurement of Certain Equipment, NIH(RC)-7, 4/1/84, 1 page.
9. Government Property - Schedule I-B.
10. Government Property - Schedule II-A.
11. Report of Government Owned, Contractor Held Property, 1 page.
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PART IV
SECTION K - - REPRESENTATIONS AND CERTIFICATIONS
The following documents are incorporated by reference in this contract:
1. Representations and Certifications, dated November 14, 2000.
END of the SCHEDULE
(CONTRACT)
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STATEMENT OF WORK
ARTICLE C.1. STATEMENT OF WORK
a. 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;
c) Cryopreservation of bone marrow samples;
d) Storage of tumor extracts;
NOTE: Tumor extracts are not synonymous with the preparation of tumor antigens. Specific protocols will be provided by the NCI for extract preparations.
e) 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.
f) Cryopreservation of intact red blood cells;
g) Viable cryopreservation of previously established lymphoblastoid cell lines;
h) Storage of DNA and other biological materials as specified by the Project Officer (e.g., pathology slides and tissue block);
i) Extraction of DNA from biologic materials;
j) Specimen processing as required by NCI to preserve special biologic materials;
k) 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.
NOTE: In one “typical” day, the most labor-intensive procedure would be the processing of whole blood for cryopreservation of leukocytes. As many as 30 samples of approximately 30 ml each could be received.
l) Maintenance of the previously-established repository currently containing more than 2.0 million biological specimens and allowance for an estimated increase of up to 100% of freezer storage space.
Statement of Work | | ATTACHMENT 1 |
(August 2000) | | |
1
m) 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 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 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 a logbook 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 telephone. An after-hours telephone number of the Contractor’s 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 an alternate 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, using forms supplied by the Project Officer, 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 numbers shall comply with the format and convention established by the NCI Project Officer. 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.
6) The Contractor shall provide and train primary and backup staff in the operation of a computerized record
2
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, data received, specimen vial quality, etc. Data shall be entered into the system, with attention to extreme 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 floppy disks, which will be transmitted with the samples. The Contractor shall also use this system to monitor and track all activities related to specimens. The Project Officer will supply computer support for generating management reports for the contractor on a regular basis.
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 of 0.5 ml, plasma separation and storage, tumor tissue freezing, tumor tissue extracts, urine, serum, or blood fluid lyophilization, freezing and/or extraction 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 specimen 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 equipped with a stylus recording system indicating consistency of temperature, which shall be reviewed on a scheduled basis each day at specified time. 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 these particular freezers shall be hooked up 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 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 kept in a master log that is easy to understand. Information shall be supplied routinely to the NCI Project Officer on forms designed and supplied by NCI in conjunction with laboratory personnel. These records shall include number of vials, exact location of vials and specimen type. The Contractor shall conduct an inventory totaling 20 percent of all stored specimens on an annual basis and include the results in the Annual Report. The annual inventory shall be conducted in a manner that results in a complete inventory of all stored specimens over the course of the contract. 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 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). A copy of this written request and Contractor-generated correspondence shall be sent to the NCI Project Officer. All written requests for specimen distribution shall be acted upon within four working days of receipt, unless permission to delay such action is obtained from the Project Officer.
The Contractor shall not supply the outside collaborator with any information concerning the biological specimens other than code number, specimen type or other information essential to specimen processing.
3
Requests for identification of the patient, the diagnosis, demographic data or other such information shall be referred to the NCI Project Officer.
The Contraction 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. For immunologic or genetic typing studies, for example, the Contractor shall prepare specimens for delivery to the local HLA typing laboratory or immune function laboratory in a suitable form. 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. All specimens for both immunologic testing and HLA typing and serum or other type storage shall be processed by the Contractor. 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) A large repository of sera and cells used for immunogenetic tissue typing shall be inventoried, stored and maintained under this contract. This shall include preparing appropriate inventory forms for specimen storage, retrieval and shipment.
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.
13) The Contractor shall be prepared to process the following quantities of materials:
Material | | Max Daily
(vials) | | Typical Total Monthly Volume
(Individual Sample vials) | |
WBC Cryopreservation | | 60 | | 250 | |
Plasma/serum aliquoting | | 60 | | 250 | |
RBC cryopreservation | | 25 | | 750 | |
Pelleted lymphocytes | | 15 | | 600 | |
Buffy coat preps | | 20 | | 300 | |
Receipt frozen vials | | 10,000 | | 17,000 | |
Thawing/ aliquotting | | N/A | | 500 | |
Dispersal of specimens | | N/A | | 10,000 | |
DNA purification | | N/A | | 400 | |
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.
