**U.S. Department of Health and Human Services, National Institutes of
Health**

National Institute of Allergy and Infectious Diseases (NIAID)

**RFP-NIH-NIAID-DAIT-07-33**

**"Collaborative Network for Clinical Research on Immune Tolerance"**

+----------------+-----+---+---+--------+--------+---+---+------------------------+
| 1.  **OFFERORS |     |   |   |        |        |   |   |                        |
|     ARE        |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|    RESPONSIBLE |     |   |   |        |        |   |   |                        |
|     FOR        |     |   |   |        |        |   |   |                        |
|     ROUTINELY  |     |   |   |        |        |   |   |                        |
|     CHECKING   |     |   |   |        |        |   |   |                        |
|     THE        |     |   |   |        |        |   |   |                        |
|     FOLLOWING  |     |   |   |        |        |   |   |                        |
|     WEBSITE    |     |   |   |        |        |   |   |                        |
|     FOR ANY    |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|   SOLICITATION |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|    AMENDMENTS. |     |   |   |        |        |   |   |                        |
|     NO         |     |   |   |        |        |   |   |                        |
|     ADDITIONAL |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|   NOTIFICATION |     |   |   |        |        |   |   |                        |
|     OF ANY     |     |   |   |        |        |   |   |                        |
|     AMENDMENTS |     |   |   |        |        |   |   |                        |
|     WILL BE    |     |   |   |        |        |   |   |                        |
|     PROVIDED   |     |   |   |        |        |   |   |                        |
|     BY THIS    |     |   |   |        |        |   |   |                        |
|     OFFICE.    |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|   http://www.F |     |   |   |        |        |   |   |                        |
| edbizops.gov** |     |   |   |        |        |   |   |                        |
+----------------+-----+---+---+--------+--------+---+---+------------------------+
| 2.  **SECTION  |     |   |   |        |        |   |   |                        |
|     A --       |     |   |   |        |        |   |   |                        |
|     SOLICIT    |     |   |   |        |        |   |   |                        |
| ATION/CONTRACT |     |   |   |        |        |   |   |                        |
|     FORM \--   |     |   |   |        |        |   |   |                        |
|     PURCHASE   |     |   |   |        |        |   |   |                        |
|     AUTHORITY: |     |   |   |        |        |   |   |                        |
|     FAR        |     |   |   |        |        |   |   |                        |
|     1.602-1**  |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
| NOTE: The      |     |   |   |        |        |   |   |                        |
| issuance of    |     |   |   |        |        |   |   |                        |
| this           |     |   |   |        |        |   |   |                        |
| solicitation   |     |   |   |        |        |   |   |                        |
| does not       |     |   |   |        |        |   |   |                        |
| commit the     |     |   |   |        |        |   |   |                        |
| government to  |     |   |   |        |        |   |   |                        |
| an award.      |     |   |   |        |        |   |   |                        |
+----------------+-----+---+---+--------+--------+---+---+------------------------+
| 3.  **Issue    | 4.  |   |   |        |        |   |   | 5.  **Small Bus.       |
|     Date:**    |  ** |   |   |        |        |   |   |     Set-Aside:** \[    |
|                | Due |   |   |        |        |   |   |     \]Yes \[X\] No     |
| February 3,    |     |   |   |        |        |   |   |                        |
| 2006           |   D |   |   |        |        |   |   | > **8(a) Set-Aside:**  |
|                | ate |   |   |        |        |   |   | > \[ \]Yes \[X\] No    |
|                | :** |   |   |        |        |   |   | >                      |
|                |     |   |   |        |        |   |   | > (See Part IV,        |
|                |   J |   |   |        |        |   |   | > Section L.)          |
|                | une |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|                |  5, |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|                |   2 |   |   |        |        |   |   |                        |
|                | 006 |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|                | >   |   |   |        |        |   |   |                        |
|                | **T |   |   |        |        |   |   |                        |
|                | ime |   |   |        |        |   |   |                        |
|                | :** |   |   |        |        |   |   |                        |
|                | > 3 |   |   |        |        |   |   |                        |
|                | :00 |   |   |        |        |   |   |                        |
|                | >   |   |   |        |        |   |   |                        |
|                | PM, |   |   |        |        |   |   |                        |
|                | >   |   |   |        |        |   |   |                        |
|                | EST |   |   |        |        |   |   |                        |
+----------------+-----+---+---+--------+--------+---+---+------------------------+
|                |     |   |   |        |        |   |   |                        |
+----------------+-----+---+---+--------+--------+---+---+------------------------+
| 6.             |     | 7 |   |        |        |   | 8 |                        |
|   **[Mandatory |     | . |   |        |        |   | . |                        |
|                |     |   |   |        |        |   |   |                        |
|  Qualification |     |   |   |        |        |   |   |                        |
|     Cr         |     | * |   |        |        |   | * |                        |
| iteria](#V):** |     | * |   |        |        |   | * |                        |
|                |     | N |   |        |        |   | [ |                        |
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|                |     |   |   |        |        |   | a |                        |
|                |     |   |   |        |        |   | l |                        |
|                |     |   |   |        |        |   | . |                        |
|                |     |   |   |        |        |   | h |                        |
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|                |     |   |   |        |        |   | m |                        |
|                |     |   |   |        |        |   | > |                        |
+----------------+-----+---+---+--------+--------+---+---+------------------------+
|                |     |   |   |        |        |   |   |                        |
+----------------+-----+---+---+--------+--------+---+---+------------------------+
| 9.  **Issued   |     |   |   | \[X\]  |        |   |   |                        |
|     By:**      |     |   |   | **N    |        |   |   |                        |
|                |     |   |   | IAID** |        |   |   |                        |
| Erin Goldstein |     |   |   | **re   |        |   |   |                        |
|                |     |   |   | serves |        |   |   |                        |
| Contracting    |     |   |   | the    |        |   |   |                        |
| Officer        |     |   |   | right  |        |   |   |                        |
|                |     |   |   | to     |        |   |   |                        |
| Office of      |     |   |   | make   |        |   |   |                        |
| Acquisitions   |     |   |   | awards |        |   |   |                        |
| (OA) DEA       |     |   |   | w      |        |   |   |                        |
|                |     |   |   | ithout |        |   |   |                        |
| NIH, NIAID     |     |   |   | d      |        |   |   |                        |
|                |     |   |   | iscuss |        |   |   |                        |
| 6700-B         |     |   |   | ion.** |        |   |   |                        |
| Rockledge      |     |   |   |        |        |   |   |                        |
| Drive          |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
| Room 3214, MSC |     |   |   |        |        |   |   |                        |
| 7612           |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
| Bethesda, MD   |     |   |   |        |        |   |   |                        |
| 20892-7612     |     |   |   |        |        |   |   |                        |
+----------------+-----+---+---+--------+--------+---+---+------------------------+
|                |     |   |   | **11.  |        | * |   |                        |
|                |     |   |   | [      |        | * |   |                        |
|                |     |   |   | Pre-pr |        | 1 |   |                        |
|                |     |   |   | oposal |        | 2 |   |                        |
|                |     |   |   | Confe  |        | . |   |                        |
|                |     |   |   | rence] |        | P |   |                        |
|                |     |   |   | (#M)** |        | e |   |                        |
|                |     |   |   |        |        | r |   |                        |
|                |     |   |   | Not    |        | i |   |                        |
|                |     |   |   | Appl   |        | o |   |                        |
|                |     |   |   | icable |        | d |   |                        |
|                |     |   |   |        |        | o |   |                        |
|                |     |   |   |        |        | f |   |                        |
|                |     |   |   |        |        | P |   |                        |
|                |     |   |   |        |        | e |   |                        |
|                |     |   |   |        |        | r |   |                        |
|                |     |   |   |        |        | f |   |                        |
|                |     |   |   |        |        | o |   |                        |
|                |     |   |   |        |        | r |   |                        |
|                |     |   |   |        |        | m |   |                        |
|                |     |   |   |        |        | a |   |                        |
|                |     |   |   |        |        | n |   |                        |
|                |     |   |   |        |        | c |   |                        |
|                |     |   |   |        |        | e |   |                        |
|                |     |   |   |        |        | : |   |                        |
|                |     |   |   |        |        | * |   |                        |
|                |     |   |   |        |        | * |   |                        |
|                |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        | 7 |   |                        |
|                |     |   |   |        |        | y |   |                        |
|                |     |   |   |        |        | e |   |                        |
|                |     |   |   |        |        | a |   |                        |
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|                |     |   |   |        |        | a |   |                        |
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|                |     |   |   |        |        | t |   |                        |
|                |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        | F |   |                        |
|                |     |   |   |        |        | e |   |                        |
|                |     |   |   |        |        | b |   |                        |
|                |     |   |   |        |        | r |   |                        |
|                |     |   |   |        |        | u |   |                        |
|                |     |   |   |        |        | a |   |                        |
|                |     |   |   |        |        | r |   |                        |
|                |     |   |   |        |        | y |   |                        |
|                |     |   |   |        |        | 1 |   |                        |
|                |     |   |   |        |        | , |   |                        |
|                |     |   |   |        |        | 2 |   |                        |
|                |     |   |   |        |        | 0 |   |                        |
|                |     |   |   |        |        | 0 |   |                        |
|                |     |   |   |        |        | 7 |   |                        |
|                |     |   |   |        |        | . |   |                        |
+----------------+-----+---+---+--------+--------+---+---+------------------------+
| 13\. Primary   |     |   | * |        |        |   |   | **15. Protest          |
| Point of       |     |   | * |        |        |   |   | Officer:**             |
| Contact:       |     |   | 1 |        |        |   |   |                        |
|                |     |   | 4 |        |        |   |   | Charles W. Grewe       |
| Name : Erin    |     |   | . |        |        |   |   |                        |
| Goldstein      |     |   | S |        |        |   |   | > Director, OA         |
|                |     |   | e |        |        |   |   | >                      |
| **Phone:**     |     |   | c |        |        |   |   | > Address (see Block   |
| 301-496-6423   |     |   | o |        |        |   |   | > 9.)                  |
|                |     |   | n |        |        |   |   |                        |
| **Fax:**       |     |   | d |        |        |   |   |                        |
| 301-402-0972   |     |   | a |        |        |   |   |                        |
|                |     |   | r |        |        |   |   |                        |
| E-Mail:        |     |   | y |        |        |   |   |                        |
| EGoldstein     |     |   | P |        |        |   |   |                        |
| @niaid.nih.gov |     |   | o |        |        |   |   |                        |
|                |     |   | i |        |        |   |   |                        |
|                |     |   | n |        |        |   |   |                        |
|                |     |   | t |        |        |   |   |                        |
|                |     |   | o |        |        |   |   |                        |
|                |     |   | f |        |        |   |   |                        |
|                |     |   | C |        |        |   |   |                        |
|                |     |   | o |        |        |   |   |                        |
|                |     |   | n |        |        |   |   |                        |
|                |     |   | t |        |        |   |   |                        |
|                |     |   | a |        |        |   |   |                        |
|                |     |   | c |        |        |   |   |                        |
|                |     |   | t |        |        |   |   |                        |
|                |     |   | : |        |        |   |   |                        |
|                |     |   | * |        |        |   |   |                        |
|                |     |   | * |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|                |     |   | * |        |        |   |   |                        |
|                |     |   | * |        |        |   |   |                        |
|                |     |   | N |        |        |   |   |                        |
|                |     |   | a |        |        |   |   |                        |
|                |     |   | m |        |        |   |   |                        |
|                |     |   | e |        |        |   |   |                        |
|                |     |   | : |        |        |   |   |                        |
|                |     |   | * |        |        |   |   |                        |
|                |     |   | * |        |        |   |   |                        |
|                |     |   | D |        |        |   |   |                        |
|                |     |   | e |        |        |   |   |                        |
|                |     |   | b |        |        |   |   |                        |
|                |     |   | o |        |        |   |   |                        |
|                |     |   | r |        |        |   |   |                        |
|                |     |   | a |        |        |   |   |                        |
|                |     |   | h |        |        |   |   |                        |
|                |     |   | B |        |        |   |   |                        |
|                |     |   | l |        |        |   |   |                        |
|                |     |   | y |        |        |   |   |                        |
|                |     |   | v |        |        |   |   |                        |
|                |     |   | e |        |        |   |   |                        |
|                |     |   | i |        |        |   |   |                        |
|                |     |   | s |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|                |     |   | * |        |        |   |   |                        |
|                |     |   | * |        |        |   |   |                        |
|                |     |   | P |        |        |   |   |                        |
|                |     |   | h |        |        |   |   |                        |
|                |     |   | o |        |        |   |   |                        |
|                |     |   | n |        |        |   |   |                        |
|                |     |   | e |        |        |   |   |                        |
|                |     |   | : |        |        |   |   |                        |
|                |     |   | * |        |        |   |   |                        |
|                |     |   | * |        |        |   |   |                        |
|                |     |   | 3 |        |        |   |   |                        |
|                |     |   | 0 |        |        |   |   |                        |
|                |     |   | 1 |        |        |   |   |                        |
|                |     |   | - |        |        |   |   |                        |
|                |     |   | 5 |        |        |   |   |                        |
|                |     |   | 9 |        |        |   |   |                        |
|                |     |   | 4 |        |        |   |   |                        |
|                |     |   | - |        |        |   |   |                        |
|                |     |   | 7 |        |        |   |   |                        |
|                |     |   | 2 |        |        |   |   |                        |
|                |     |   | 1 |        |        |   |   |                        |
|                |     |   | 1 |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|                |     |   | * |        |        |   |   |                        |
|                |     |   | * |        |        |   |   |                        |
|                |     |   | F |        |        |   |   |                        |
|                |     |   | a |        |        |   |   |                        |
|                |     |   | x |        |        |   |   |                        |
|                |     |   | : |        |        |   |   |                        |
|                |     |   | * |        |        |   |   |                        |
|                |     |   | * |        |        |   |   |                        |
|                |     |   | 3 |        |        |   |   |                        |
|                |     |   | 0 |        |        |   |   |                        |
|                |     |   | 1 |        |        |   |   |                        |
|                |     |   | - |        |        |   |   |                        |
|                |     |   | 4 |        |        |   |   |                        |
|                |     |   | 0 |        |        |   |   |                        |
|                |     |   | 2 |        |        |   |   |                        |
|                |     |   | - |        |        |   |   |                        |
|                |     |   | 4 |        |        |   |   |                        |
|                |     |   | 6 |        |        |   |   |                        |
|                |     |   | 7 |        |        |   |   |                        |
|                |     |   | 5 |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|                |     |   | E |        |        |   |   |                        |
|                |     |   | - |        |        |   |   |                        |
|                |     |   | M |        |        |   |   |                        |
|                |     |   | a |        |        |   |   |                        |
|                |     |   | i |        |        |   |   |                        |
|                |     |   | l |        |        |   |   |                        |
|                |     |   | : |        |        |   |   |                        |
|                |     |   | d |        |        |   |   |                        |
|                |     |   | b |        |        |   |   |                        |
|                |     |   | 5 |        |        |   |   |                        |
|                |     |   | 3 |        |        |   |   |                        |
|                |     |   | 9 |        |        |   |   |                        |
|                |     |   | e |        |        |   |   |                        |
|                |     |   | @ |        |        |   |   |                        |
|                |     |   | n |        |        |   |   |                        |
|                |     |   | i |        |        |   |   |                        |
|                |     |   | h |        |        |   |   |                        |
|                |     |   | . |        |        |   |   |                        |
|                |     |   | g |        |        |   |   |                        |
|                |     |   | o |        |        |   |   |                        |
|                |     |   | v |        |        |   |   |                        |
+----------------+-----+---+---+--------+--------+---+---+------------------------+
| 16. COLLECT    |     |   |   |        |        |   |   |                        |
|     CALLS WILL |     |   |   |        |        |   |   |                        |
|     NOT BE     |     |   |   |        |        |   |   |                        |
|     ACCEPTED.  |     |   |   |        |        |   |   |                        |
|     FACSIMILE  |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|    SUBMISSIONS |     |   |   |        |        |   |   |                        |
|     ARE NOT    |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|    ACCEPTABLE. |     |   |   |        |        |   |   |                        |
+----------------+-----+---+---+--------+--------+---+---+------------------------+
| 17. Offers     |     |   |   |        |        |   |   |                        |
|     will be    |     |   |   |        |        |   |   |                        |
|     valid for  |     |   |   |        |        |   |   |                        |
|     120 days   |     |   |   |        |        |   |   |                        |
|     unless a   |     |   |   |        |        |   |   |                        |
|     different  |     |   |   |        |        |   |   |                        |
|     period is  |     |   |   |        |        |   |   |                        |
|     specified  |     |   |   |        |        |   |   |                        |
|     by the     |     |   |   |        |        |   |   |                        |
|     Offeror on |     |   |   |        |        |   |   |                        |
|     the form   |     |   |   |        |        |   |   |                        |
|     entitled   |     |   |   |        |        |   |   |                        |
|     "Proposal  |     |   |   |        |        |   |   |                        |
|     Summary    |     |   |   |        |        |   |   |                        |
|     and Data   |     |   |   |        |        |   |   |                        |
|     Record,    |     |   |   |        |        |   |   |                        |
|     NIH-2043\" |     |   |   |        |        |   |   |                        |
|     (See       |     |   |   |        |        |   |   |                        |
|     SECTION J  |     |   |   |        |        |   |   |                        |
|     --         |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|   Attachments) |     |   |   |        |        |   |   |                        |
+----------------+-----+---+---+--------+--------+---+---+------------------------+
|                |     |   |   |        |        |   |   |                        |
+----------------+-----+---+---+--------+--------+---+---+------------------------+
| 18\. DELIVERY  |     |   |   |        |        |   |   |                        |
| ADDRESS        |     |   |   |        |        |   |   |                        |
| INFORMATION    |     |   |   |        |        |   |   |                        |
+----------------+-----+---+---+--------+--------+---+---+------------------------+
| Hand Delivery  |     |   |   |        | ### U. |   |   |                        |
| or Overnight   |     |   |   |        | S. Pos |   |   |                        |
| Service:       |     |   |   |        | tal Se |   |   |                        |
|                |     |   |   |        | rvice  |   |   |                        |
| Erin Goldstein |     |   |   |        | or an  |   |   |                        |
|                |     |   |   |        | Expres |   |   |                        |
| Office of      |     |   |   |        | s Deli |   |   |                        |
| Acquisitions   |     |   |   |        | very S |   |   |                        |
| (OA), DEA      |     |   |   |        | ervice |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
| NIAID, NIH     |     |   |   |        | Erin   |   |   |                        |
|                |     |   |   |        | Gol    |   |   |                        |
| 6700-B         |     |   |   |        | dstein |   |   |                        |
| Rockledge      |     |   |   |        |        |   |   |                        |
| Drive, Room    |     |   |   |        | Office |   |   |                        |
| 3214           |     |   |   |        | of     |   |   |                        |
|                |     |   |   |        | Acquis |   |   |                        |
| Bethesda, MD   |     |   |   |        | itions |   |   |                        |
| 20817          |     |   |   |        | (OA),  |   |   |                        |
|                |     |   |   |        | DEA    |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|                |     |   |   |        | NIAID, |   |   |                        |
|                |     |   |   |        | NIH    |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|                |     |   |   |        | 6700-B |   |   |                        |
|                |     |   |   |        | Roc    |   |   |                        |
|                |     |   |   |        | kledge |   |   |                        |
|                |     |   |   |        | Drive, |   |   |                        |
|                |     |   |   |        | Room   |   |   |                        |
|                |     |   |   |        | 3214,  |   |   |                        |
|                |     |   |   |        | MSC    |   |   |                        |
|                |     |   |   |        | 7612   |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|                |     |   |   |        | Bet    |   |   |                        |
|                |     |   |   |        | hesda, |   |   |                        |
|                |     |   |   |        | MD     |   |   |                        |
|                |     |   |   |        | 2089   |   |   |                        |
|                |     |   |   |        | 2-7612 |   |   |                        |
+----------------+-----+---+---+--------+--------+---+---+------------------------+
| 19. The        |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|    **[Official |     |   |   |        |        |   |   |                        |
|     Point of   |     |   |   |        |        |   |   |                        |
|     Receipt]   |     |   |   |        |        |   |   |                        |
| {.underline}** |     |   |   |        |        |   |   |                        |
|     for the    |     |   |   |        |        |   |   |                        |
|     purpose of |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|    determining |     |   |   |        |        |   |   |                        |
|     timely     |     |   |   |        |        |   |   |                        |
|     delivery   |     |   |   |        |        |   |   |                        |
|     is the     |     |   |   |        |        |   |   |                        |
|     address    |     |   |   |        |        |   |   |                        |
|     provided   |     |   |   |        |        |   |   |                        |
|     in Block   |     |   |   |        |        |   |   |                        |
|     18, above. |     |   |   |        |        |   |   |                        |
|     The paper  |     |   |   |        |        |   |   |                        |
|     copy with  |     |   |   |        |        |   |   |                        |
|     original   |     |   |   |        |        |   |   |                        |
|     signatures |     |   |   |        |        |   |   |                        |
|     is the     |     |   |   |        |        |   |   |                        |
|     official   |     |   |   |        |        |   |   |                        |
|     copy for   |     |   |   |        |        |   |   |                        |
|     recording  |     |   |   |        |        |   |   |                        |
|     timely     |     |   |   |        |        |   |   |                        |
|     receipt.   |     |   |   |        |        |   |   |                        |
|     If the     |     |   |   |        |        |   |   |                        |
|     paper copy |     |   |   |        |        |   |   |                        |
|     of your    |     |   |   |        |        |   |   |                        |
|     proposal   |     |   |   |        |        |   |   |                        |
|     is not     |     |   |   |        |        |   |   |                        |
|     received   |     |   |   |        |        |   |   |                        |
|     by the     |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|    Contracting |     |   |   |        |        |   |   |                        |
|     Officer or |     |   |   |        |        |   |   |                        |
|     Designee   |     |   |   |        |        |   |   |                        |
|     at the     |     |   |   |        |        |   |   |                        |
|     place and  |     |   |   |        |        |   |   |                        |
|     time       |     |   |   |        |        |   |   |                        |
|     specified, |     |   |   |        |        |   |   |                        |
|     then it    |     |   |   |        |        |   |   |                        |
|     will be    |     |   |   |        |        |   |   |                        |
|     considered |     |   |   |        |        |   |   |                        |
|     late and   |     |   |   |        |        |   |   |                        |
|     handled in |     |   |   |        |        |   |   |                        |
|     accordance |     |   |   |        |        |   |   |                        |
|     with HHSAR |     |   |   |        |        |   |   |                        |
|     352.215-70 |     |   |   |        |        |   |   |                        |
|     entitled   |     |   |   |        |        |   |   |                        |
|     \"Late     |     |   |   |        |        |   |   |                        |
|     Proposals  |     |   |   |        |        |   |   |                        |
|     and        |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|    Revisions\" |     |   |   |        |        |   |   |                        |
|     located in |     |   |   |        |        |   |   |                        |
|     this       |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|  Solicitation. |     |   |   |        |        |   |   |                        |
|     FACSIMILE  |     |   |   |        |        |   |   |                        |
|     SUBMISSION |     |   |   |        |        |   |   |                        |
|     OF         |     |   |   |        |        |   |   |                        |
|     PROPOSALS  |     |   |   |        |        |   |   |                        |
|     IS NOT     |     |   |   |        |        |   |   |                        |
|                |     |   |   |        |        |   |   |                        |
|    ACCEPTABLE. |     |   |   |        |        |   |   |                        |
+----------------+-----+---+---+--------+--------+---+---+------------------------+

