SECTION I CONTRACT CLAUSES Additional Contract Clauses The following information is specific to this solicitation and is provided to supplement and or complete the associated ITEMS presented at th by Adela Sanders

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									SECTION I - CONTRACT CLAUSES: Additional Contract Clauses

The following information is specific to this solicitation and is provided to supplement
and/or complete the associated ITEMS presented at the SECTION I website at
http://rcb.cancer.gov/rcb-internet/wkf/sectioni.pdf


                                              I.1. General Clauses

The following General Clause Listings will be applicable to most contracts resulting from this RFP. However, the
organizational structure of the successful offeror(s) will determine the specific General Clause Listing to be contained in
the contract(s) awarded from this RFP:

    General Clauses for a Cost-Reimbursement Research and Development Contract


The complete listing of these clauses may be accessed at: http://rcb.cancer.gov/rcb-internet/clauses/clauses.html




                              I.2. Authorized Substitutions of Clauses

Item 8:     Alternate II (OCTOBER 2001) of FAR Clause 52.219-9, Small Business Subcontracting Plan
            (OCTOBER 2001) is added.

Item 12:    FAR Clause 52.232-20, Limitation of Cost, is deleted in its entirety and FAR Clause 52.232-22, Limitation
            of Funds (APRIL 1984) is substituted therefor. [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.




                                     I.3. Additional Contract Clauses
a. Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clauses

The resultant contract will incorporate the clauses in this section by reference, (unless otherwise noted), 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 .

Item 18:    FAR Clause 52.215-17, Waiver of Facilities Capital Cost of Money (OCTOBER 1997) Is applicable to this
            solicitation.

Item 40:    FAR Clause 52.224-1, Privacy Act Notification (APRIL 1984), is applicable to this solicitation.

Item 43:    FAR Clause 52.227-14 Rights in Data - General (JUNE 1987), is applicable to this solicitation.

Item 44:    The following Alternate(s) is/are applicable to this solicitation:

            Alternate I (JUNE 1987), FAR Clause 52.227-14, Rights in Data--General (JUNE 1987).

            Alternate II (JUNE 1987), FAR Clause 52.227-14, Rights in Data--General (JUNE 1987).

                  Additional purposes for which the limited rights data may be used are:


Item 49:    FAR Clause 52.227-23, Rights to Proposal Data (Technical) (JUNE 1987), is applicable to this solicitation.



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           Excluded pages from the proposal dated               *, are identified as follows:

                  *Information to be determined during negotiations.

Item 50:   FAR Clause 52.2300-3, Disclosure and Consistency of Cost Accounting Practices (APRIL 1998), is
           applicable to this solicitation.

Item 55:   FAR Clause 52.239-12, Privacy or Security Safeguards (AUGUST 1996), is applicable to this solicitation.

Item 60:   FAR Clause 52.246-23, Limitation of Liability (FEBRUARY 1997), is applicable to this solicitation.


b. Department of Health and Human Services Acquisition Regulation (HHSAR) (48 CFR Chapter 3)
Clauses:

Item 67:   HHSAR Clause 352.270-1, Accessibility of Meetings,(FEBRUARY 1997), is applicable to this solicitation.

Item 68: HHSAR Clause 352.270-8, Protection of Human Subjects (JANUARY 2001), is applicable to this
         solicitation.


c. National Institutes of Health (NIH) Research Contracting (RC) Clauses):

Item 70: NIH (RC) Clause NIH(RC)-7, Procurement of Certain Equipment (APRIL 1984), is applicable
         to this solicitation.


                 I.4. Additional FAR Contract Clauses Included in Full Text:


See I.4. Additional FAR Contract Clauses Included in Full Text of SECTION I at
http://rcb.cancer.gov/rcb-internet/wkf/sectioni.pdf for the general listing of Additional FAR Contract Clauses
Included in Full Text.

Item 75: FAR Clause 52.244-6, Subcontracts for Commercial Items (APRIL 2003)

(a)   Definitions. As used in this clause–

      Commercial item, has the meaning contained in the clause at 52.202-1, Definitions.

      Subcontract, includes a transfer of commercial items between divisions, subsidiaries, or affiliates of the
      Contractor or subcontractor at any tier.

(b)   To the maximum extent practicable, the Contractor shall incorporate, and require its subcontractors at
      all tiers to incorporate, commercial items or non developmental items as components of items to be
      supplied under this contract.

(c) (1)    The Contractor shall insert the following clauses in subcontracts for commercial items:

           (i)   52.219-8, Utilization of Small Business Concerns (OCT 2000) (15 U.S.C. 637(d)(2) and
                 (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract
                 (except subcontracts to small business concerns) exceeds $500,000 ($1,000,000 for
                 construction of any public facility), the subcontractor must include 52.219.8 in lower tier
                 subcontracts that offer subcontracting opportunities.
           (ii) 52.222-26, Equal Opportunity (APR 2002) (E.O. 11246).
           (iii) 52.222-35, Equal Opportunity for Special Disables Veterans, Veterans of the Vietnam
                 Era, and Other Eligible Veterans (DEC 2001) (38 U.S.C. 4212 (a)).
           (iv) 52.222-36, Affirmative Action for Workers with Disabilities (JUN 1998) (29 U.S.C.
                 793).