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For this aspect of the contract, it is anticipated that technicians shall be available at least one day per weekend through the entire period of this contract (the weekend blood samples will be less than 200 ml and from less than five donors).
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 provide a separate shipping/customs agent to coordinate shipping, clear specimens through customs at U.S. entry port, transfer to appropriate courier/express delivery service for shipment within the U.S., and notify 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. Delays of just one or two days will seriously jeopardize months of scientific and medical work. 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, with input from the Project Officer, shall develop methods and procedures that improve the quality and efficiency of current biologic specimen collection, 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 method to preserve RNA, especially mRNA.
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CONTRACT WORK ASSIGNMENT (W.A.)
Contractor: | BBI - Biotech Research Laboratories | W.A. Title: |
| Dr. Mark Cosentino | |
| 5107 Pegasus Court | |
| Frederick, MD 21704 | |
| | |
Contract No: N02-CP-11001 | |
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 2 |
April, 1995 | | |
1
CONTRACT WORK ASSIGNMENT (W.A.)
Contractor: | BBI - Biotech Research Laboratories | Contract No: N02-CP-11001 |
| Dr. Mark Cosentino | |
| 5107 Pegasus Court | |
| Frederick, MD 21704 | |
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
10. Fee
11. Equipment
12. Total Estimated Cost and Fee
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 W.A. amount, or change the W.A. leader without the prior written approval of the Project Officer and the Contracting Officer.
1. | For the Contractor: | | | Date: | | |
| (Signature) | | | | |
| | | | | |
| Typed name: | | | | | |
| | | | | |
| | | | | |
2. | For the Government: | | | Date: | | |
| (Project Officer) | | | | |
| | | | | |
| | | | Date: | | |
| (Contracting Officer) | | | | |
| | | | | | | | |
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CONTRACT WORK ASSIGNMENT (W.A.)
Contractor: | BBI - Biotech Research Laboratories | Contract No: N02-CP-11001 |
| Dr. Mark Cosentino | |
| 5107 Pegasus Court | |
| Frederick, MD 21704 | |
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.
10. Fee
11. Equipment
12. Total Estimated Cost and Fee
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.
1. | For the Contractor: | | | Date: | | |
| (Signature) | | | | |
| | | | | |
| Typed name: | | | | | |
| | | | | |
| | | | | |
2. | For the Government: | | | Date: | | |
| (Project Officer) | | | | |
| | | | | |
| | | | Date: | | |
| (Contracting Officer) | | | | |
| | | | | | | | |
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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 of self-designed form provided that it contains the information shown on the sample invoice/financing request.
Number of Copies: As indicated in the Invoice Submission Clause in the contract.
Frequency: Invoices/financing requests submitted in accordance with the Payment Clause shall be submitted monthly unless otherwise authorized by the contracting officer.
Cost Incurrence Period: Costs incurred must be within the contract performance period or covered by precontract cost provisions.
Billing of Costs Incurred: If billed costs include: (1) costs of a prior billing period, but not previously billed; or (2) costs incurred during the contract period and claimed after the contract period has expired, the amount and month(s) in which such costs were incurred shall be cited.
Contractor’s Fiscal Year: Invoices/financing requests shall be prepared in such a manner that costs claimed can be identified with the contractor’s fiscal year.
Currency: All NIH contracts are expressed in United States dollars. When payments are made in a currency other than United States dollars, billings on the contract shall be expressed, and payment by the United States Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the contractor. Notwithstanding the above, the total of all invoices paid under this contract may not exceed the United States dollars authorized.
Costs Requiring Prior Approval: Costs requiring the contracting officer’s approval, which are not set forth in an Advance Understanding in the contract shall be so identified and reference the Contracting Officer’s Authorization (COA) Number. In addition, any cost set forth in an Advance Understanding shall be shown as a separate line item on the request.
Invoice/Financing Request Identification: Each invoice/financing request shall be identified as either:
(a) Interim Invoice/Contract Financing Request — 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).
NIH(RC)-1 | | | | ATTACHMENT 3 |
Rev. 5/97 | | | | |
1
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 and Date — Insert the contract number and the effective date of the contract.