DETAILED TABLE OF RFP CONTENTS

[PART I - THE
SCHEDULE...............................................................................................................
4](#__RefHeading___Toc124312121)

[SECTION B - SUPPLIES OR SERVICES AND
PRICES/COSTS.........................................................
5](#__RefHeading___Toc124312122)

[ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR
SERVICES..............................................
5](#__RefHeading___Toc124312123)

[ARTICLE B.2.
PRICES/COSTS................................................................................................
5](#__RefHeading___Toc124312124)

[ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT
COSTS.....................................................
5](#__RefHeading___Toc124312125)

[ARTICLE B.4. ADVANCE
UNDERSTANDINGS...........................................................................
5](#__RefHeading___Toc124312126)

[SECTION C - DESCRIPTION/SPECIFICATIONS/WORK
STATEMENT............................................. .
5](#__RefHeading___Toc124312127)

[ARTICLE C.1. STATEMENT OF
WORK......................................................................................
5](#__RefHeading___Toc124312128)

[ARTICLE C.2. REPORTING REQUIREMENTS AND
DELIIVERABLES.............................................
6](#__RefHeading___Toc124312129)

[SECTION D - PACKAGING, MARKING AND
SHIPPING..................................................................\...
13](#__RefHeading___Toc124312130)

[SECTION E - INSPECTION AND
ACCEPTANCE.............................................................................
13](#__RefHeading___Toc124312131)

[SECTION F - DELIVERIES OR
PERFORMANCE............................................................................
. 14](#__RefHeading___Toc124312132)

[ARTICLE F.1. PERIOD OF
PERFORMANCE..................................................................](#__RefHeading___Toc124312133).........
12

[ARTICLE F.2.
DELIVERIES.....................................................................................................
14](#__RefHeading___Toc124312134)

[ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY
1998)....................................................................................................................................
18](#__RefHeading___Toc124312135)

[SECTION G - CONTRACT ADMINISTRATION
DATA........................................................................
18](#__RefHeading___Toc124312136)

[ARTICLE G.1. PROJECT
OFFICER...........................................................................................
18](#__RefHeading___Toc124312137)

[ARTICLE G.2. KEY
PERSONNEL..........................................................................................\...
19](#__RefHeading___Toc124312138)

[ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING
REQUEST.....................................
19](#__RefHeading___Toc124312139)

[ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
FINANCIAL
REPORT..............................................................................................................
20](#__RefHeading___Toc124312140)

[ARTICLE G.5. LETTER OF CREDIT PAYMENT
INFORMATION.....................................................
20](#__RefHeading___Toc124312141)

[ARTICLE G.6. CONTRACT FINANCIAL
REPORT........................................................................
21](#__RefHeading___Toc124312142)

[ARTICLE G.7. INDIRECT COST
RATES....................................................................................
22](#__RefHeading___Toc124312143)

[ARTICLE G.8. GOVERNMENT
PROPERTY................................................................................
23](#__RefHeading___Toc124312144)

[ARTICLE G.9. POST AWARD EVALUATION OF CONTRACTOR
PERFORMANCE............................
23](#__RefHeading___Toc124312145)

[SECTION H - SPECIAL CONTRACT
REQUIREMENTS....................................................................
24](#__RefHeading___Toc124312146)

[ARTICLE H.1. HUMAN
SUBJECTS............................................................................................
24](#__RefHeading___Toc124312147)

[ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH
PARTICIPANTS.......................................................................................................................
24](#__RefHeading___Toc124312148)

[ARTICLE H.3. DATA AND SAFETY MONITORING IN CLINICAL
TRIALS...........................................
22](#__RefHeading___Toc124312149)

[ARTICLE H.4. HUMAN MATERIALS (ASSURANCE OF OHRP
COMPLIANCE...................................
25](#__RefHeading___Toc124312150)

[ARTICLE H.5. HUMAN EMBRYONIC GERM CELL (HEGC) RESEARCH
.........................................
22](#__RefHeading___Toc124312151)

[ARTICLE H.6. HUMAN EMBRYONIC STEM CELL
RESEARCH..........................................\...\...\...\...
23](#__RefHeading___Toc124312152)

[ARTICLE H.7 CONTINUED BAN ON FUNDING OF HUMAN EMBRYO
RESEARCH........................ 26](#__RefHeading___Toc124312152)

[ARTICLE H.8. NEEDLE
EXCHANGE.........................................................................................
26](#__RefHeading___Toc124312153)

[ARTICLE H.9. PRIVACY ACT.............................................
....................................................
26](#__RefHeading___Toc124312154)

[ARTICLE H.10 ANIMAL
WELFARE...........................................................................................
26](#__RefHeading___Toc124312155)

[ARTICLE H.11. INTRODUCTION OF RODENTS AND RODENT
PRODUCTS....................................
26](#__RefHeading___Toc124312156)

[ARTICLE H.12. RESEARCH INVOLVING HUMAN FETAL
TISSUE............................................. ...
27](#__RefHeading___Toc124312157)

[ARTICLE H.13. OPTION PROVISION
......................................................................................
27](#__RefHeading___Toc124312158)

[ARTICLE H.14. SUBCONTRACTING
PROVISIONS.....................................................................
27](#__RefHeading___Toc124312159)

[ARTICLE H.15. SALARY RATE LIMITATION LEGISLATION
PROVISIONS.......................................
28](#__RefHeading___Toc124312160)

[ARTICLE H.16. INFORMATION
SECURITY.................................................................................
29](#__RefHeading___Toc124312161)

[ARTICLE H.17. ENERGY STAR
REQUIREMENTS.....................................................................\...
33](#__RefHeading___Toc124312162)

[ARTICLE H.18. PUBLICATION AND
PUBLICITY...........................................................................
33](#__RefHeading___Toc124312163)

[ARTICLE H.19. PRESS
RELEASES...........................................................................................
33](#__RefHeading___Toc124312164)

[ARTICLE H.20. REPORTING MATTERS INVOLVING FRAUD, WASTE AND
ABUSE........................... 34](#__RefHeading___Toc124312165)

[ARTICLE H.21. YEAR 2000
COMPLIANCE..................................................................................
34](#refheading___toc124312166)

[ARTICLE H.22. ANTI
--LOBBYING.............................................................................................
35](#__RefHeading___Toc124312167)

[ARTICLE H.23. LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION
OF CONTROLLED
SUBSTANCES..................................................................................................
36](#__RefHeading___Toc124312168)

[ARTICLE H.24. SHARING RESEARCH
DATA................................................
............................ 36](#__RefHeading___Toc124312169)

[ARTICLE H.25. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS
OR
TOXINS.................................................................................................................................
36](#__RefHeading___Toc124312170)

[ARTICLE H.26. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L.
101-391)............................. 36](#h26HOTEL)

[ARTICLE H.27. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST
ACTITIVITIES........................................................................................................................
36](#__RefHeading___Toc124312170)

[ARTICLE H.28 NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED
PUBLICATIONS RESULTING FROM NIH-FUNDED
RESEARCH............................................................................
38](#__RefHeading___Toc124312171)

[ARTICLE H.29. CONSTITUTION
DAY........................................................................................
38](#__RefHeading___Toc124312172)

ARTICLE H.30. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH
RESOURCES[............](#H30biomedresources) 35

[PART II - CONTRACT
CLAUSES...................................................................................................\...
38](#__RefHeading___Toc124312173)

[SECTION I - CONTRACT
CLAUSES...........................................................................................\...
38](#__RefHeading___Toc124312174)

[ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF
CLAUSES......................................................\...
38](#__RefHeading___Toc124312175)

[ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL
TEXT........................... 40](#__RefHeading___Toc124312176)

[PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER
ATTACHMENTS...........................................
42](#__RefHeading___Toc124312177)

[SECTION J - LIST OF
ATTACHMENTS.......................................................................................\....
42](#__RefHeading___Toc124312178)

[PART IV - REPRESENTATIONS AND
INSTRUCTIONS........................................................................
46](#__RefHeading___Toc124312179)

[SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF
OFFERORS...............................................................................................................................
46](#__RefHeading___Toc124312180)

[SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO
OFFERORS......................................
47](#__RefHeading___Toc124312181)

1\. General
Information[.........................................................................................................](#lGENERALINFO)
42

2\. Instructions to
Offerors[............................................................................................](#LINSTRUCTIONSTOOFFERORS)\...\...\.....
48

> a\. General
> Instructions[................................................................................................](#LINSTRUCTIONSTOOFFERORS)....
> 48
>
> b\. Technical Proposal
> Instructions............\...[..................................................................](#LTECHPROPOSAL)......
> 63
>
> c\. Business Proposal
> Instructions[......\...\...\...\.........................................................](#LBUSPROPOSAL)\....
> 80
>
> [SECTION M - EVALUATION FACTORS FOR AWARD
> ..................................................................
> 92](#__RefHeading___Toc124312182) 1.
> General[.......................................................................................................................](#mgeneral)
> 92

2\. Human Subject
Evaluation[...............................................................................................](#mhumansubjects)
92

3\. Evaluation of
Options[....................................................................................................](#moptions)...
95

4\. Evaluation of Data Sharing
Plan[........................................................................................](#mdatasharing)
96

5\. Evaluation of Model Sharing
Plan[.......................................................................................](#evalmodelsharing)
96

6\. Technical Evaluation
Criteria[.............................................
............................................... 96](#mtechevalcriteria)

6\. Past Performance
Factor[................................................................................................](#mpastperformance).
.99

7\. Extent of Small Disadvantaged Business
Participation[..........................................................](#msdb).
100

SOLICITATION ATTACHMENTS INCLUDED IN THIS
RFP[..................................................................](#attachmentstoRFP)
100

[]{#__RefHeading___Toc124312121 .anchor}PART I - THE SCHEDULE

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN,
CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS
**NOT** AN EXACT REPRESENTATION OF THE PROPOSED CONTRACT DOCUMENT.
CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (I.E., THOSE RELATING TO
THE ORGANIZATIONAL STRUCTURE \[E.G., NON-PROFIT, COMMERCIAL\] AND
SPECIFIC COST AUTHORIZATIONS UNIQUE TO THE OFFEROR\'S PROPOSAL AND
REQUIRING CONTRACTING OFFICER PRIOR APPROVAL) WILL BE DISCUSSED IN THE
NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT.
HOWEVER, THE ENCLOSED CONTRACT SCHEDULE PROVIDES ALL THE NECESSARY
INFORMATION FOR THE OFFEROR TO UNDERSTAND THE TERMS AND CONDITIONS OF
THE RESULTANT CONTRACT.