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             (v)   52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (APR
                   2003))46 U.S.C. Appx 1241 and 10 U.S.C. 2631) (flow down required in accordance with
                   paragraph (d) of FAR clause 52.247-64).

       (2)   While not required, the Contractor may flow down to subcontracts for commercial items a minimal
             number of additional clauses necessary to satisfy the contractual obligations.

(d)    The Contractor shall include the terms of this clause, including this paragraph (d), in subcontracts
       awarded under this contract.


NOTE:        The following are special NHLBI contract requirements, and the following clauses will
             appear in any resultant contracts.

SECTION H.         SPECIAL CONTRACT REQUIREMENTS

Item 1.      ARTICLE H. .       NHLBI Limited Access Data Clause (March 2001)

      The National Heart, Lung, and Blood Institute (NHLBI) has supported collection of data from
      participants in numerous clinical trials and epidemiologic studies. These well-characterized population
      samples represent rare and valuable scientific resources. In order to take full advantage of such
      resources and maximize their research value, it is important that data collected with public funds be
      made available, under appropriate terms and conditions, to the largest possible number of qualified
      investigators in a timely manner.

      Limited access data will be released under this trial or study. Limited access data refers to trial or
      study data, with certain deletions and recoding, that are released to requesting institutions and
      investigators for specific purposes and with certain restrictions and conditions. Limited access data will
      be made available to the public in accordance with the NHLBI Policy for Distribution of Data
      (http://www.nhlbi.nih.gov/resources/deca/policy.htm.)

      Limited access data is a deliverable under the coordinating center contract for this trial or study, as
      described in Section C. Description/Specification/Work Statement and/or Section F. Deliveries or
      Performance of the coordinating center contract.

Item 2.      ARTICLE H.     . Review of Manuscripts

       In order to balance the oversight responsibility of the National Heart, Lung, and Blood Institute
       (NHLBI) with the authorization provided the contractor by the Rights in Data clause of this contract,
       the NHLBI has established a process to review manuscripts produced under this contract. Please note
       that the NHLBI does not require contractors to seek the Institute’s approval of manuscripts.

       In order to have sufficient time to conduct a meaningful review, please provide to the Institute’s
       Project Officer and Contracting Officer advance notice of intent to submit a manuscript for publication
       at least 45 days prior to submission to the publisher. The advance notice should briefly describe the
       plans for publication of the manuscript. Concurrently or as soon as possible following this notice,
       please provide the manuscript just to the Project Officer.

       Any comments from the NHLBI will be provided in writing within 15 days after receipt of the
       manuscript by the Project Officer. Comments expressed by the NHLBI about the manuscript shall not
       be a cause for action under the Disputes clause of the contract by either NHLBI or the contractor,
       since the NHLBI does not approve manuscripts and draft manuscripts are not contract deliverables.

Item 3:      ARTICLE H.     .    INFORMATION TECHNOLOGY APPLICATION/SYSTEM SECURITY PLAN

      Note: The information technology elements of clinical and epidemiological trials are defined by Center
      for Information Technology, NIH as major applications.


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   ARTICLE H. . INFORMATION TECHNOLOGY APPLICATION/SYSTEM SECURITY PLAN

   The Contractor shall comply with the information technology application/system security protection
   requirements set forth in the Application/System Security Plan (attachment ). The Contractor shall
   include this provision in any subcontract awarded pursuant to this prime contract, as applicable.

   Information Technology Application/System Security Plan

   a.     This project involves a “major application” as defined under OMB Circular A-130 - Management
          of Federal Information Resources: Appendix III - Security of Federal Automated Information
          Resources. A “major application”
          requires special attention to security due to the risk and magnitude of the harm resulting from
          the loss, misuse, or unauthorized access to or modification of the information in the application.

   b.     The proposal shall present a detailed outline of its proposed information technology
          application/system security plan which complies with the requirements set forth below and in
          the Statement of Work, the Computer Security Act of 1987, Office of Management and Budget
          (OMB) Circular A-130 - Management of Federal Information Resources: Appendix III - Security
          of Federal Automated Information Systems, and the DHHS Automated Information Systems
          Security Program Handbook (Release 2.0, dated May, 1994.)
          (http://wwwoirm.nih.gov/policy/aissp.html.) The information technology application/system
          security plan shall be prepared and submitted using the NIH Application/Systems Security
          Template (http://irm.cit.nih.gov/security/secplantemp.html), or the NHLBI Application/Systems
          Security Template (Word Perfect9 version)
          (http://insider.nhlbi.nih.gov/dea_cob/policy.htm#ITSS.) The proposal shall also present similar
          information for any subcontract proposed, as applicable.


                             APPLICATION/SYSTEM PROTECTION REQUIREMENTS
                                  Confidentiality         Integrity
           Information           (High, Medium,        (High, Medium,            Availability
           Type                        Low)                 Low)            (High, Medium, Low)
           Administrative
           Financial
           Grant/Contract
           Patient
           Proprietary
           Research
           Privacy Act
           Other (specify)




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