(e) Payee’s Name and Address — Show the contractor’s name (as it appears in the contract), correct address, and the title and phone number of the responsible official to whom payment is to be sent. When an approved assignment has been made by the contractor, or a different payee has been designated, then insert the name and address of the payee instead of the contractor.
(f) Total Estimated Cost of Contract — Insert the total estimated cost of the contract, exclusive of fixed-fee. For incrementally funded contracts, enter the amount currently obligated and available for payment.
(g) Total Fixed-Fee — Insert the total fixed-fee (where applicable). For incrementally funded contracts, enter the amount currently obligated and available for payment.
(h) Billing Period — Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.
(i) Amount Billed for Current Period — Insert the amount billed for the major cost elements, adjustments, and adjusted amounts for the period.
(j) Cumulative Amount from Inception — Insert the cumulative amounts billed for the major cost elements and adjusted amounts claimed during this contract.
(k) Direct Costs — Insert the major cost elements. For each element, consider the application of the paragraph entitled “Costs Requiring Prior Approval” on page 1 of these instructions.
(1) Direct Labor — Include salaries and wages paid (or accrued) for direct performance of the contract.
(2) Fringe Benefits — List any fringe benefits applicable to direct labor and billed as a direct cost. Fringe benefits included in indirect costs should not be identified here.
(3) Accountable Personal Property — Include permanent research equipment and general purpose equipment having a unit acquisition cost of $1,000 or more and having an expected service life of more than two years, and sensitive property regardless of cost (see the DHIIS Contractor’s Guide for Control of Government Property). Show permanent research equipment separate from general purpose equipment. Prepare and attach Form HHS-565, “Report of Accountable Property,” in accordance with the following instructions:
List each item for which reimbursement is requested. A reference shall be made to the following (as applicable):
• The item number for the specific piece of equipment listed in the Property Schedule.
2
• The COA letter and number, if the equipment is not covered by the Property Schedule.
• Be preceded by an asterisk (*) if the equipment is below the approval level.
Further itemization of invoices/financing requests shall only be required for items having specific limitations set forth in the contract.
(4) Materials and Supplies — Include equipment with unit costs of less than $1,000 or an expected service life of two years or less, and consumable material and supplies regardless of amount.
(5) Premium Pay — List remuneration in excess of the basic hourly rate.
(6) Consultant Fee — List fees paid to consultants. Identify consultant by name or category as set forth in the contract’s advance understanding or in the COA letter, as well as the effort (i.e., number of hours, days, etc.) and rate being billed.
(7) Travel — Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its territories and possessions. However, for an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel.
(8) Subcontract Costs — List subcontractor(s) by name and amount billed.
(9) Other — List all other direct costs in total unless exceeding $1,000 in amount. If over $1,000, list cost elements and dollar amounts separately. If the contract contains restrictions on any cost element, that cost element must be listed separately.
(l) Cost of Money (COM) — Cite the COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed.
(m) Indirect Costs—Overhead — Identify the cost base, indirect cost rate, and amount billed for each indirect cost category.
(n) Fixed-Fee Earned — Cite the formula or method of computation for the fixed-fee (if any). The fixed-fee must be claimed as provided for by the contract.
(o) Total Amounts Claimed — Insert the total amounts claimed for the current and cumulative periods.
(p) Adjustments — Include amounts conceded by the contractor, outstanding suspensions, and/or disapprovals subject to appeal.
(q) Grand Totals
The contracting officer may require the contractor to submit detailed support for costs claimed on one or more interim invoices/financing requests.