[]{#__RefHeading___Toc124312122 .anchor}SECTION B - SUPPLIES OR SERVICES
AND PRICES/COSTS

[]{#__RefHeading___Toc124312123 .anchor}ARTICLE B.1. BRIEF DESCRIPTION
OF SUPPLIES OR SERVICES

The purpose of this effort is to recompete the "Collaborative Network
for Clinical Research on Immune Tolerance," an international
collaborative research effort coordinating clinical testing of new
therapies to induce immune tolerance and improve treatments of
autoimmune diseases, transplantation and allergies. The Collaborative
Network on Immune Tolerance hereafter called, "The Network "was first
awarded in 1999. The scope of work to be performed by the Network
includes: 1) The design and conduct of Phase I-IV clinical trials of
investigational approaches intended to lead to a functional state of
immune tolerance; 2) The design and conduct of mechanistic studies and
the development of tolerance assays as integral components of these
clinical trials;

3\) Focused product development and nonclinical studies (e.g.,
toxicology, pharmacology, and pharmacokinetics, etc.) essential for the
subsequent evaluation of experimental tolerance induction therapies in
humans; and 4) the provision of bioinformatics, data management and
analysis resources.

For this initiative, tolerance is broadly defined as specific lack of an
immune response to targeted antigens (e.g. alloantigens, autoantigens,
or allergens) by any of a variety of approaches including deletion,
induction of anergy, immune deviation, sequestration, or suppression.
Approaches may target antigen specific receptors, molecules of the
co-stimulation pathways, homing molecules, or other relevant approaches;
and may use any of a variety of agents including antigen, peptides,
altered peptides, monoclonal antibody blockade, cytokines, molecularly
engineered cells or tissues, DNA vectors, or other relevant molecules.

[]{#__RefHeading___Toc124312124 .anchor}ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by
the Government and the Offeror. Options shall be priced separately.

[]{#__RefHeading___Toc124312125 .anchor}ARTICLE B.3. PROVISIONS
APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless
otherwise approved by the Contracting Officer. The following is a list
of items that may be included in the resultant contract as
applicable. 1) Acquisition, by purchase or lease, of any interest in
real property; 2) Special rearrangement or alteration of facilities; 3)
Purchase or lease of [any]{.underline} item of general purpose office
furniture or office equipment regardless of dollar value; 4) Travel
Costs; 5) Consultant Costs; 6) Subcontract Costs; 7) Patient Care Costs;
8) Accountable Government Property; and 9) Research Funding.

[]{#__RefHeading___Toc124312126 .anchor}ARTICLE B.4. ADVANCE
UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval
of the Contracting Officer before incurrence of the cost (e.g., foreign
travel, consultant fees, subcontracts) will be included in this Article
if the Contracting Officer has granted his/her approval prior to
contract award.

[]{#__RefHeading___Toc124312127 .anchor}SECTION C -
DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

[]{#__RefHeading___Toc124312128 .anchor}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, dated
January 30, 2006, attached hereto and made a part of this Solicitation
(See Section J - List of Attachments).

[]{#__RefHeading___Toc124312129 .anchor}ARTICLE C.2. REPORTING
REQUIREMENTS AND DELIVERABLES

**A. [Technical Progress Reports]{.underline}**

> In addition to the required reports set forth elsewhere in this
> Schedule, the preparation and submission of regularly recurring
> Technical Progress Reports will be required in any contract resulting
> from this solicitation. These reports will require descriptive
> information about the activities undertaken during the reporting
> period and will require information about planned activities for
> future reporting periods. The frequency and specific content of these
> reports will be determined prior to contract award.
>
> For proposal preparation purposes only, it is estimated that 3 copies
> of these reports will be required as follows:
>
> \(X\) Quarterly
>
> \(X\) Annually
>
> \(X\) Final -- Within 60 days prior to the expiration date of the
> contract
>
> The requirements for the reports are described below:
>
> **1. Quarterly Progress Report**
>
> The Contractor shall submit a Quarterly Progress Report within thirty
> (30) days of the close of each quarter. The first reporting period
> consists of the first full three (3) calendar months of performance
> plus any fractional part of the initial month. This report shall
> include a description of the activities during the reporting period,
> and the activities planned for the ensuing reporting period. A
> Quarterly Progress Report shall not be submitted when an Annual
> Progress Report is due. Quarterly Progress Reports shall not exceed
> twenty (20) pages and shall include the following:

a.  Face page to include the contract number, contract title,
    performance period covered, Contractor's name and address, telephone
    number, fax number, email address, and submission date.

b.  4-6 page Executive Summary to include: a brief overview of the work
    completed and major accomplishments during the reporting period.

c.  Progress Report, to include a description of the following for each
    reporting period:

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i.  The work performed and accomplishments achieved, including status of
    clinical trials and mechanistic studies (including those in
    development, active, on regulatory clinical hold, or completed);

ii. Technical, logistical, or financial problems encountered and how
    they were resolved;

iii. Lists of the clinical study final reports submitted within the
     quarter. Formats of the reports to be compliant with ICH E6
     guidelines.

iv. A list, description, and status report regarding all reagents
    produced or in production;

v.  A list, description, and status report regarding all nonclinical
    studies conducted;

vi. A list and description of laboratory facilities established;

vii. A list, description and justification of all subcontracts
     established or terminated;

viii. A list and brief description of all substantive partnerships
      involving industry, government-funded clinical research programs,
      or foundations. The description must outline the goals of the
      partnership, obligations of the individual partners, and progress
      in meeting the major objectives;

ix. A discussion of progress on the development and operations of
    bioinformatics activities; and

x.  Key personnel changes.

xi. Copies of manuscripts and abstracts published or submitted for
    publication completed for each quarter.

xii. A full disclosure of any inventions and patent or copyright
     applications submitted or in development.

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2.  **Annual Progress Report**

> The Contractor shall submit an Annual Progress Report thirty (30) days
> after the close of each annual performance period. This report shall
> include a summation of the results of the entire contract work for the
> period covered. An Annual Report shall not be required for the period
> when the Final Report is due. Annual Progress reports shall not exceed
> one hundred (100) pages and shall include the following for each
> performance period:

a.  Face page to include the contract number, contract title,
    performance period covered, Contractor's name and address, telephone
    number, fax number, email address, and submission date.

> 4-6 page Executive Summary to include: a brief overview of the work
> completed, and major accomplishments.

b.  A description of:

    i.  The work performed and accomplishments achieved, including
        status of clinical trials and mechanistic studies (including
        those in development, active, on regulatory clinical hold, or
        completed);

    ii. Technical, logistical, or financial problems encountered and how
        they were resolved;

    iii. A list, description, and status report regarding all reagents
         produced or in production;

    iv. A list, description, and status report regarding all nonclinical
        studies completed, ongoing or in development;

    v.  A list, description and status of Final Study Reports for trials
        completed during the reporting period;

    vi. A list, description and justification of laboratory facilities
        established and current measures of quality assurance and
        quality control measures;

    vii. A list, description and status report of tolerance assays
         established or under development;

    viii. A list and description of standard operating procedures for
          the conduct of mechanistic studies;

    ix. A list and justification of all subcontracts established or
        terminated;

    x.  Key personnel changes;

    xi. A list and brief description of all substantive partnerships
        involving industry, government-funded clinical research
        programs, or foundations. The description must outline the goals
        of the partnership, obligations of the individual partners, and
        progress in meeting the major objectives;

    xii. Documentation of bioinformatics system and software
         requirements and progress. Requirements updates shall address
         all issues that may arise due to modified or newly discovered
         requirements, as well as software lifecycle issues. This
         section of the report shall also explain the benefits delivered
         by the system of databases and technical support work, discuss
         any barriers to implementation and how they have been
         addressed, discuss the current and needed functions of the
         platform based on a thorough understanding of end-user
         requirements, and include the annual Automated Information
         System Security Report; and

    xiii. Documentation of computer and data system security. The
          documentation shall include:

          a.  A log or record of the results from testing the Continuity
              of Operations Plan (COOP), any existing plans and progress
              reports for implementing additional security safeguards
              and controls; and the system access authorization list.
              The profile shall be kept up-to-date for review and
              potential inspection upon demand by NIH/DHHS authorized
              agents. Upon request, copies of specified profile
              documents shall be presented to NIH/DHHS for its own
              system\'s security reporting purposes.

          b.  System Security Plan. The preparation of the System
              Security Plan shall follow the instructions in OMB
              Bulletin 90-08
              (<http://irm.cit.nih.gov/itmra/omb90-08.html>).

          c.  Describe revisions or proposed revisions to the Network
              Strategic Plan and Research Agenda.

    xiv. Update of the scientific administration plan, including the
         plans and rationale for the redirection of Network resources.

    xv. Summary of Network progress toward identification of biomarkers
        of the induction, maintenance, and loss of tolerance.

    xvi. List of Final Study Reports and Quarterly Progress Reports for
         the entire reporting period and as well as manuscripts and
         abstracts published or submitted for publication.

    xvii. A status report on all clinical trials summarizing adherence
          to, and deviations from, projected timelines for protocol
          development, implementation, and completion. The report must
          outline steps taken, or to be taken, in the next quarterly
          reporting period to address significant deviations.

    xviii. A financial status report summarizing invoiced expenditures
           and the Contractor's best estimates of actual costs incurred
           (invoiced plus those to be invoiced) and projected future
           costs. The report must detail the relevant expenditures and
           projected expenditures for each clinical trial and
           mechanistic study, and those costs and cost projections for
           individual mechanistic laboratory facilities, taking into
           account deviations from projected timelines for completion of
           studies.

    xix. Full disclosure of any inventions, and patent or copyright
         applications submitted or in development.

    xx. A report summarizing the Network's reporting and management of
        Conflict of Interest. At a minimum, the report must provide
        anonymous summary data regarding real and potential conflicts of
        interest and the steps taken to address these issues.

> **3. Annual Progress Report for Clinical Research Study Populations**
>
> The Contractor shall submit information about the inclusion of women
> and members of minority groups and their subpopulations for each study
> being performed under this contract. The contractor shall submit this
> information in the format indicated in the attachment entitled,
> \"Inclusion Enrollment Report,\" which is set forth in Section J of
> the contract. The contractor also shall use this format, modified to
> indicate that it is a final report, for reporting purposes in the
> final report. The contractor shall submit the report in accordance
> with ARTICLE F.1. DELIVERABLES of the contract. In addition, the NIH
> Policy and Guidelines on the Inclusion of Women and Minorities as
> Subjects in Clinical Research, Amended, October 2001 applies. As the
> Statement of Work includes conduct of Phase III clinical trials, see
> II.B of these guidelines. The Guidelines may be found at the following
> website: ().
>
> Include a description of the plans to conduct analyses, as
> appropriate, by gender and/or racial/ethnic groups in the clinical
> trial protocols as approved by the IRB, and provide a description of
> the progress in the conduct of these analyses, as appropriate, in the
> annual progress report and in the final report. If the analysis
> reveals no subset differences, a brief statement to that effect,
> indicating the subsets analyzed, will suffice. The Government strongly
> encourages inclusion of the results of subset analyses in all
> publication submissions. In the final report, the Contractor shall
> include all final analyses of the data on gender and race/ethnicity.
>
> **4. Final Report**
>
> The Final Report shall consist of a description of the work performed
> and results obtained for the entire contract period of performance as
> stated in Section F of this contract. This report shall be in
> sufficient detail to describe comprehensively the results achieved.
> The Final Report shall be submitted sixty (60) calendar days prior to
> the contract performance end date. The Final Report shall include the
> following;

a.  Face page to include the contract number, contract title,
    performance period covered, Contractor's name and address, telephone
    number, fax number, email address, and submission date.

b.  Introduction covering the purpose and scope of the contract effort
    including a summary of the major accomplishments (not to exceed 500
    words) during performance of the contract.

c.  An Executive Summary to include fulfillment of the contract goals
    and specific activities set forth in the Statement of Work.
    Executive Summary should not exceed 25 pages.

d.  A detailed description of the work performed (as described for the
    Annual Reports), the results obtained, and the impact and
    implications of the results on the scientific community and the
    public health of the Nation.

e.  A list of all manuscripts published and in preparation and abstracts
    presenting work performed under the contract.

f.  A report outlining the status of all partnerships with industry,
    Government-funded clinical research programs, and foundations.

g.  List of all Government-furnished property, including reagents that
    could be made available to the successor contractor or returned to
    the Government.

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5.  **Summary of Salient Results**

> The Contractor shall be required to prepare and submit, with the Final
> Report, a summary (not to exceed 200 words) of salient results
> achieved during the performance of the contract. This report shall be
> required 60 days before the contract completion date.

**C. [Other Reports/Deliverables]{.underline}**

1.  **Human Subjects IRB Annual Report** (Formerly form 310, currently
    OMB 0990-0263 or other)

2.  **Invention Report Requirement -**

All reports and documentation required by FAR Clause 52.227-11
including, but not limited to, the invention disclosure report, the
confirmatory license, and the government support certification, shall be
directed to the Office of Extramural Inventions and Technology Resources
Branch, OPERA, NIH, 6705 Rockledge Drive, Room 1040 A, MSC 7980,
Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition,
one copy of an annual utilization report, and a copy of the final
invention statement, shall be submitted to the Contracting Officer. The
final invention statement (see FAR 27.303(a)(2)(ii)) shall be submitted
on the expiration date of the contract to the Contracting Officer.

The final invention statement (see FAR 27.303(a)(2)(ii)) shall be
submitted on the expiration date of the contract to the following
address:

Contracting Officer

Office of Acquisitions

DEA, NIAID, NIH, DHHS

6700-B Rockledge Drive, Room 3214, MSC 7612

Bethesda, Maryland 20892-7612

(Express Mail: Bethesda, MD 20817)

If no invention is disclosed or no activity has occurred on a previously
disclosed invention during the applicable reporting period, a negative
report shall be submitted to the Contracting Officer at the address
listed above.

To assist contractors in complying with invention reporting requirements
of the clause, the NIH has developed \"Interagency Edison,\" an
electronic invention reporting system. Use of Interagency Edison is
encouraged as it streamlines the reporting process and greatly reduces
paperwork. Access to the system is through a secure interactive Web site
to ensure that all information submitted is protected. Interagency
Edison and information relating to the capabilities of the system can be
obtained from the Web
([[http://www.iedison.gov]{.underline}](http://www.iedison.gov/)), or by
contacting the Office of Extramural Inventions and Technology Resources
Branch, OPERA, NIH.

3.  **Source Code and Object Code -** Unless otherwise specified herein,
    the Contractor shall deliver to the Government, upon the expiration
    date of the contract, all source code and object code developed,
    modified, and/or enhanced under this contract.

4.  **Industry Liaison -** Within two months of the award of the
    contract, the Contractor shall submit to the NIAID Project Officer a
    plan to identify and capitalize on opportunities for industry
    partnerships to accomplish the goals and objectives described in the
    Network Research Agenda for review and approval.

5.  **Strategic Plan and Research Agenda-** Within two months of the
    award of the contract, the Contractor shall submit to the NIAID
    Project Officer a final Strategic Plan and Research Agenda
    addressing the requirements outlined in the Statement of Work for
    review and approval.

6.  **Network Executive and Steering Committees -** Within 120 days
    after award, the Network Executive Committee shall submit to the
    NIAID Project Officer recommendations of appointees to the Executive
    and Protocol Review Committees. In addition, the Network Executive
    Committee shall submit final proposed Network bylaws, policies, and
    standard operating procedures for all aspects of Network activities
    to the NIAID Project Officer for review and approval.

7.  **Nonclinical Research and Product Development Final Study Reports**

    a.  The Contractor must prepare and submit Final Study Reports for
        the nonclinical studies (e.g., pharmacokinetics, metabolism and
        toxicology studies) conducted in support of the proposed
        clinical trials, to the NIAID Project Officer or designee in
        formats compliant with the International Conference on
        Harmonization (ICH) guidelines (see
        [www.fda.gov](http://www.fda.gov/)). Health Authority
        submission. These reports must be submitted within ninety (90)
        days after study completion.

    b.  Provide to the NIAID Project Officer or designee documents
        concerning manufacture, release testing, and stability testing
        of drug substance and drug product in formats compliant with for
        FDA cGMP requirements. These documents must be submitted within
        ninety (90) days after completion of testing.

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8.  **Clinical Research**

    a.  Provide to the NIAID Project Officer or designee, revised
        Clinical Trial Protocols addressing comments and requirements of
        the NIAID DAIT Clinical Research Committee, NIAID Data Safety
        Monitory Boards (DSMBs), and the Health Authorities

    b.  Provide, in a timely manner, miscellaneous reports as required
        by the NIAID Project Officer, NIAID Regulatory Staff, and NIAID
        Medical Monitors to address regulatory and other project
        management requirements.

9.  **Bioinformatics, Data Collection, and Validation**

    a.  Two (2) months after contract award and every three (3) years
        thereafter, the Contractor shall provide documentation of a Risk
        Analysis Assessment following the guidance given in NIH Security
        Plan Template
        (<http://irm.cit.nih.gov/security/secplantemp.doc>). The Risk
        Analysis Assessment is to be maintained and updated every three
        years, or in advance of implementing major system modifications
        or enhancements.

    b.  Two (2) months after contract award, the Contractor shall
        develop and submit a Continuity of Operations Plan (COOP)
        following the guidance in NIH Security Plan Template
        (<http://irm.cit.nih.gov/security/secplantemp.doc>). At a
        minimum, the COOP shall cover emergency operations, backup
        operations, and recovery plans to assure continuous operations
        of the system's facility. COOP testing shall be conducted and
        results recorded at least every six (6) months.

    c.  Twelve (12) months after contract award, and every twelve (12)
        months thereafter, the Contractor shall provide a demonstration,
        to the NIAID Project Officer or his designee, of a fully
        operable system of databases including interfaces for data
        acquisition, data models, and ontologies or structured
        vocabularies, as well as initial documentation for all hardware
        and software. The contractor shall regularly update and refine
        these deliverables in accordance with end user requirements.
        These modifications and appropriate measures of their impact
        shall be reported in the Annual Progress Report to the NIAID
        Project Officer.

    d.  Six (6) months after contract award, develop and implement a
        long-range plan for the long-term maintenance and survival of
        the data and data system.

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10. **Plan for Selection, Development and Validation of Assays and
    Laboratories**

> Within three (3) months after contract award, the Contractor shall
> provide a process for the selection of laboratories and the
> development and validation of assays.

11. **Plan for Collaborations with Clinical Research Programs and
    Organizations**

    a.  Within six (6) months after contract award, the Contractor shall
        provide a plan to establish and maintain collaborations with
        government- or privately-sponsored research networks and with
        the pharmaceutical and biotechnology industries.

    b.  Within six (6) months of contract award, and annually
        thereafter, the Contractor shall provide a summary of current
        collaborations and plans for future collaborations with other
        clinical research programs and organizations.

> **12. Final Clinical Study Reports**
>
> a\. Prepare and submit to the NIAID Project Officer or designee Final
> Clinical Study Reports for each completed clinical trial within six
> (6) months of the database freeze. The individual Final Clinical Study
> Reports may be a component of suitably timed Quarterly Progress
> Reports or Annual Progress Reports.
>
> **13. Initial and Final Transition Plans**

a.  Submit an Initial Transition Plan six (6) weeks after award of the
    contract.

b.  Submit a Final Transition Plan six (6) months prior to the
    completion date of the contract.

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14. **Software and Data**

> The contractor shall deliver to the Government, upon the expiration
> date of the contract, all software and data developed, modified,
> and/or enhanced under this contract.
>
> SECTION D - PACKAGING, MARKING AND SHIPPING

[]{#__RefHeading___Toc124312130 .anchor}SECTION D - PACKAGING, MARKING
AND SHIPPING

All deliverables required under this contract shall be packaged, marked
and shipped in accordance with Government specifications. At a minimum,
all deliverables shall be marked with the contract number and contractor
name. The Contractor shall guarantee that all required materials shall
be delivered in immediate usable and acceptable condition.

[]{#__RefHeading___Toc124312131 .anchor}SECTION E - INSPECTION AND
ACCEPTANCE

a\. The Contracting Officer or the duly authorized representative will
perform inspection and acceptance of materials and services to be
provided.

b\. For the purpose of this SECTION, (to be specified before award) the
authorized representative of the Contracting Officer.

c\. Inspection and acceptance will be performed at 6610 Rockledge Drive,
Bethesda, MD.

> Acceptance may be presumed unless otherwise indicated in writing by
> the Contracting Officer or the duly authorized representative within
> 30 days of receipt.

d\. This contract incorporates the following clause by reference, with
the same force and effect as if it were given in full text. Upon
request, the Contracting Officer will make its full text available.

FAR Clause **52.246-9, Inspection of Research and Development (Short
Form)** (April 1984).

[]{#__RefHeading___Toc124312132 .anchor}SECTION F - DELIVERIES OR
PERFORMANCE

[]{#__RefHeading___Toc124312133 .anchor}ARTICLE F.1. PERIOD OF
PERFORMANCE

The period of performance of this contract shall be from February 1,
2007 through January 31, 2014.

[]{#__RefHeading___Toc124312134 .anchor}ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur
upon performance of the work described in Article C.1. and upon delivery
and acceptance by the Contracting Officer, or the duly authorized
representative, of the following items in accordance with the stated
delivery schedule:

a\. The items specified below as described in [SECTION C, ARTICLE
C.2.]{.underline} will be required to be delivered F.O.B. Destination as
set forth in FAR Clause 52.247-35, F.O.B. Destination, Within Consignees
Premises (April 1984), and in accordance with and by the date(s)
specified below and any specifications stated in [SECTION D, PACKAGING,
MARKING AND SHIPPING]{.underline}, of the contract.

b\. Technical Reports Delivery and Distribution Schedule:

+-----+------------+-----------+------------+------------------------+
| **  | ### **T    | ###       | ### **Reci | ### **Su               |
| Ite | ype of Del | **Initial | pients &** | bsequent Reports Due** |
| m** | iverable** |  Report** |            |                        |
|     |            |           | ###        |                        |
|     |            | **Due**   | **Number o |                        |
|     |            |           | f Copies** |                        |
+-----+------------+-----------+------------+------------------------+
| 1\. | Quarterly  | 30 days   | 3 Copies   | Quarterly; due on or   |
|     | Progress   | following | to PO (1   | before 30 days         |
|     | Report to  | c         | copy to be | following the end of   |
|     | include    | ompletion | sent       |                        |
|     | clinical,  | of the    | elect      | each 3 month period    |
|     | bioi       | first     | ronically) | beginning with the     |
|     | nformatics | three     |            | start of the contract. |
|     | and        | full      | 2 Copies   |                        |
|     | m          | Calendar  | to CO      | Quarterly report will  |
|     | echanistic | Months of |            | not be due when an     |
|     | studies    | the       | (1 copy to | annual or final report |
|     |            | Contract  | be sent    | is due.                |
|     |            |           | elect      |                        |
|     |            |           | ronically) |                        |
+-----+------------+-----------+------------+------------------------+
| 2\. | Annual     | 30 days   | 3 Copies   | Annually; submitted 30 |
|     | Progress   | following | to PO (1   | days after the         |
|     | Report     | the       | copy to be | anniversary date. An   |
|     |            | An        | sent       | annual report is not   |
|     |            | niversary | elect      | due when a final       |
|     |            | Date of   | ronically) | report is due.         |
|     |            | Contract  |            |                        |
|     |            |           | 2 Copies   |                        |
|     |            |           | to CO      |                        |
|     |            |           |            |                        |
|     |            |           | (1 copy to |                        |
|     |            |           | be sent    |                        |
|     |            |           | elect      |                        |
|     |            |           | ronically) |                        |
+-----+------------+-----------+------------+------------------------+
| 3\. | Annual     | 30 days   | 3 Copies   | Annually; submitted 30 |
|     | Progress   | following | to PO (1   | days after the         |
|     | Report for | the       | copy to be | anniversary date.      |
|     | Clinical   | An        | sent       |                        |
|     | Research   | niversary | elect      |                        |
|     | Study      | Date of   | ronically) |                        |
|     | P          | Contract  |            |                        |
|     | opulations |           | 1 Copy to  |                        |
|     |            |           | CO         |                        |
|     |            |           |            |                        |
|     |            |           | (copy to   |                        |
|     |            |           | be sent    |                        |
|     |            |           | elect      |                        |
|     |            |           | ronically) |                        |
+-----+------------+-----------+------------+------------------------+
| **  | ### **T    | ###       | ### **Reci | ### **Su               |
| Ite | ype of Del | **Initial | pients &** | bsequent Reports Due** |
| m** | iverable** |  Report** |            |                        |
|     |            |           | ###        |                        |
|     |            | **Due**   | **Number o |                        |
|     |            |           | f Copies** |                        |
+-----+------------+-----------+------------+------------------------+
| 4\. | Final      | 60 days   | 3 Copies   | N/A                    |
|     | Report     | prior to  | to PO ( 1  |                        |
|     |            | the       | copy to be |                        |
|     | To include | e         | sent       |                        |
|     | a summary  | xpiration | elect      |                        |
|     | of salient | date of   | ronically) |                        |
|     | results    | the       |            |                        |
|     |            | contract  | 2 Copies   |                        |
|     |            |           | to CO      |                        |
|     |            |           |            |                        |
|     |            |           | (1 copy to |                        |
|     |            |           | be sent    |                        |
|     |            |           | elect      |                        |
|     |            |           | ronically) |                        |
+-----+------------+-----------+------------+------------------------+