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SAMPLE INVOICE/FINANCING REQUEST
(a) | | Billing Office Name and Address | | (b) | | Invoice/Financing Request No. |
| | | | | | |
| | NATIONAL INSTITUTES OF HEALTH | | |
| | National Cancer Institute, RCB | | |
| | EPS, Room | | (c) | | Date Invoice Prepared |
| | 6120 EXECUTIVE BLVD MSC | | | | |
| | Bethesda, MD 20892- | | |
| | | | |
(e) | | Payee’s Name and Address | | (d) | | Contract No. and Effective Date |
| | | | | | |
| | ABC CORPORATION | | |
| | 100 Main Street | | | | |
| | Anywhere, U.S.A. zip code | | (f) | | Total Estimated Cost of Contract |
| | | | | | |
| | | | |
Attention: | | Name, Title, and Phone Number | | |
| | of Official to Whom Payment is Sent | | (g) | | Total Fixed Fee |
| | | | |
| | | | |
| | | | |
(h) | | This invoice/financing request represents reimbursable costs from Aug. 1, 1982 through Aug. 31, 1982 |
| | | | | | | | | | | |
| | (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 | |
| | | | | | | |
(j) | | Cost of Money (Factor) of (Approximate 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) |
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National Institutes of Health | | Project Task | | Contract No. | | Date of Report |
FINANCIAL REPORT OF INDIVIDUAL
PROJECT/CONTRACT, NIH FORM 2706 | | Laboratory Support for Processing and Storage of Biomedical Specimens of Persons | | N02-CP-11001
Contractor’s Name and Address | | | | 0990-0134
0990-0131 |
Note: Complete this form in accordance with
Accompanying Instructions. | | Reporting Period | | 5107 Pegasus | | | | |
| | | | Frederick, MD 21704 | | | | |
| | | | Cumulative
Incurred
Cost at End
of Prior
Period | | Incurred
Cost-Curent
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) | |
Expenditure Category | | | | | | | | | | | | |
| | |
Percentage of Effort/Hours |
Negotiated | | Actual |
A | | B | | C | | D | | E | | F | | G | | H | | I | | J | |
Direct Labor | | 139,205 | | | | | | | | | | | | | | $ | 2,560,213 | | | |
Materials & Supplies | | | | | | | | | | | | | | | | 1,420,490 | | | |
Travel | | | | | | | | | | | | | | | | 4,885 | | | |
Equipment | | | | | | | | | | | | | | | | 1,228,197 | | | |
Moving expenses | | | | | | | | | | | | | | | | 83,040 | | | |
Other Direct Costs | | | | | | | | | | | | | | | | 339,762 | | | |
Total Direct Costs: | | | | | | | | | | | | | | | | $ | 5,636,587 | | | |
Overhead | | | | | | | | | | | | | | | | 3,533,094 | | | |
?A | | | | | | | | | | | | | | | | 641,876 | | | |
Total Proposed Cost: | | | | | | | | | | | | | | | | $ | 9,811,558 | | | |
[ILLEGIBLE] Fee | | | | | | | | | | | | | | | | 515,001 | | | |
Total CPFF | | | | | | | | | | | | | | | | $ | 10,326,558 | | | |
| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | |
5
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 use 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 elements(s) on one or more financial reports.
Number of Copies and Mailing Address. An original and two (2) copies of the reports(s) shall be sent to the contracting officer at the address shown on the face page of the contract, no later that 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.
(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 of more years, and sensitive items regardless of cost.
1
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. Includes 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 Expenses. 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.
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
2
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.
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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
1
receives comments on the routine uses which would result in a contrary determination.
address: Please submit comments to: NIH Privacy Act Officer, Building 31, Room 1BO5, 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
2
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.
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
3
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 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. Itte?lag,
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).
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CATEGORIES OF RECORDS IN THE SYSTEM:
The system contains data about individuals as relevant to a particular research study. Examples include, but are not limited to: Name, study identification number, address, relevant telephone numbers, Social Security Number (voluntary), driver’s license number, date of birth, weight, height, sex, race; medical, psychological and dental information, laboratory and diagnostic testing results; registries; social, economic and demographic data; health services utilization; insurance and hospital cost data, employers, conditions of the work environment, exposure to hazardous substances/compounds; information pertaining to stored biologic specimens (including blood, urine, tissue and genetic materials), characteristics and activities of health care providers and educators and trainers (including curriculum vitae); and associated correspondence.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
“Research and Investigation,” “Appointment and Authority of the Directors of the National Research Institutes,” “National Cancer Institute,” “National Eye Institute,” “National Heart, Lung and Blood-Institute,” “National Institute on Aging,” “National Institute on Alcohol Abuse and Alcoholism,” “National Institute on Allergy and Infectious Diseases,” “National Institute of Arthritis and Musculoskeletal and Skin Diseases,” “ National Institute of Child Health and Human Development,” “National Institute on Deafness and Other Communication Disorders,” “National Institute of Dental Research,” “National Institute of Diabetes, and Digestive and Kidney Diseases,” “National Institute of Drug Abuse,” “National Institute of Environmental Health Sciences,” “National Institute of Mental Health,” “National Institute of Neurological Disorders and Stroke,” and the “National Center for Human Genome Research,” of the Public Health Service Act. (42 U.S.C. 241, 242, 248, 281, 282, 284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 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]]
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record is provided in individually identifiable form, and (2) warrants the risk to the privacy of the individual that additional exposure of the record might bring; (C) has required the recipient to (1) establish reasonable administrative, technical, and physical safeguards to prevent unauthorized use or disclosure of the record, (2) remove or destroy the information that identifies the individual at the earliest time at which removal or destruction can be accomplished consistent with the purpose of the research project, unless the recipient has presented adequate justification of a research or health nature for retaining such information, and (3) make no further use or disclosure of the record except (a) in emergency circumstances affecting the health or safety of any individual, (b) for use in another research project, under these same conditions, and with written authorization of the Department, (c) for disclosure to a property identified person for the purpose of an audit related to the research project, if information that would enable research subjects to be identified is removed or destroyed at the earliest opportunity consistent with the purpose of the audit, or (d) when required by law; and (D) has secured a written statement attesting to the recipient’s understanding of, and willingness to abide by, these provisions.