c\. Other Reports Delivery Schedule

+-------+-----------+---------+-----------+--------------+---+-----------+
| **I   | ### **Typ | ### **S | ###       | ### **Re     | # |           |
| tem** | e of Deli | OW Refe | **Initial | cipients &** | # |           |
|       | verable** | rence** |  Report** |              | # |           |
|       |           |         |           | ### **Number |   |           |
|       |           |         | ##        |  of Copies** | * |           |
|       |           |         | # **Due** |              | * |           |
|       |           |         |           |              | S |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | b |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | q |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              |   |           |
|       |           |         |           |              | R |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | p |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              |   |           |
|       |           |         |           |              | D |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | * |           |
|       |           |         |           |              | * |           |
+=======+===========+=========+===========+==============+===+===========+
| 1\.   | Human     |         | With      | 3 Copies to  | A |           |
|       | Subjects  |         | Ann       | PO           | n |           |
|       | IRB       |         | ual/Final |              | n |           |
|       | Annual    |         | Reports   | (1 copy to   | u |           |
|       | Review    |         |           | be sent      | a |           |
|       |           |         |           | ele          | l |           |
|       |           |         |           | ctronically) | l |           |
|       |           |         |           |              | y |           |
|       |           |         |           | 2 Copies to  | ; |           |
|       |           |         |           | CO(1 copy to | s |           |
|       |           |         |           | be sent      | u |           |
|       |           |         |           | el           | b |           |
|       |           |         |           | ectronically | m |           |
|       |           |         |           |              | i |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | d |           |
|       |           |         |           |              | 3 |           |
|       |           |         |           |              | 0 |           |
|       |           |         |           |              | d |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | y |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | f |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | h |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | i |           |
|       |           |         |           |              | v |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | y |           |
|       |           |         |           |              | d |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | . |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 2\.   | Invention |         | As        | 3 Copies to  | A |           |
|       | Report    |         | required  | PO           | s |           |
|       |           |         |           |              | r |           |
|       |           |         |           | (1 copy to   | e |           |
|       |           |         |           | be sent      | q |           |
|       |           |         |           | ele          | u |           |
|       |           |         |           | ctronically) | i |           |
|       |           |         |           |              | r |           |
|       |           |         |           | 1 Copy to CO | e |           |
|       |           |         |           |              | d |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 3\.   | Source    |         | On        | 2 Copies to  | N |           |
|       | Code and  |         | e         | PO (1 copy   | / |           |
|       | Object    |         | xpiration | to be sent   | A |           |
|       | Code      |         | date of   | elec         |   |           |
|       |           |         | contract  | tronically.) |   |           |
|       |           |         |           | CO copied on |   |           |
|       |           |         |           | transmission |   |           |
|       |           |         |           | letter.      |   |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 4\.   | Industry  |         | Within 2  | 3 Copies to  | N |           |
|       | Liaison   |         | months of | PO (1 copy   | / |           |
|       | Plan      |         | award of  | to be sent   | A |           |
|       |           |         | contract  | ele          |   |           |
|       |           |         |           | ctronically) |   |           |
|       |           |         |           |              |   |           |
|       |           |         |           | 2 Copies to  |   |           |
|       |           |         |           | CO           |   |           |
|       |           |         |           |              |   |           |
|       |           |         |           | (1 copy to   |   |           |
|       |           |         |           | be sent      |   |           |
|       |           |         |           | el           |   |           |
|       |           |         |           | ectronically |   |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 5\.   | Strategic | SOW     | Within 2  | 3 Copies to  | A |           |
|       | Plan and  | Task I  | months of | PO (1 copy   | n |           |
|       | Research  |         | award of  | to be sent   | n |           |
|       | Agenda    |         | the       | ele          | u |           |
|       |           |         | contract  | ctronically) | a |           |
|       |           |         |           |              | l |           |
|       |           |         |           | 2 Copies to  | l |           |
|       |           |         |           | CO           | y |           |
|       |           |         |           |              | , |           |
|       |           |         |           | (copy to be  | a |           |
|       |           |         |           | sent         | s |           |
|       |           |         |           | el           | a |           |
|       |           |         |           | ectronically | c |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | m |           |
|       |           |         |           |              | p |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | f |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | h |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | A |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | l |           |
|       |           |         |           |              | P |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | g |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              | R |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | p |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | t |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 6\.   | Network   | SOW     | Within    | 3 Copies to  | A |           |
|       | Executive | Task II | 120 days  | PO (1 copy   | s |           |
|       | and       |         | of award  | to be sent   | r |           |
|       | Steering  |         | of the    | ele          | e |           |
|       | Committee |         | contract  | ctronically) | q |           |
|       | M         |         |           |              | u |           |
|       | embership |         |           | 2 Copies to  | i |           |
|       |           |         |           | CO           | r |           |
|       |           |         |           |              | e |           |
|       |           |         |           | (copy to be  | d |           |
|       |           |         |           | sent         |   |           |
|       |           |         |           | el           |   |           |
|       |           |         |           | ectronically |   |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 7\.   | No        | SOW     | Within 90 | 3 Copies to  | A |           |
|       | nclinical | Task    | days of   | PO (1 copy   | s |           |
|       | Study and | III     | c         | to be sent   | r |           |
|       | Product   |         | ompletion | ele          | e |           |
|       | De        |         | of the    | ctronically) | q |           |
|       | velopment |         | study or  |              | u |           |
|       | Reports   |         | product   | 1 Copy to CO | i |           |
|       |           |         | ma        |              | r |           |
|       |           |         | nufacture |              | e |           |
|       |           |         |           |              | d |           |
|       |           |         |           |              | ; |           |
|       |           |         |           |              | W |           |
|       |           |         |           |              | i |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | h |           |
|       |           |         |           |              | i |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | 9 |           |
|       |           |         |           |              | 0 |           |
|       |           |         |           |              | d |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | y |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | f |           |
|       |           |         |           |              | c |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | m |           |
|       |           |         |           |              | p |           |
|       |           |         |           |              | l |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | i |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | f |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | h |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | d |           |
|       |           |         |           |              | y |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | p |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | d |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | c |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | m |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | f |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | c |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | e |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 8a.   | Clinical  | SOW     | As        | 3 Copies to  | A |           |
|       | Trial     | Task    | required  | PO (1 copy   | s |           |
|       | Protocols | IV,     |           | to be sent   | r |           |
|       |           | item A  |           | ele          | e |           |
|       |           |         |           | ctronically) | q |           |
|       |           |         |           |              | u |           |
|       |           |         |           | 2 Copies to  | i |           |
|       |           |         |           | CO           | r |           |
|       |           |         |           |              | e |           |
|       |           |         |           | (1 copy to   | d |           |
|       |           |         |           | be sent      |   |           |
|       |           |         |           | ele          |   |           |
|       |           |         |           | ctronically) |   |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 8b.   | Clinical  |         | As        | 3 Copies to  | A |           |
|       | Research  |         | required  | PO or        | s |           |
|       | Misc      |         |           | designee(1   | r |           |
|       | ellaneous |         |           | copy to be   | e |           |
|       | reports   |         |           | sent         | q |           |
|       |           |         |           | el           | u |           |
|       |           |         |           | ectronically | i |           |
|       |           |         |           |              | r |           |
|       |           |         |           | 1 Copy to CO | e |           |
|       |           |         |           |              | d |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 9a.   | Risk      |         | 2 months  | 2 Copies to  | E |           |
|       | Analysis  |         | after     | PO (1 copy   | v |           |
|       | A         |         | contract  | to be sent   | e |           |
|       | ssessment |         | award     | ele          | r |           |
|       |           |         |           | ctronically) | y |           |
|       |           |         |           |              | 3 |           |
|       |           |         |           | 2 Copies to  | y |           |
|       |           |         |           | CO           | e |           |
|       |           |         |           |              | a |           |
|       |           |         |           | (copy to be  | r |           |
|       |           |         |           | sent         | s |           |
|       |           |         |           | el           | a |           |
|       |           |         |           | ectronically | f |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | c |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | c |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | w |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | d |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 9b.   | C         |         | 2 months  | 2 Copies to  | T |           |
|       | ontinuity |         | after     | PO (1 copy   | e |           |
|       | of        |         | contract  | to be sent   | s |           |
|       | O         |         | award     | ele          | t |           |
|       | perations |         |           | ctronically) | r |           |
|       | Plan      |         |           |              | e |           |
|       |           |         |           | 2 Copies to  | s |           |
|       |           |         |           | CO           | u |           |
|       |           |         |           |              | l |           |
|       |           |         |           | (copy to be  | t |           |
|       |           |         |           | sent         | s |           |
|       |           |         |           | el           | d |           |
|       |           |         |           | ectronically | u |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | v |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | y |           |
|       |           |         |           |              | 6 |           |
|       |           |         |           |              | m |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | h |           |
|       |           |         |           |              | s |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 9c.   | Demo      |         | 12 months | 2 Copies of  | D |           |
|       | nstration |         | after     | d            | e |           |
|       | and       |         | contract  | ocumentation | m |           |
|       | docu      |         | award     | to PO (1     | o |           |
|       | mentation |         |           | copy to be   | n |           |
|       | to PO of  |         |           | sent         | s |           |
|       | fully     |         |           | ele          | t |           |
|       | operable  |         |           | ctronically) | r |           |
|       | system of |         |           |              | a |           |
|       | databases |         |           | 2 Copies to  | t |           |
|       |           |         |           | CO           | i |           |
|       |           |         |           |              | o |           |
|       |           |         |           | (1 copy to   | n |           |
|       |           |         |           | be sent      | a |           |
|       |           |         |           | el           | n |           |
|       |           |         |           | ectronically | d |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | p |           |
|       |           |         |           |              | d |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | f |           |
|       |           |         |           |              | d |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | c |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | m |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | i |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              |   |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | v |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | y |           |
|       |           |         |           |              | 1 |           |
|       |           |         |           |              | 2 |           |
|       |           |         |           |              | m |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | h |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              | . |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 9d.   | Long      |         | 6 months  | 2 Copies to  | N |           |
|       | Range     |         | after     | PO (1 copy   | / |           |
|       | Plan for  |         | contract  | to be sent   | A |           |
|       | Long-term |         | award     | ele          |   |           |
|       | ma        |         |           | ctronically) |   |           |
|       | intenance |         |           |              |   |           |
|       | and       |         |           | 2 Copies to  |   |           |
|       | survival  |         |           | CO           |   |           |
|       | of data   |         |           |              |   |           |
|       | and data  |         |           | (1 copy to   |   |           |
|       | system    |         |           | be sent      |   |           |
|       |           |         |           | el           |   |           |
|       |           |         |           | ectronically |   |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 10\.  | Plan for  | SOW     | Within 3  | 3 Copies to  |   | As        |
|       | S         | Task V, | months of | PO (1 copy   |   | required  |
|       | election, | item B  | contract  | to be sent   |   |           |
|       | De        |         | award     | ele          |   |           |
|       | velopment |         |           | ctronically) |   |           |
|       | and       |         |           |              |   |           |
|       | V         |         |           | 1 Copy to CO |   |           |
|       | alidation |         |           |              |   |           |
|       | of Assays |         |           |              |   |           |
|       | and       |         |           |              |   |           |
|       | Lab       |         |           |              |   |           |
|       | oratories |         |           |              |   |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 11a.  | Plan for  | SOW     | Within 2  | 3 Copies to  | A |           |
|       | Clinical  | Task    | months of | PO (1 copy   | s |           |
|       | Research  | VII     | award of  | to be sent   | r |           |
|       |           |         | the       | ele          | e |           |
|       | Colla     |         | contract  | ctronically) | q |           |
|       | borations |         |           |              | u |           |
|       |           |         |           | 1 Copy to CO | i |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | d |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 11b.  | Summary   | SOW     | 6 months  | 3 Copies to  | A |           |
|       | of        | Task    | after     | PO (1 copy   | n |           |
|       | Colla     | VII     | award of  | to be sent   | n |           |
|       | borations |         | the       | ele          | u |           |
|       |           |         | Contract  | ctronically) | a |           |
|       |           |         |           |              | l |           |
|       |           |         |           | 1 Copy to CO | l |           |
|       |           |         |           |              | y |           |
|       |           |         |           |              | , |           |
|       |           |         |           |              | m |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | y |           |
|       |           |         |           |              | b |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | b |           |
|       |           |         |           |              | m |           |
|       |           |         |           |              | i |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | d |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              | p |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | f |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | h |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | A |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | l |           |
|       |           |         |           |              | R |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | p |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | i |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | b |           |
|       |           |         |           |              | l |           |
|       |           |         |           |              | y |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | i |           |
|       |           |         |           |              | m |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | d |           |
|       |           |         |           |              | Q |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | l |           |
|       |           |         |           |              | y |           |
|       |           |         |           |              | R |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | p |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | t |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 12\.  | Final     |         | 6 months  | 4 Copies to  | A |           |
|       | Clinical  |  ------ | after     | PO           | s |           |
|       | Study     |   SOW   | databa    |              | r |           |
|       | Reports   |   Task  | se-freeze | (1 copy to   | e |           |
|       |           |   IV    |           | be sent      | q |           |
|       |           |         |           | ele          | u |           |
|       |           |         |           | ctronically) | i |           |
|       |           |  ------ |           |              | r |           |
|       |           |         |           | 1 Copy to CO | e |           |
|       |           |         |           |              | d |           |
|       |           |         |           |              | b |           |
|       |           |         |           |              | y |           |
|       |           |         |           |              | c |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | m |           |
|       |           |         |           |              | p |           |
|       |           |         |           |              | l |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | i |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | f |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | d |           |
|       |           |         |           |              | i |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              | ; |           |
|       |           |         |           |              | 6 |           |
|       |           |         |           |              | m |           |
|       |           |         |           |              | o |           |
|       |           |         |           |              | n |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | h |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | f |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | c |           |
|       |           |         |           |              | h |           |
|       |           |         |           |              | d |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | t |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | b |           |
|       |           |         |           |              | a |           |
|       |           |         |           |              | s |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | - |           |
|       |           |         |           |              | f |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | z |           |
|       |           |         |           |              | e |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 13a.  | Initial   | SOW     | 6 weeks   | 3 Copies to  | N |           |
|       | T         | Task    | after     | PO           | / |           |
|       | ransition | IX,     | award of  |              | A |           |
|       | Plan      | item A  | contract  | (1 copy to   |   |           |
|       |           |         |           | be sent      |   |           |
|       |           |         |           | ele          |   |           |
|       |           |         |           | ctronically) |   |           |
|       |           |         |           |              |   |           |
|       |           |         |           | 1 Copy to CO |   |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 13b.  | Final     | SOW     | 6 months  | 3 Copies to  | N |           |
|       | T         | Task    | prior to  | PO           | / |           |
|       | ransition | IX,     | e         |              | A |           |
|       | Plan      | item B  | xpiration | (1 copy to   |   |           |
|       |           |         | of the    | be sent      |   |           |
|       |           |         | contract  | ele          |   |           |
|       |           |         |           | ctronically) |   |           |
|       |           |         |           |              |   |           |
|       |           |         |           | 2 Copies to  |   |           |
|       |           |         |           | CO           |   |           |
|       |           |         |           |              |   |           |
|       |           |         |           | (1 copy to   |   |           |
|       |           |         |           | be sent      |   |           |
|       |           |         |           | el           |   |           |
|       |           |         |           | ectronically |   |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 14\.  | Data and  |         | On        | 3 Copies to  | N |           |
|       | Software  |         | c         | PO           | / |           |
|       |           |         | ompletion |              | A |           |
|       |           |         | of        | (1 copy to   |   |           |
|       |           |         | contract  | be sent      |   |           |
|       |           |         |           | ele          |   |           |
|       |           |         |           | ctronically) |   |           |
|       |           |         |           |              |   |           |
|       |           |         |           | 1 Copy to CO |   |           |
+-------+-----------+---------+-----------+--------------+---+-----------+
| 15\.  | Other     |         | As        | As required  | A |           |
|       | Del       |         | required. |              | s |           |
|       | iverables |         |           |              | R |           |
|       |           |         |           |              | e |           |
|       | TBD       |         |           |              | q |           |
|       |           |         |           |              | u |           |
|       |           |         |           |              | i |           |
|       |           |         |           |              | r |           |
|       |           |         |           |              | e |           |
|       |           |         |           |              | d |           |
|       |           |         |           |              | . |           |
+-------+-----------+---------+-----------+--------------+---+-----------+

Copies of reports and deliverables shall be sent to the following
addresses:

NIAID Project Officer: National Institutes of Health, DHHS

> Address: National Institute of Allergy and Infectious Diseases
>
> Division of Allergy, Immunology and Transplantation

6610 Rockledge Drive, Room 3049

> Bethesda, MD 20892
>
> NIAID Contracting Officer: National Institute of Allergy and
> Infectious Diseases
>
> Office of Acquisitions,
>
> DEA, NIAID, NIH, DHHS\
> 6700B Rockledge Drive, Room 3214,  MSC 7612\
> Bethesda, MD  20892-7612\
> (Express Mail:  Bethesda, MD  20817)

[]{#__RefHeading___Toc124312135 .anchor}ARTICLE F.3. CLAUSES
INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

This contract incorporates the following clause by reference, with the
same force and effect as if it were given in full text. Upon request,
the Contracting Officer will make its full text available. Also, the
full text of a clause may be accessed electronically at this address:
[[http://www.arnet.gov/far/]{.underline}](http://www.arnet.gov/far/).

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

> **52.242-15, Stop Work Order** (August 1989) with **Alternate I**
> (April 1984).

[]{#__RefHeading___Toc124312136 .anchor}SECTION G - CONTRACT
ADMINISTRATION DATA

Any contract awarded from this RFP will contain the following:

[]{#__RefHeading___Toc124312137 .anchor}ARTICLE G.1. PROJECT OFFICER

The following Project Officer(s) will represent the Government for the
purpose of this contract:

\[To be specified prior to award\]

The Project Officer is responsible for: (1) monitoring the Contractor\'s
technical progress, including the surveillance and assessment of
performance and recommending to the Contracting Officer changes in
requirements; (2) interpreting the statement of work and any other
technical performance requirements; (3) performing technical evaluation
as required; (4) performing technical inspections and acceptances
required by this contract; and (5) assisting in the resolution of
technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as
agent of the Government under this contract. Only the Contracting
Officer has authority to: (1) direct or negotiate any changes in the
statement of work; (2) modify or extend the period of performance; (3)
change the delivery schedule; (4) authorize reimbursement to the
Contractor any costs incurred during the performance of this contract;
or (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its Project Officer designation.

[]{#__RefHeading___Toc124312138 .anchor}ARTICLE G.2. KEY PERSONNEL

Pursuant to the Key Personnel clause incorporated in this contract, the
following individual(s) is/are considered to be essential to the work
being performed hereunder:

  --------------------- ------------------------- -----------------------
  NAME                                            TITLE

                        \[To be specified prior   
                        to award\]                
  --------------------- ------------------------- -----------------------

*[Note: Invoicing Clauses will depend on type of awarde]{.mark}e*

[]{#__RefHeading___Toc124312139 .anchor}ARTICLE G.3. INVOICE
SUBMISSION/CONTRACT FINANCING REQUEST

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

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

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

Contract No. (This is the 17 digit number that appears in Block 2 of the
SF-26, i.e. HHSN266200711000C.)

ADB Contract No. (This is the 10 digit number that appears in the upper
left hand corner of the SF-26, i.e. N01-AI-71234.)

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

Contracting Officer

Office of Acquisitions

DEA, NIAID, NIH, DHHS

6700-B Rockledge Drive, Room 3214, MSC 7612

Bethesda, Maryland 20892-7612

(Express Mail: Bethesda, MD 20817)

\(2\) Inquiries regarding payment of invoices should be directed to the
designated billing office, (301) 496-0612.

[]{#__RefHeading___Toc124312140 .anchor}ARTICLE G.3. INVOICE
SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

a\. Invoice/Financing Request Instructions and Contract Financial
Reporting for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are
attached and made part of this contract. The instructions and the
following directions for the submission of invoices/financing request
must be followed to meet the requirements of a \"proper\" payment
request pursuant to FAR 32.9.

> These instructions also provide for the submission of financial and
> personnel reporting required by HHSAR 342.7002.

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

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

Contract No. (This is the 17 digit number that appears in Block 2 of the
SF-26, i.e. HHSN266200701234C.)

ADB Contract No. (This is the 10 digit number that appears in the upper
left hand corner of the SF-26, i.e. N01-AI-71234.)

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

Contracting Officer

Office of Acquisitions

DEA, NIAID, NIH, DHHS

6700-B Rockledge Drive, Room 3214, MSC 7612

Bethesda, Maryland 20892-7612

(Express Mail: Bethesda, MD 20817)

\(2\) Inquiries regarding payment of invoices should be directed to the
designated billing office, (301) 496-0612.

[]{#__RefHeading___Toc124312141 .anchor}ARTICLE G.4. LETTER OF CREDIT
PAYMENT INFORMATION

a\. Advance payments will be provided under Letter of Credit Number in
accordance with Alternate V, Advance Payments Without Special Bank
Account, of FAR Clause 52.232-12, Advance Payments. This clause is
provided in full text in Article I.4. of this contract.