2. Disclosure may be made to a Member of Congress or to a Congressional staff member in response to an inquiry of the Congressional office made at the written request of the constituent about whom the record is maintained.
3. The Department of Health and Human Services (HHS) may disclose information from this system of records to the Department of Justice when; (a) The agency or any component thereof; or (b) any employee of the agency in his or her official capacity where the Department of Justice has agreed to represent the employee: or (c) the United States Government, is a party to litigation or has an interest in such litigation, and by careful review, the agency determines that the records are both relevant and necessary to the litigation and the use of such records by the Department of Justice is therefore deemed by the agency to be for a purpose that is compatible with the purpose for which the agency collected the records.
4. Disclosure may be made to agency contractors, grantees, experts, consultants, collaborating researchers, or volunteers who have been engaged by the agency to assist in the performance of a service related to this system of records and who need to have access to the records in order to perform the activity. Recipients shall be required to comply with the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
5. Information from this system may be disclosed to Federal agencies, State agencies (including the Motor Vehicle Administration and State vital statistics offices, private agencies, and other third parties (such as current or prior employers, acquaintances, relatives), when necessary to obtain information on morbidity and mortality experiences and to locate individuals for follow-up studies. Social Security numbers, date of birth and other identifiers may be disclosed: (1) To the National Center for Health Statistics to ascertain vital status through the National Death Index; (2) to the Health Care Financing Agency to ascertain morbidities; and (3) to the Social Security Administration to ascertain disabilities and/or location of
6
participants. Social Security numbers may also be given to other Federal agencies, and State and local agencies when necessary to locating individuals for participation in follow-up studies.
6. Medical information may be disclosed in identifiable form to tumor registries for maintenance of health statistics, e.g., for use in epidemiologic studies.
7. (a). PHS may inform the sexual and/or needle-sharing partner(s) of a subject individual who is infected with the human immunodeficiency virus (HIV) of their exposure to HIV, under the following circumstances: (1) The information has been obtained in the course of clinical activities at PHS facilities carried out by PHS personnel or contractors; (2) the PHS employee or contractor has made reasonable efforts to counsel and encourage the subject individual to provide the information to the individual’s sexual or needle-sharing partner(s); (3) The PHS employee or contractor determines that the subject individual is unlikely to provide the information to the sexual or needle-sharing partner(s) or that the provision of such information cannot reasonably be verified; and (4) The notification of the partner(s) is made, whenever possible, by the subject individual’s physician or by a professional counselor and shall follow standard counseling practices.
(b). PHS may disclose information to State or local public health departments, to assist in the notification of the subject individual’s sexual and/or needle-sharing partner(s), or in the verification that the subject individual has notified such sexual or needle-sharing partner(s).
8. Certain diseases and conditions, including infectious diseases, may be reported to appropriate representatives of State or Federal Government as required by State or Federal law.
9. Disclosure may be made to authorized organizations which provide health services to subject individuals or provide third-party reimbursement or fiscal intermediary functions, for the purpose of planning for or providing such services, billing or collecting third-party reimbursements.
10. The Secretary may disclose information to organizations deemed qualified to carry out quality assessment, medical audits or utilization reviews.
11. Disclosure may be made for the purpose of reporting child, elder or spousal abuse or neglect or any other type of abuse or neglect as required by State or Federal law.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records may be stored on index cards, file folders, computer tapes and disks (including optical disks), photography media, microfiche, microfilm, and audio and video tapes. For certain studies, factual data with study code numbers are stored on computer tape or disk, while the key to personal identifiers is stored separately, without factual data, in paper/computer files.
RETRIEVABILITY:
During data collection stages and follow-up, retrieval is by
7
personal identifier (e.g., name, Social Security Number, medical record or study identification number, etc.). During the data analysis stage, data are normally retrieved by the variables of interest (e.g., diagnosis, age, occupation).
SAFEGUARDS:
1. Authorized Users: Access to identifiers and to link files is strictly limited to the authorized personnel whose duties require such access. Procedures for determining authorized access to identified data are established as appropriate for each location. Personnel, including contractor personnel, who may be so authorized include those directly involved in data collection and in the design of research studies, e.g., interviewers and interviewer supervisors; project managers; and statisticians involved in designing sampling plans. Other one-time and special access by other employees is granted on a need-to-know basis as specifically authorized by the system manager.
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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, confidentially, 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 fro 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,
8
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.
SYSTEM MANAGER(S) AND ADDRESS:
See Appendix 1 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
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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
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) DataSystem, 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
10
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 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
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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
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 SQS49
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 of Drug Abuse (NIDA)
Privacy Act Coordinator, NIDA, NIH
Parklawn Building, Room 10A-42
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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
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
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[[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
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
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Frederick, MD 21701
Deputy Branch Chief, Navy Hospital
NCI—Naval Medical Oncology Branch, DCT, NCI, NIH
Building 8, Room 5101
Bethesda, MD 20814
Chief, Pharmaceutical Management Branch
Cancer Therapy Evaluation Program, DCT, NCI, NIH
Executive Plaza North, Suite 804
Bethesda, MD 20892
Director, Extramural Clinical Studies, BRB, BRMP, DCT, NCI, NIH
Frederick Cancer Research and Development Center
Fort Detrick
Frederick, MD 21701
National Eye Institute
Clinical Director, NEI, NIH
Building 10, Room 10N-202
10 Center Drive
Bethesda, MD 20892
Director, Division of Biometry and Epidemiology, NEI, NIH
Building 31, Room 6A-52
31 Center Drive
Bethesda, MD 20892
National Heart Lung and Blood Institute
Administrative Officer, Division of Intramural Research, NHLBI, NIH
Building 10 Room 7N220
10 Center Drive, MSC 1670
Bethesda, MD 20892-1670
Senior Scientific Advisor, OD
Division of Epidemiology and Clinical Applications, NHLBI, NIH
Federal Building, 220
7550 Wisconsin Avenue
Bethesda, MD 20892
National Institute on Aging
Computer Scientist, Longitudinal Studies Branch, IRP, NIH
Gerontology Research Center, GRC
4940 Eastern Avenue
Baltimore, MD 21224
Associate Director, Epidemiology,
Demography and Biometry Program, NIA, NIH
Gateway Building, Suite 3C309
7201 Wisconsin Avenue
Bethesda, MD 20892
National Institute on Alcohol Abuse and Alcoholism
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Deputy Director, Division of Biometry and Epidemiology, NIAAA, NIH
Willco Building, Suite 514
6000 Executive Blvd., MSC 7003
Bethesda, MD 20892-7003
Deputy Director, Div. of Clinical and Prevention Res., NIAAA, NIH
Willco Building, Suite 505
6000 Executive Blvd., MSC 7003
Bethesda, MD 20892-7003
National Institute of Allergy and Infectious Diseases
Chief, Respiratory Viruses Section, LID, NIAID, NIH
Building 7, Room 106
9000 Rockville Pike
Bethesda, MD 20892
Chief, Hepatitis Virus Section, LID, NIAID, NIH
Building 7, Room 202
9000 Rockville Pike
Bethesda, MD 20892
Chief, Epidemology and Biometry Branch, DMID, NIAID, NIH
Solar Building, Room 3A24
Bethesda, 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
16
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
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
17