> The contractor shall withdraw funds pursuant to Department of Treasury
> Circular 1075 (31 CFR Part 205,
> [[http://www.access.gpo.gov/nara/cfr/waisidx_00/31cfr205_00.html]{.underline}](http://www.access.gpo.gov/nara/cfr/waisidx_00/31cfr205_00.html)
> ).
>
> \(1\) Invoice/Financing Request Instructions for NIH
> Cost-Reimbursement Type Contracts, NIH(RC)-1, are attached and made a
> part of this contract for the submission of completion and/or final
> invoices. The invoice instructions and the following directions for
> the submission of invoices/financing requests must be followed to meet
> the requirements of a \"proper\" invoice, pursuant to FAR 32.9. The
> completion and/or final invoice shall be submitted as follows:

An original and two copies to the following office:

Contracting Officer

Office of Acquisitions

DEA, NIAID, NIH, DHHS

6700-B Rockledge Drive, Room 3214, MSC 7612

Bethesda, Maryland 20892-7612

(Express Mail: Bethesda, MD 20817)

\(2\) Inquiries regarding payments should be directed to the following
office administering advance payments:

Division of Payment Management

11400 Rockville Pike

Rockwall Building #1, Suite 700

Rockville, MD 20852

([[http://www.dpm.psc.gov/]{.underline}](http://www.dpm.psc.gov/) under
Contacts)

b\. The Contractor shall include the following certification on every
invoice for reimbursable costs incurred with Fiscal Year funds subject
to the salary rate limitation provisions as specified in ARTICLE H. . of
this contract. For billing purposes, certified invoices are required for
the billing period during which the applicable Fiscal Year funds were
initially charged through the final billing period utilizing the
applicable Fiscal Year funds:

> \"I hereby certify that the salaries charged in this invoice are in
> compliance with P.L. \[cite the applicable Public Law Number for the
> a/applicable Fiscal Year as stated in ARTICLE H. .\] and ARTICLE H. .
> of the above referenced contract.\"

[]{#__RefHeading___Toc124312142 .anchor}ARTICLE G.5. CONTRACT FINANCIAL
REPORT

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

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

c\. The first financial report shall cover the period consisting of the
(FIRST FULL CALENDAR MONTH/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 (monthly/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 following is a listing of expenditure categories to be reported:

+---+---+---------------------------+------------------------------------+
| * |   |                           | **Percentage of**                  |
| * |   |                           |                                    |
| E |   |                           | **Effort/Hours**                   |
| x |   |                           |                                    |
| p |   |                           |                                    |
| e |   |                           |                                    |
| n |   |                           |                                    |
| d |   |                           |                                    |
| i |   |                           |                                    |
| t |   |                           |                                    |
| u |   |                           |                                    |
| r |   |                           |                                    |
| e |   |                           |                                    |
| C |   |                           |                                    |
| a |   |                           |                                    |
| t |   |                           |                                    |
| e |   |                           |                                    |
| g |   |                           |                                    |
| o |   |                           |                                    |
| r |   |                           |                                    |
| y |   |                           |                                    |
| * |   |                           |                                    |
| * |   |                           |                                    |
|   |   |                           |                                    |
| * |   |                           |                                    |
| * |   |                           |                                    |
| A |   |                           |                                    |
| * |   |                           |                                    |
| * |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
|   |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
| ( |   |                           |                                    |
| 1 |   |                           |                                    |
| \ |   |                           |                                    |
| ) |   |                           |                                    |
| D |   |                           |                                    |
| i |   |                           |                                    |
| r |   |                           |                                    |
| e |   |                           |                                    |
| c |   |                           |                                    |
| t |   |                           |                                    |
| L |   |                           |                                    |
| a |   |                           |                                    |
| b |   |                           |                                    |
| o |   |                           |                                    |
| r |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
|   | \ |                           |                                    |
|   | ( |                           |                                    |
|   | a |                           |                                    |
|   | \ |                           |                                    |
|   | ) |                           |                                    |
|   | P |                           |                                    |
|   | r |                           |                                    |
|   | i |                           |                                    |
|   | n |                           |                                    |
|   | c |                           |                                    |
|   | i |                           |                                    |
|   | p |                           |                                    |
|   | a |                           |                                    |
|   | l |                           |                                    |
|   | I |                           |                                    |
|   | n |                           |                                    |
|   | v |                           |                                    |
|   | e |                           |                                    |
|   | s |                           |                                    |
|   | t |                           |                                    |
|   | i |                           |                                    |
|   | g |                           |                                    |
|   | a |                           |                                    |
|   | t |                           |                                    |
|   | o |                           |                                    |
|   | r |                           |                                    |
+---+---+---------------------------+------------------------------------+
|   | \ |                           |                                    |
|   | ( |                           |                                    |
|   | b |                           |                                    |
|   | \ |                           |                                    |
|   | ) |                           |                                    |
|   | C |                           |                                    |
|   | o |                           |                                    |
|   | - |                           |                                    |
|   | P |                           |                                    |
|   | r |                           |                                    |
|   | i |                           |                                    |
|   | n |                           |                                    |
|   | c |                           |                                    |
|   | i |                           |                                    |
|   | p |                           |                                    |
|   | a |                           |                                    |
|   | l |                           |                                    |
|   | I |                           |                                    |
|   | n |                           |                                    |
|   | v |                           |                                    |
|   | e |                           |                                    |
|   | s |                           |                                    |
|   | t |                           |                                    |
|   | i |                           |                                    |
|   | g |                           |                                    |
|   | a |                           |                                    |
|   | t |                           |                                    |
|   | o |                           |                                    |
|   | r |                           |                                    |
+---+---+---------------------------+------------------------------------+
|   | \ |                           |                                    |
|   | ( |                           |                                    |
|   | c |                           |                                    |
|   | \ |                           |                                    |
|   | ) |                           |                                    |
|   | K |                           |                                    |
|   | e |                           |                                    |
|   | y |                           |                                    |
|   | P |                           |                                    |
|   | e |                           |                                    |
|   | r |                           |                                    |
|   | s |                           |                                    |
|   | o |                           |                                    |
|   | n |                           |                                    |
|   | n |                           |                                    |
|   | e |                           |                                    |
|   | l |                           |                                    |
+---+---+---------------------------+------------------------------------+
|   |   | \(i\)                     |                                    |
+---+---+---------------------------+------------------------------------+
|   |   | \(ii\)                    |                                    |
+---+---+---------------------------+------------------------------------+
|   |   | \(iii\)                   |                                    |
+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
| ( |   |                           |                                    |
| 2 |   |                           |                                    |
| \ |   |                           |                                    |
| ) |   |                           |                                    |
| O |   |                           |                                    |
| t |   |                           |                                    |
| h |   |                           |                                    |
| e |   |                           |                                    |
| r |   |                           |                                    |
| P |   |                           |                                    |
| r |   |                           |                                    |
| o |   |                           |                                    |
| f |   |                           |                                    |
| e |   |                           |                                    |
| s |   |                           |                                    |
| s |   |                           |                                    |
| i |   |                           |                                    |
| o |   |                           |                                    |
| n |   |                           |                                    |
| a |   |                           |                                    |
| l |   |                           |                                    |
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| r |   |                           |                                    |
| s |   |                           |                                    |
| o |   |                           |                                    |
| n |   |                           |                                    |
| n |   |                           |                                    |
| e |   |                           |                                    |
| l |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
| ( |   |                           |                                    |
| 3 |   |                           |                                    |
| \ |   |                           |                                    |
| ) |   |                           |                                    |
| P |   |                           |                                    |
| e |   |                           |                                    |
| r |   |                           |                                    |
| s |   |                           |                                    |
| o |   |                           |                                    |
| n |   |                           |                                    |
| n |   |                           |                                    |
| e |   |                           |                                    |
| l |   |                           |                                    |
|   |   |                           |                                    |
| - |   |                           |                                    |
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| t |   |                           |                                    |
| h |   |                           |                                    |
| e |   |                           |                                    |
| r |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
| ( |   |                           |                                    |
| 4 |   |                           |                                    |
| \ |   |                           |                                    |
| ) |   |                           |                                    |
| F |   |                           |                                    |
| r |   |                           |                                    |
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| n |   |                           |                                    |
| g |   |                           |                                    |
| e |   |                           |                                    |
| B |   |                           |                                    |
| e |   |                           |                                    |
| n |   |                           |                                    |
| e |   |                           |                                    |
| f |   |                           |                                    |
| i |   |                           |                                    |
| t |   |                           |                                    |
| s |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
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| 5 |   |                           |                                    |
| \ |   |                           |                                    |
| ) |   |                           |                                    |
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| c |   |                           |                                    |
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| n |   |                           |                                    |
| t |   |                           |                                    |
| a |   |                           |                                    |
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| n |   |                           |                                    |
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| l |   |                           |                                    |
| P |   |                           |                                    |
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| p |   |                           |                                    |
| e |   |                           |                                    |
| r |   |                           |                                    |
| t |   |                           |                                    |
| y |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
| ( |   |                           |                                    |
| 6 |   |                           |                                    |
| \ |   |                           |                                    |
| ) |   |                           |                                    |
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| l |   |                           |                                    |
| i |   |                           |                                    |
| e |   |                           |                                    |
| s |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
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| 7 |   |                           |                                    |
| \ |   |                           |                                    |
| ) |   |                           |                                    |
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| t |   |                           |                                    |
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| o |   |                           |                                    |
| s |   |                           |                                    |
| t |   |                           |                                    |
| s |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
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| 8 |   |                           |                                    |
| \ |   |                           |                                    |
| ) |   |                           |                                    |
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| a |   |                           |                                    |
| v |   |                           |                                    |
| e |   |                           |                                    |
| l |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
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| 9 |   |                           |                                    |
| \ |   |                           |                                    |
| ) |   |                           |                                    |
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| s |   |                           |                                    |
| t |   |                           |                                    |
| s |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
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| 0 |   |                           |                                    |
| \ |   |                           |                                    |
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| m |   |                           |                                    |
| P |   |                           |                                    |
| a |   |                           |                                    |
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+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
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| 1 |   |                           |                                    |
| 1 |   |                           |                                    |
| \ |   |                           |                                    |
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| o |   |                           |                                    |
| s |   |                           |                                    |
| t |   |                           |                                    |
| s |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
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| 1 |   |                           |                                    |
| 2 |   |                           |                                    |
| \ |   |                           |                                    |
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| t |   |                           |                                    |
| s |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
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| 3 |   |                           |                                    |
| \ |   |                           |                                    |
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| o |   |                           |                                    |
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| t |   |                           |                                    |
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+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
| ( |   |                           |                                    |
| 1 |   |                           |                                    |
| 4 |   |                           |                                    |
| \ |   |                           |                                    |
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| d |   |                           |                                    |
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| o |   |                           |                                    |
| s |   |                           |                                    |
| t |   |                           |                                    |
| s |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
| ( |   |                           |                                    |
| 1 |   |                           |                                    |
| 5 |   |                           |                                    |
| \ |   |                           |                                    |
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| n |   |                           |                                    |
| s |   |                           |                                    |
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+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
| ( |   |                           |                                    |
| 1 |   |                           |                                    |
| 6 |   |                           |                                    |
| \ |   |                           |                                    |
| ) |   |                           |                                    |
| T |   |                           |                                    |
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| t |   |                           |                                    |
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| C |   |                           |                                    |
| o |   |                           |                                    |
| s |   |                           |                                    |
| t |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
| ( |   |                           |                                    |
| 1 |   |                           |                                    |
| 7 |   |                           |                                    |
| \ |   |                           |                                    |
| ) |   |                           |                                    |
| F |   |                           |                                    |
| e |   |                           |                                    |
| e |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
| \ |   |                           |                                    |
| ( |   |                           |                                    |
| 1 |   |                           |                                    |
| 8 |   |                           |                                    |
| \ |   |                           |                                    |
| ) |   |                           |                                    |
| T |   |                           |                                    |
| o |   |                           |                                    |
| t |   |                           |                                    |
| a |   |                           |                                    |
| l |   |                           |                                    |
| C |   |                           |                                    |
| o |   |                           |                                    |
| s |   |                           |                                    |
| t |   |                           |                                    |
| P |   |                           |                                    |
| l |   |                           |                                    |
| u |   |                           |                                    |
| s |   |                           |                                    |
| F |   |                           |                                    |
| i |   |                           |                                    |
| x |   |                           |                                    |
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| d |   |                           |                                    |
| F |   |                           |                                    |
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| e |   |                           |                                    |
+---+---+---------------------------+------------------------------------+
|   |   |                           |                                    |
+---+---+---------------------------+------------------------------------+

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

[]{#__RefHeading___Toc124312143 .anchor}ARTICLE G.6. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR
Chapter 1) Clause 52.216-7(d)(2), \"Allowable Cost and Payment\"
incorporated by reference in this contract in Part II, Section I, the
cognizant Contracting Officer representative responsible for negotiating
provisional and/or final indirect cost rates is identified as follows:

> Director, Division of Financial Advisory Services
>
> Office of 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.

[]{#__RefHeading___Toc124312144 .anchor}ARTICLE G.7. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property
provided by the contracting agency or if the Contracting Officer
authorizes in the preaward negotiation process, the acquisition of
property (other than real property), this ARTICLE will include
applicable provisions and incorporate the DHHS Publication (OS) 686,
entitled, **Contractor\'s Guide for Control of Government Property**,
(1990) which can be found at:

[[http://knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm]{.underline}](http://knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm)

[]{#__RefHeading___Toc124312145 .anchor}ARTICLE G.8. POST AWARD
EVALUATION OF CONTRACTOR PERFORMANCE

a\. [Contractor Performance Evaluations]{.underline}

> 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 semi-annually to coincide with the anniversary date of the
> contract.
>
> Interim and final evaluations will be provided to the Contractor as
> soon as practicable after completion of the evaluation. The Contractor
> will be permitted thirty days to review the document and to submit
> additional information or a rebutting statement. If agreement cannot
> be reached between the parties, the matter will be referred to an
> individual one level above the Contracting Officer, whose decision
> will be final.
>
> Copies of the evaluations, contractor responses, and review comments,
> if any, will be retained as part of the contract file, and may be used
> to support future award decisions.

b\. [Electronic Access to Contractor Performance
Evaluations]{.underline}

> 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://oamp.od.nih.gov/OD/CPS/cps.asp]{.underline}](http://oamp.od.nih.gov/OD/CPS/cps.asp)

> The registration process requires the contractor to identify an
> individual that will serve as a primary contact and who will be
> authorized access to the evaluation for review and comment. In
> addition, the contractor will be required to identify an alternate
> contact who will be responsible for notifying the cognizant
> contracting official in the event the primary contact is unavailable
> to process the evaluation within the required 30-day time frame.

[]{#__RefHeading___Toc124312146 .anchor}SECTION H - SPECIAL CONTRACT
REQUIREMENTS

[]{#__RefHeading___Toc124312147 .anchor}ARTICLE H.1. HUMAN SUBJECTS

Research involving human subjects shall not be conducted under this
contract until the protocol developed in Phase I has been approved by
NIAID, written notice of such approval has been provided by the
Contracting Officer, and the Contractor has provided to the Contracting
Officer a properly completed \"Protection of Human Subjects Assurance
Identification/IRB Certification/Declaration of Exemption\", Form OMB
No. 0990-0263(formerly Optional Form 310), certifying IRB review and
approval of the protocol. The human subject certification can be met by
submission of the Contractor\'s self designated form, provided that it
contains the information required by the \"Protection of Human Subjects
Assurance Identification/IRB Certification/Declaration of Exemption\",
Form OMB No. 0990-0263(formerly Optional Form 310).

[]{#__RefHeading___Toc124312148 .anchor}ARTICLE H.2. REQUIRED EDUCATION
IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

NIH policy requires education on the protection of human subject
participants for all investigators receiving NIH contract awards for
research involving human subjects. For a complete description of the NIH
Policy announcement on required education in the protection of human
subject participants, the contractor should access the [NIH Guide for
Grants and Contracts]{.underline} Announcement dated June 5, 2000 at the
following website:
[[http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html).
The information below is a summary of the NIH Policy Announcement:

The contractor shall maintain the following information: (1) a list of
the names and titles of the principal investigator and any other
individuals working under the contract who are responsible for the
design and/or conduct of the research; (2) the title of the education
program(s) in the protection of human subjects that has been completed
for each named personnel and; (3) a one sentence description of the
educational program(s) listed in (2) above. This requirement extends to
investigators and all individuals responsible for the design and/or
conduct of the research who are working as subcontractors or consultants
under the contract.

Prior to any substitution of the Principal Investigator or any other
individuals responsible for the design and/or conduct of the research
under the contract, the contractor shall provide the following written
information to the Contracting Officer: the title of the education
program and a one sentence description of the program that has been
completed by the replacement.

[]{#__RefHeading___Toc124312149 .anchor}ARTICLE H.3. DATA AND SAFETY
MONITORING IN CLINICAL TRIALS

The contractor is directed to the full text of the NIH Policy regarding
Data and Safety Monitoring and Reporting of Adverse Events, which may be
found at the following web sites:

> [[http://grants.nih.gov/grants/guide/notice-files/not98-084.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/not98-084.html)
>
> [[http://grants.nih.gov/grants/guide/notice-files/not99-107.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/not99-107.html)
>
> [[http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html#http://grants.nih.gov/grants/guide/notice-files/NOH-OD-00-03)

The contractor must comply with the NIH Policy cited in these NIH
Announcements and any other data and safety monitoring requirements
found elsewhere in this contract.

Data and Safety Monitoring shall be performed in accordance with the
approved Data and Safety Monitoring Plan.

The Data and Safety Monitoring Board and Plan shall be established and
approved prior to beginning the conduct of the clinical trial.

[]{#__RefHeading___Toc124312150 .anchor}ARTICLE H.4. HUMAN MATERIALS
(ASSURANCE OF OHRP COMPLIANCE)

The acquisition and supply of all human specimen material (including
fetal material) used under this contract shall be obtained by the
Contractor in full compliance with applicable State and Local laws and
the provisions of the Uniform Anatomical Gift Act in the United States,
and no undue inducements, monetary or otherwise, will be offered to any
person to influence their donation of human material.

The Contractor shall provide written documentation that all human
materials obtained as a result of research involving human subjects
conducted under this contract, by collaborating sites, or by
subcontractors identified under this contract, were obtained with prior
approval by the Office for Human Research Protections (OHRP) of an
Assurance to comply with the requirements of 45 CFR 46 to protect human
research subjects. This restriction applies to all collaborating sites
without OHRP-approved Assurances, whether domestic or foreign, and
compliance must be ensured by the Contractor.

Provision by the Contractor to the Contracting Officer of a properly
completed \"Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption\", Form OMB No.
0990-0263(formerly Optional Form 310), certifying IRB review and
approval of the protocol from which the human materials were obtained
constitutes the written documentation required. The human subject
certification can be met by submission of a self designated form,
provided that it contains the information required by the \"Protection
of Human Subjects Assurance Identification/IRB Certification/Declaration
of Exemption\", Form OMB No. 0990-0263(formerly Optional Form 310).

[Note: One of the following two clauses will be included in the contract
depending on the status of HPSCRG approval at contract award.]{.mark}

**ARTICLE H.5. HUMAN EMBRYONIC GERM CELL (HEGC) RESEARCH**

**All HPSCRG (Human Pluripotent Stem Cell Review Group) approved
research involving human embryonic germ cells shall be conducted in
accordance with the NIH Guidelines for Research Using Human Pluripotent
Stem Cells ()**

ARTICLE H.5. HUMAN EMBRYONIC GERM CELL (HEGC) RESEARCH

Federally funded research involving the use of human embryonic germ
cells derived from fetal tissue shall not be conducted under this
contract until Human Pluripotent Stem Cell Review Group (HPSCRG) review
and approval has been obtained. Once approved by the HPSCRG, all
research shall be conducted in accordance with the NIH Guidelines for
Research Using Human Pluripotent Stem Cells ().

Phase(s)/Option Period(s) \_\_\_\_\_\_\_\_\_\_\_which require(s)
research involving the use of human embryonic germ cells shall not be
conducted under this contract until the HPSCRG review and approval have
been obtained, and documented by written notice of such approval by the
contracting officer. If the HPSCRG disapproves the documentation
presented by the contractor, the contract may be terminated in
accordance with the Termination of Convenience Clause referenced in
Article I.1. of this contract/ OR the Contracting Officer may elect not
to exercise Option(s) \_\_\_\_\_\_\_\_\_ of this contract in accordance
with the Option Clause referenced in Article I.3. of this contract. In
addition, it may be necessary for the Contracting Officer to invoke FAR
Clause 52.242‑15, Stop Work Order, referenced in Article F.3 Clauses
Incorporated by Reference, of this contract if the review and approval
process cannot be accomplished in a time frame that allows for
continuity of this research effort.

**ARTICLE H.6. HUMAN EMBRYONIC STEM CELL (HESC) RESEARCH**

**All research conducted under this contract shall involve the use of
existing human embryonic stem cells established under the NIH Embryonic
Stem Cell Registry only.**

[]{#__RefHeading___Toc124312152 .anchor}ARTICLE H.7. CONTINUED BAN ON
FUNDING OF HUMAN EMBRYO RESEARCH

a\. Pursuant to Public Law(s) cited in paragraph b. below, NIH is
prohibited from using appropriated funds to support human embryo
research. Contract funds may not be used for (1) the creation of a human
embryo or embryos for research purposes; or (2) research in which a
human embryo or embryos are destroyed, discarded, or knowingly subjected
to risk of injury or death greater than that allowed for research on
fetuses in utero under 45 CFR 46.208(a)(2) and Section 498(b) of the
Public Health Service Act (42 U.S.C. 289g(b)). The term \"human embryo
or embryos\" includes any organism, not protected as a human subject
under 45 CFR 46 as of the date of the enactment of this Act, that is
derived by fertilization, parthenogenesis, cloning, or any other means
from one or more human gametes or human diploid cells.

> Additionally, in accordance with a March 4, 1997 Presidential
> Memorandum, Federal funds may not be used for cloning of human beings.

+-----------------------+-----------------+---------------------------+
| b\. **Public Law and  | **Fiscal Year** | > **Period Covered**      |
| Section No.**         |                 |                           |
+-----------------------+-----------------+---------------------------+

\[Applicable information to be included at award\]

[]{#__RefHeading___Toc124312153 .anchor}ARTICLE H.8. NEEDLE EXCHANGE

a\. Pursuant to Public Law(s) cited in paragraph b., below, contract
funds shall not be used to carry out any program of distributing sterile
needles or syringes for the hypodermic injection of any illegal drug.

+----------------------+------------------+---------------------------+
| b\. **Public Law and | **Fiscal Year**  | > **Period Covered**      |
| Section No.**        |                  |                           |
+----------------------+------------------+---------------------------+

\[Applicable information to be included at award\]

[]{#__RefHeading___Toc124312154 .anchor}ARTICLE H.9. PRIVACY ACT

This procurement action requires the Contractor to do one or more of the
following: design, develop, or operate a system of records on
individuals to accomplish an agency function in accordance with the
Privacy Act of 1974, Public Law 93-579, December 31, 1974 (5 USC 552a)
and applicable agency regulations. Violation of the Act may involve the
imposition of criminal penalties.

The Privacy Act System of Records applicable to this project is Number
09-25-0200. This document is incorporated into this contract as
Attachment 23.

[]{#__RefHeading___Toc124312155 .anchor}ARTICLE H.10. ANIMAL WELFARE

All research involving live, vertebrate animals shall be conducted in
accordance with the Public Health Service Policy on Humane Care and Use
of Laboratory Animals. This policy may be accessed at:

[[http://grants1.nih.gov/grants/olaw/references/phspol.htm]{.underline}](http://grants1.nih.gov/grants/olaw/references/phspol.htm)

[]{#__RefHeading___Toc124312156 .anchor}

ARTICLE H.11. INTRODUCTION OF RODENTS AND RODENT PRODUCTS

No rodent or rodent product shall be delivered into the NIH, NIAID
environment (NIH) directly, or through collaborative research or holding
facilities under contract to NIAID except by permit. Direct shipments to
NIH from a Division of Veterinary Resources (DVR), Office of Research
Services (ORS) approved source will be considered exempt. Non-exempt
sources must be approved by permit issued through the DVR, ORS. The
permit must be obtained by the Contractor prior to the shipment to NIH
of the rodents and/or rodent products. The Contractor must be sure that
this permit exists and is current before transferring rodents or rodent
products into the NIH, NIAID environment. Refusal or negligence to do so
will be considered a material breach of contract and may be treated as
any other such material breach. Applications for permits should be
submitted by facsimile not less than 30 days prior (60 days in
situations where quarantine is likely) to shipping date to: NIH Division
of Veterinary Resources (DVR), Office of Research Services (ORS),
Building 14G, Service Rd. South, Room 102, BETHESDA MD 20892-5210,
(301)496-2527, FAX: (301) 402-0352.

[]{#__RefHeading___Toc124312157 .anchor}ARTICLE H.12. RESEARCH INVOLVING
HUMAN FETAL TISSUE

All research involving human fetal tissue shall be in conducted in
accordance with the Public Health Service Act, 42 U.S.C. 289g‑1 and
289g‑2. Implementing regulations and guidance for conducting research on
human fetal tissue may be found at 45 CFR 46, Subpart B and any
subsequent revisions to this NIH Guide to Grants and Contracts
(\"Guide\") Notice.

The contractor shall make available, for audit by the Secretary, DHHS,
the physician statements and informed consents required by 42 USC
289g‑1(b) and (c), or ensure DHHS access to those records, if maintained
by an entity other than the contractor.

[]{#__RefHeading___Toc124312158 .anchor}ARTICLE H.13. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause
set forth in ARTICLE I.3., the contract will consist only of (Phase I or
Year I) of the Statement of Work as defined in Sections C and F of the
contract. Pursuant to clause 52.217- 6 set forth in ARTICLE I.3. of this
contract, the Government may, by unilateral contract modification,
require the Contractor to perform the options in the Statement of Work
as also defined in Sections C and F of this contract. If the Government
exercises this option, notice must be given at least 60 days prior to
the expiration date of this contract, and the estimated cost \[plus
fixed fee\] of the contract will be increased as set forth in Article
B.3.

[]{#__RefHeading___Toc124312159 .anchor}ARTICLE H.14. SUBCONTRACTING
PROVISIONS

a\. Small Business Subcontracting Plan

> \(1\) The Small Business Subcontracting Plan, dated TBD is attached
> hereto and made a part of this contract.
>
> \(2\) The failure of any Contractor or subcontractor to comply in good
> faith with FAR Clause 52.219-8, entitled \"Utilization of Small
> Business Concerns\" incorporated in this contract and the attached
> Subcontracting Plan, will be a material breach of such contract or
> subcontract and subject to the remedies reserved to the Government
> under FAR Clause 52.219-16 entitled, \"Liquidated
> Damages-Subcontracting Plan.\"

b\. Subcontracting Reports

> \(1\) **Subcontracting Report for Individual Contracts, SF-294**

The Contractor shall submit the original and one (1) copy of
Subcontracting Report for Individual Contracts, SF-294 in accordance
with the instructions on the report as referenced in Public Law 95-507,
Section 211. In addition to the information contained in the General
Instructions on the back of this form for Block 17, \"Remarks,\" the
Contractor shall provide an explanation **for any category** of small
business subcontracting for which there were no dollars reported since
the last reporting period.

Regardless of the effective date of this contract, the Report shall be
submitted on the following dates for the entire life of this contract:

April 30th

October 30th

The Report shall be sent to the Contracting Officer at following
address:

Contracting Officer

Office of Acquisitions

DEA, NIAID, NIH, DHHS

6700-B Rockledge Drive, Room 3214, MSC 7612

Bethesda, Maryland 20892-7612

(Express Mail: Bethesda, MD 20817)

> \(2\) **Summary Subcontract Report, SF-295**

The Contractor shall submit two (2) copies of Summary Subcontract
Report, SF-295 in accordance with the instructions on the report as
referenced in Public Law 95-507, Section 211. Regardless of the
effective date of this contract, the Summary Subcontract Report shall be
submitted annually on the following date for the entire life of this
contract:

October 30th

> One copy of this report shall be sent to the Contracting Officer at
> the address above. One copy of this Report shall be mailed to the
> Office of Small and Disadvantaged Business Utilization, DHHS at the
> following addresses:

**Office of Small and Disadvantaged Business Utilization**

Department of Health and Human Services

Hubert H. Humphrey Bldg., Room 360G

200 Independence Avenue, S.W.

Washington, D.C. 20201

\(3\) The contractor shall also send an \"Information Copy\" of the
SF-295 to the Cognizant Commercial Representative (CMR) at the address
provided by the SBA. The Contractor should call SBA Headquarters in
Washington, DC at (202) 690-7235, for the correct address if unknown.

[]{#__RefHeading___Toc124312160 .anchor}ARTICLE H.15. SALARY RATE
LIMITATION LEGISLATION PROVISIONS

a\. Pursuant to the P.L.(s) cited in paragraph b., below, no NIH Fiscal
Year funds may be used to pay the direct salary of an individual through
this contract at a rate in excess of the applicable amount shown or the
applicable Executive Level for the fiscal year covered. Direct salary is
exclusive of fringe benefits, overhead and general and administrative
expenses (also referred to as "indirect costs" or "facilities and
administrative (F&A) costs"). Direct salary has the same meaning as the
term "institutional base salary." An individual\'s direct salary (or
institutional base salary) is the annual compensation that the
contractor pays for an individual\'s appointment whether that
individual\'s time is spent on research, teaching, patient care or other
activities. Direct salary (or institutional base salary) excludes any
income that an individual may be permitted to earn outside of duties to
the contractor. The per year salary rate limitation also applies to
individuals proposed under subcontracts. It does not apply to fees paid
to consultants. If this is a multiple year contract, it may be subject
to unilateral modifications by the Government if an individual\'s salary
rate used to establish contract funding exceeds any salary rate
limitation subsequently established in future HHS appropriation acts.

+------------------+----------------------+---------------------------+
| b\. **Public Law | **Fiscal Year**      | > **Dollar Amount of**    |
| No.**            |                      | >                         |
|                  |                      | > **Salary Limitation\*** |
+------------------+----------------------+---------------------------+

\[Applicable information to be included at award\]

c\. Payment of direct salaries is limited to the Executive Level I rate
which was in effect on the date(s) the expense was incurred.

> \* For the period 10/1/04 - 12/30/04, the Executive Level I rate is
> \$175,700. Effective January 1, 2005, the Executive Level I rate
> increased to \$180,100 and will remain at that rate until it is
> revised. See the web site listed below for the Executive Schedule
> rates of pay:

***FOR FY05 EXECUTIVE LEVEL SALARIES EFFECTIVE JANUARY 1, 2005:***

**[[http://www.opm.gov/oca/05tables/html/ex.asp]{.underline}](http://www.opm.gov/oca/05tables/html/ex.asp)**

> ***(NOTE: This site shows the CY 05 rates. For previous years, click
> on "salaries and wages" and then scroll down to the bottom of the page
> and click on the year to locate the desired Executive Level salary
> rates).***

[]{#__RefHeading___Toc124312161 .anchor}ARTICLE H.16. INFORMATION
SECURITY

The Statement of Work (SOW) requires the contractor to develop or access
Federal automated information systems; therefore, the contractor shall
comply with the "DHHS Information Security Program Policy"
([[http://www.hhs.gov/read/irmpolicy/FINALHHSInformationSecurityProgramP.doc]{.underline}](http://www.hhs.gov/read/irmpolicy/FINALHHSInformationSecurityProgramP.doc))
as set forth below. The contractor shall include this provision in any
subcontract awarded under this contract.

a\. [Information Type]{.underline}

> ***\*\*\*\* (NOTE: The resultant contract will include the Information
> Type, however for the purposes of this RFP, the Information Type is
> specified in SECTION L.2.b. Technical Proposal Instructions of this
> RFP.) \*\*\*\****

**\[\]** **Administrative, Management and Support Information:**

**\[\] Mission Based Information:**

b\. [Security Categories and Levels]{.underline}

> ***\*\*\*\* (NOTE: The resultant contract will include the Security
> Categories and Levels, however for the purposes of this RFP, the
> Security Categories and Levels are specified in SECTION L.2.b.
> Technical Proposal Instructions of this RFP.) \*\*\*\****

Confidentiality Level: **\[ \]** Low **\[X\]** Moderate **\[ \]** High

Integrity Level: **\[ \]** Low **\[X\]** Moderate **\[ \]** High

Availability Level: **\[ \]** Low **\[X\]** Moderate **\[ \]** High

**Overall Level: \[ \] Low \[X\] Moderate \[ \] High**

c\. [Position Sensitivity Designations]{.underline}

> \(1\) The following position sensitivity designations and associated
> clearance and investigation requirements apply under this contract:
>
> ***\*\*\*\* (NOTE: The resultant contract will include the Position
> Sensitivity Designations, however for the purposes of this RFP, the
> Position Sensitivity Designations applicable to this RFP are specified
> in SECTION L.2.b. Technical Proposal Instructions of this RFP.)
> \*\*\*\****

**\[ \] Level 6: Public Trust - High Risk (Requires Suitability
Determination with a BI).** Contractor employees assigned to a Level 6
position are subject to a Background Investigation (BI).