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
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
18
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
[FR Doc. 97-8592 Filed 4-4-97; 8:45 am]
BILLING CODE 4140-01-M
19
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)
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 - | | Phonographic 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) | | | | |
OMB Bulletin 81-16 | | | | ATTACHMENT 8 |
SCHEDULE I-B
ITEM | | QUANTITY | |
| | | |
LN2 Freezer, XLC-1830 | | 10 | | |
Racking System for LN2’s | | 10 | | |
Additional LN2 Vacuum Piping | | 1 | | |
-70ºC So-Low Chest Freezers | | 75 | | |
Racking System for -70ºC’s | | 75 | | |
Controlled Rate Freezer | | 1 | | |
Bar Coding Scanner | | 1 | | |
Computers | | 5 | | |
Cryo-Shipper | | 5 | | |
Flammable Storage Unit | | 1 | | |
Slide Storage Cabinet | | 1 | | |
Government Property Schedule 11-A
“Laboratory Support for Processing and Storage of Biological Specimens”
Job# | | Item # | | Piece# | | Description | | Gfp or
Cap | | Class | | Mfr | | Model | | Serial No | | Cost | | Gov ID |
129 | | OMF | | 051 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 1,780 | | 01029103 |
129 | | OMF | | 053 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 1,780 | | 01029102 |
129 | | OMF | | 055 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 1,780 | | 01029104 |
129 | | OMF | | 056 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,680 | | 01029124 |
129 | | OMF | | 057 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,539 | | 01029117 |
129 | | OMF | | 058 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,850 | | 01029105 |
129 | | OMF | | 059 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,729 | | 01029129 |
129 | | OMF | | 060 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,539 | | 01029118 |
129 | | OMF | | 061 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | 69929-77 | | $ | 4,539 | | 01029116 |
129 | | OMF | | 062 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,850 | | 01029106 |
129 | | OMF | | 063 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | 60091-118 | | $ | 4,539 | | 01029119 |
129 | | OMF | | 064 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | 60091-119 | | $ | 4,539 | | 01029120 |
129 | | OMF | | 066 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,732 | | 01029121 |
129 | | OMF | | 067 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,680 | | 01029123 |
129 | | OMF | | 068 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,680 | | 01029125 |
129 | | OMF | | 069 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | 11611-479 | | $ | 4,680 | | 01029126 |
129 | | OMF | | 070 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,275 | | 01029127 |
129 | | OMF | | 071 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,275 | | 01029128 |
129 | | OMF | | 072 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,857 | | 01029130 |
129 | | OMF | | 073 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,857 | | 01029131 |
129 | | OMF | | 074 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,857 | | 01029132 |
129 | | OMF | | 075 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | 13029-220 | | $ | 4,743 | | 01029133 |
129 | | OMF | | 076 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,743 | | 01029134 |
129 | | OMF | | 077 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,743 | | 01029135 |
129 | | OMF | | 078 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | 13071-255 | | $ | 4,743 | | 01029136 |
129 | | OMF | | 079 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | SE27,120 | | 13071-256 | | $ | 4,503 | | 1023092 |
129 | | OMF | | 080 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 5,028 | | 1029137 |
129 | | OMF | | 081 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 5,028 | | 1029138 |
129 | | OMF | | 082 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | SE27,120 | | ???? | | $ | 4,053 | | 1023091 |
129 | | OMF | | 083 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,473 | | 00811080 |
129 | | OMF | | 084 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 4,473 | | 00811081 |
129 | | OMF | | 085 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 5,431 | | 00811940 |
129 | | OMF | | 086 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 5,431 | | 00811941 |
129 | | OMF | | 087 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | SE27,120 | | ???? | | $ | 5,243 | | 00871523 |
129 | | OMF | | 088 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | SE27,120 | | ???? | | $ | 5,243 | | 00871522 |
129 | | OMF | | 089 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 6,748 | | 01175129 |
129 | | OMF | | 090 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 6,748 | | 01175130 |
129 | | OMF | | 091 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 7,050 | | 01096558 |
129 | | OMF | | 092 | | Mechanical Freezer | | CAP | | Under | | FORMA | | ???? | | ???? | | $ | 7,050 | | 01096559 |
129 | | OMF | | 093 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | C15-27 | | ???? | | $ | 8,792 | | 01182917 |
129 | | OMF | | 094 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | C15-27 | | ???? | | $ | 10,080 | | 01190561 |
129 | | OMF | | 095 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | C15-27 | | ???? | | $ | 9,318 | | 01190562 |
129 | | OMF | | 096 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | C15-27 | | ???? | | $ | 9,318 | | 01190563 |
129 | | OMF | | 048 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | C15-27 | | ???? | | $ | 8,993 | | 01264713 |
129 | | OMF | | 047 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | C15-27 | | ???? | | $ | 8,993 | | 01264714 |
129 | | OMF | | 045 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | ???-27 | | ???? | | $ | 9,268 | | 01250392 |
129 | | OMF | | 046 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | ???-27 | | ???? | | $ | 9,268 | | 01250393 |
1
129 | | OMF | | 043 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | ????-27 | | 9697237 | | $ | 9,808 | | 01213988 |
129 | | OMF | | 044 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | ????-27 | | 9697236 | | $ | 9,808 | | 01213989 |
129 | | OMF | | Mbu1 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | ????-27 | | 9697420 | | $ | 5,525 | | 01264570 |
129 | | OMF | | Mbu2 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | ????-27 | | 9697421 | | $ | 5,525 | | 01264571 |
129 | | OMF | | #Mbu3 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | ????-27 | | ???? | | $ | 5,525 | | 01264572 |
129 | | OMF | | #Mbu4 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | ????-27 | | ???? | | $ | 5,525 | | 01264573 |
129 | | OMF | | #Mbu5 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | ????-27 | | ???? | | $ | 5,525 | | 01264574 |
129 | | OMF | | #Mbu6 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | ????-27 | | ???? | | $ | 5,525 | | 01264575 |
129 | | OMF | | #Mbu7 | | Mechanical Freezer | | CAP | | Under | | SOLOW | | ????-27 | | ???? | | $ | 5,525 | | 01264576 |
129 | | OMF | | M1A | | Cntrl Rare Frz-Prog | | CAP | | Under | | ???? | | ???? | | ???? | | $ | 9,870 | | 01029113 |
129 | | OMF | | M1B | | CRF-Chamber | | CAP | | Under | | ???? | | ???? | | ???? | | | | 01029113 |
129 | | OMF | | M2A | | Cntrl Rare-Controller | | CAP | | Under | | ???? | | 1010 | | ???? | | $ | 10,754 | | 01029157 |
129 | | OMF | | M2B | | CRF-Recorder | | CAP | | Under | | ???? | | ???? | | ???? | | | | 01029157 |
129 | | OMF | | M2C | | CRF-Chamber | | CAP | | Under | | ???? | | ???? | | ???? | | | | 01029157 |
129 | | OMF | | M3 | | LN2 Tank | | CAP | | Under | | ???? | | ???? | | ???? | | $ | 1,295 | | 1029156 |
129 | | OMF | | M4 | | LN2 Dry Shipper | | CAP | | Under | | ???? | | CMD-20 | | CMD-20-1 | | $ | 1,100 | | 1029156 |
129 | | OMF | | M5 | | Laminar Flow Hood | | CAP | | Under | | ???? | | ???? | | ???? | | $ | 1,182 | | |
129 | | OMF | | M6 | | Laminar Flow Hood | | CAP | | Under | | CCI | | ???? | | ???? | | $ | 8,952 | | |
129 | | OMF | | M7 | | Refrigerator | | CAP | | Under | | ???? | | ???? | | ???? | | $ | 880 | | |
129 | | OMF | | M8 | | Water Bath | | CAP | | Under | | ???? | | ???? | | ???? | | $ | 450 | | |
129 | | OMF | | M10 | | Hood, BioSafety | | CAP | | Under | | ???? | | ???? | | ???? | | $ | 3,860 | | |
129 | | OMF | | M11 | | Freezer, Vertical | | CAP | | Under | | ???? | | ???? | | ???? | | $ | 580 | | |
129 | | OMF | | M12 | | Freezer, Vertical | | CAP | | Under | | ???? | | ???? | | ???? | | $ | 580 | | |
129 | | OMF | | M13 | | Microscope | | CAP | | Under | | ???? | | ???? | | ???? | | $ | 11,956 | | |
129 | | OMF | | M14 | | Generator | | CAP | | Over | | ???? | | ???? | | ???? | | $ | 40,300 | | |
129 | | OMF | | M15 | | Walk-in Refrigerator | | CAP | | Under | | ???? | | ???? | | ???? | | $ | 7,776 | | |
129 | | OMF | | M16 | | Walk-in Freezer | | CAP | | Under | | ???? | | ???? | | ???? | | $ | 9,250 | | |
2
GOVERNMENT PROPERTY - SCHEDULE
| | |
CONTRACTOR: | | CONTRACT NUMBER |
| | |
| | |
| | |
ADDRESS | | REPORT DATE: |
| | |
| | |
| | |
| | FISCAL YEAR: |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
SIGNED BY: | | DATE SIGNED: |
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Report of Government Owned, Contractor Held Property