**\[X\] Level 5: Public Trust - Moderate Risk (Requires Suitability
Determination with NACIC, MBI or LBI).** Contractor employees assigned
to a Level 5 position with no previous investigation and approval shall
undergo a National Agency Check and Inquiry Investigation plus a Credit
Check (NACIC), a Minimum Background Investigation (MBI), or a Limited
Background Investigation (LBI).

**\[ \] Level 1: Non Sensitive (Requires Suitability Determination with
an NACI).** Contractor employees assigned to a Level 1 position are
subject to a National Agency Check and Inquiry Investigation (NACI).

> \(2\) The contractor shall submit a roster, by name, position and
> responsibility, of all IT staff working under the contract. The roster
> shall be submitted to the Project Officer, with a copy to the
> Contracting Officer, within 14 days of the effective date of the
> contract. Any revisions to the Roster as a result of staffing changes
> shall be submitted within fifteen (15) calendar days of the change.
> The Contracting Officer shall notify the contractor of the appropriate
> level of suitability investigations to be performed. An electronic
> template, "Roster of Employees Requiring Suitability
> Investigations,"\* is available for contractor use at:

[[http://ais.nci.nih.gov/forms/Suitability-roster.xls]{.underline}](http://ais.nci.nih.gov/forms/Suitability-roster.xls)

> *\*Note: The website listed at [http://ais.nci.nih.gov]{.underline}
> provides information about IT Security Policies and the background
> investigation process.  NCI points of contract do not apply to this
> contract.  Contact your contract specialist for applicable staff
> information*.

Upon receipt of the Government's notification of applicable Suitability
Investigation required, the contractor shall complete and submit the
required forms within 30 days of the notification. Additional submission
instructions can be found at the "NCI Information Technology Security
Policies, Background Investigation Process" website:
[[http://ais.nci.nih.gov]{.underline}](http://ais.nci.nih.gov/).

Contractor employees who have had a background investigation conducted
by the U.S. Office of Personnel Management (OPM) within the last five
years may only require an updated or upgraded investigation.

\(3\) Contractor employees shall comply with the DHHS criteria for the
assigned position sensitivity designations prior to performing any work
under this contract. The following exceptions apply:

Levels 5 and 1: Contractor employees may begin work under the contract
after the contractor has submitted the name, position and responsibility
of the employee to the Project Officer, as described in paragraph c.(2)
above.

Level 6: In special circumstances the Project Officer may request a
waiver of the preappointment investigation. If the waiver is granted,
the Project Officer will provide written authorization for the
contractor employee to work under the contract.

d\. [Systems Security Plan]{.underline}

> The contractor shall protect Federal automated information systems
> that are developed or accessed by the contractor. System security
> shall be accomplished in accordance with the contractor's System
> Security Plan dated February 1, 2007. The plan must:

\(1\) Include a detailed plan of present and proposed systems security
programs commensurate with the size and complexity of the requirements
of the Statement of Work. The contractor shall use the **NIH Systems
Security Plan Template** (detailed) at
[[http://irm.cit.nih.gov/security/secplantemp.doc]{.underline}](http://irm.cit.nih.gov/security/secplantemp.doc)
or **NIH Systems Security Plan Outline** (outline only) at
[[http://irm.cit.nih.gov/nihsecurity/Security_Plan_Outline.doc]{.underline}](http://irm.cit.nih.gov/nihsecurity/Security_Plan_Outline.doc).

***\[OR** (To be determined during negotiations)**\]***

\(1\) Include a plan of present and proposed systems security programs
commensurate with the size and complexity of the requirements of the
Statement of Work. The minimum areas to be addressed include, but are
not limited to administrative, technical, and physical security as
follows:

\(i\) Security Awareness Training

\(ii\) Logical Access Control

-Network (ex: firewall)

-System (ex: network OS, tcp wrappers, SSH)

-Application (ex: S-LDAP, SSL)

-Remote Access (ex: VPN)

-Monitoring and support (ex: IDS, pager, NOC)

\(iii\) Protection against data loss

-OS security (ex: patch management, configuration)

-Application security (ex: patch management)

-Database security

-Back-up and recovery

-Fault tolerance, high availability

\(iv\) Malicious Code Protection (ex: Antivirus, filtering of e-mail
attachments, etc)

\(v\) Physical Security

-Access control (ex: locks, guards)

-Power conditioning and/or UPS

-Air conditioning

-Fire protection

> Include an acknowledgment of its understanding of the security
> requirements.
>
> Provide similar information for any proposed subcontractor developing
> or accessing an AIS.

e\. [Rules of Behavior]{.underline}

> The contractor shall comply with the DHHS Rules of Behavior set forth
> in **DHHS Information Security Program Policy Handbook, Appendix G**
> at:

[[http://intranet.hhs.gov/infosec/docs/policies_guides/ISPPH/PG_ISHbkv2_11_12_2004.pdf]{.underline}](http://intranet.hhs.gov/infosec/docs/policies_guides/ISPPH/PG_ISHbkv2_11_12_2004.pdf);
and

the **NIH Information Technology General Rules of Behavior** at:

[[http://irm.cit.nih.gov/security/nihitrob.html]{.underline}](http://irm.cit.nih.gov/security/nihitrob.html).

f\. [Information Security Training]{.underline}

> Each contractor employee shall complete the NIH Computer Security
> Awareness Training
> ([[http://irtsectraining.nih.gov/]{.underline}](http://irtsectraining.nih.gov/))
> prior to performing any contract work, and on an annual basis
> thereafter, during the period of performance of this contract.
>
> The contractor shall maintain a listing by name and title of each
> individual working under this contract that has completed the NIH
> required training. Any additional security training completed by
> contractor staff shall be included on this listing.

Contractor staff shall complete the following additional training prior
to performing any work under this contract:

***\*\*\*\* \[Additional courses will be listed here in the resultant
contract, if applicable.\] \*\*\*\****

g\. [Personnel Security Responsibilities]{.underline}

> The contractor shall perform and document the actions identified in
> the "Employee Separation Checklist", attached and made a part of this
> contract, when a contractor employee terminates work under this
> contract. All documentation shall be made available to the Project
> Officer and/or Contracting Officer upon request

h\. [Commitment to Protect Departmental Information Systems and
Data]{.underline}

\(1\) Contractor Agreement

The Contractor shall not release, publish, or disclose sensitive
Department information to unauthorized personnel, and shall protect such
information in accordance with provisions of the following laws and any
other pertinent laws and regulations governing the confidentiality of
sensitive information:

-18 U.S.C. 641 (Criminal Code: Public Money, Property or Records)

-18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information)

-Public Law 96-511 (Paperwork Reduction Act)

\(2\) Contractor-Employee Non-Disclosure Agreements

Each contractor employee who may have access to sensitive Department
information under this contract shall complete Commitment To Protect
Non-Public Information - Contractor Agreement. A copy of each signed and
witnessed Non-Disclosure agreement shall be submitted to the Project
Officer prior to performing any work under the contract.

i\. [References]{.underline}

1.  DHHS Information Security Program Policy:
    [[http://www.hhs.gov/ohr/manual/pssh.pdf]{.underline}](http://www.hhs.gov/ohr/manual/pssh.pdf)

2.  DHHS Personnel Security/Suitability Handbook:
    [[http://www.hhs.gov/ohr/manual/pssh.pdf]{.underline}](http://www.hhs.gov/ohr/manual/pssh.pdf)

3.  NIST Special Publication 800-16, Information Technology Security
    Training Requirements:

[[http://csrc.nist.gov/publications/nistpubs/800-16/800-16.pdf]{.underline}](http://csrc.nist.gov/publications/nistpubs/800-16/800-16.pdf)

Appendix A-D:
[[http://csrc.nist.gov/publications/nistpubs/800-16/AppendixA-D.pdf]{.underline}](http://csrc.nist.gov/publications/nistpubs/800-16/AppendixA-D.pdf)

4.  NIST SP 800-18, Guide for Developing Security Plans for Information
    Technology Systems:

[[http://csrc.nist.gov/publications/nistpubs/index.html]{.underline}](http://csrc.nist.gov/publications/nistpubs/index.html)

5.  NIST SP 800-60, Guide for Mapping Types of Information and
    Information Systems to Security Categories, Volume I:
    [[http://csrc.nist.gov/publications/nistpubs/800-60/SP800-60V1-final.pdf]{.underline}](http://csrc.nist.gov/publications/nistpubs/800-60/SP800-60V1-final.pdf)

6.  NIST SP 800-60, Guide for Mapping Types of Information and
    Information Systems to Security Categories, Volume II:
    [[http://csrc.nist.gov/publications/nistpubs/800-60/SP800-60V2-final.pdf]{.underline}](http://csrc.nist.gov/publications/nistpubs/800-60/SP800-60V1-final.pdf)

7.  NIST SP 800-64, Security Considerations in the Information System
    Development Life Cycle:

[[http://csrc.nist.gov/publications/nistpubs/800-64/NIST-SP800-64.pdf]{.underline}](http://csrc.nist.gov/publications/nistpubs/800-64/NIST-SP800-64.pdf)

8.  NIH Computer Security Awareness Training Course:
    [[http://irtsectraining.nih.gov/]{.underline}](http://irtsectraining.nih.gov/)

9.  Roster of Employees Requiring Suitability Investigations:
    [[http://ais.nci.nih.gov/forms/Suitability-roster.xls]{.underline}](http://ais.nci.nih.gov/forms/Suitability-roster.xls)

10. NCI Information Technology Security Policies, Background
    Investigation Process:
    [[http://ais.nci.nih.gov/]{.underline}](http://ais.nci.nih.gov/)

11. NIH Systems Security Plan Template (detailed):
    [[http://irm.cit.nih.gov/security/secplantemp.doc]{.underline}](http://irm.cit.nih.gov/security/secplantemp.doc)

12. NIH Systems Security Plan Outline (outline only):
    [[http://irm.cit.nih.gov/nihsecurity/Security_Plan_Outline.doc]{.underline}](http://irm.cit.nih.gov/nihsecurity/Security_Plan_Outline.doc)

13. NIH Information Technology General Rules of Behavior:
    [[http://irm.cit.nih.gov/security/nihitrob.html]{.underline}](http://irm.cit.nih.gov/security/nihitrob.html)

14. Commitment To Protect Non-Public Information - Contractor Agreement:

[[http://irm.cit.nih.gov/security/Nondisclosure.pdf]{.underline}](http://irm.cit.nih.gov/security/Nondisclosure.pdf)

[]{#__RefHeading___Toc124312162 .anchor}ARTICLE H.17. ENERGY STAR
REQUIREMENTS

Executive Order 13123, "Greening the Government Through Efficient Energy
Management" and FAR 23.203 require that when Federal Agencies acquire
energy using products, they select, where life-cycle cost-effective, and
available, ENERGY STAR® or other energy efficient products.

Unless the Contracting Officer determines otherwise, all energy-using
products acquired under this contract must be either an ENERGY STAR® or
other energy efficient product designated by the Department of Energy's
Federal Energy Management Program (FEMP).

For more information about ENERGY STAR® see
[[http://www.energystar.gov/]{.underline}](http://www.energystar.gov/)

For more information about FEMP see
[[http://www.eere.energy.gov/]{.underline}](http://www.eere.energy.gov/)

[]{#__RefHeading___Toc124312163 .anchor}ARTICLE H.18. PUBLICATION AND
PUBLICITY

The contractor shall acknowledge the support of the National Institutes
of Health whenever publicizing the work under this contract in any media
by including an acknowledgment substantially as follows:

> \"This project has been funded in whole or in part with Federal funds
> from the National Institute for Allergy and Infectious Diseases,
> National Institutes of Health, Department of Health and Human
> Services, under Contract No. .

[]{#__RefHeading___Toc124312164 .anchor}ARTICLE H.19. PRESS RELEASES

a\. Pursuant to Public Law(s) cited in paragraph b., below, the
contractor shall clearly state, when issuing statements, press releases,
requests for proposals, bid solicitations and other documents describing
projects or programs funded in whole or in part with Federal money: (1)
the percentage of the total costs of the program or project which will
be financed with Federal money; (2) the dollar amount of Federal funds
for the project or program; and (3) the percentage and dollar amount of
the total costs of the project or program that will be financed by
nongovernmental sources.

+----------------------+------------------+---------------------------+
| b\. **Public Law and | **Fiscal Year**  | > **Period Covered**      |
| Section No.**        |                  |                           |
+----------------------+------------------+---------------------------+

\[Applicable information to be included at award\]

[]{#__RefHeading___Toc124312165 .anchor}ARTICLE H.20 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

[]{#refheading___toc124312166 .anchor}ARTICLE H.21. YEAR 2000 COMPLIANCE

In accordance with FAR 39.106, Information Technology acquired under
this contract must be Year 2000 compliant as set forth in the following
clause(s):

1\. Service Involving the Use of Information Technology

> **YEAR 2000 COMPLIANCE\--SERVICE INVOLVING THE USE OF INFORMATION
> TECHNOLOGY**
>
> The Contractor agrees that each item of hardware, software, and
> firmware used under this contract shall be able to accurately process
> date data (including, but not limited to, calculating, comparing and
> sequencing) from, into and between the twentieth and twenty-first
> centuries and the Year 1999 and the Year 2000 and leap year
> calculations.

(End of Clause)

2\. Noncommercial Supply Items Warranty

> **YEAR 2000 WARRANTY\--NONCOMMERCIAL SUPPLY ITEMS**
>
> The contractor warrants that each noncommercial item of hardware,
> software, and firmware delivered or developed under this contract and
> listed below shall be able to accurately process date data (including,
> but not limited to, calculating, comparing and sequencing) from, into
> and between the twentieth and twenty-first centuries and the Year 1999
> and the Year 2000 and leap year calculations, when used in accordance
> with the item documentation provided by the contractor, provided that
> all listed or unlisted items (e.g., hardware, software and firmware)
> used in combination with such listed item properly exchange date data
> with it. If the contract requires that specific listed items must
> perform as a system in accordance with the foregoing warranty, then
> that warranty shall apply to those listed items as a system. The
> duration of this warranty and the remedies available to the Government
> for breach of this warranty shall be as defined in, and subject to,
> the terms and limitations of any general warranty provisions of this
> contract provided that notwithstanding any provision to the contrary
> in such warranty provision(s), or in the absence of any such warranty
> provision(s), the remedies available to the Government under this
> warranty shall include repair or replacement of any listed item whose
> noncompliance is discovered and made known to the contractor in
> writing within ninety (90) days after acceptance. Nothing in this
> warranty shall be construed to limit any rights or remedies the
> Government may otherwise have under this contract with respect to
> defects other than Year 2000 performance.

**YEAR 2000 COMPLIANT ITEMS**

[To be identified at the time of award]{.underline}

(End of Clause)

3\. Commercial Supply Products Warranty

> **YEAR 2000 WARRANTY\--COMMERCIAL SUPPLY ITEMS**
>
> The contractor warrants that each hardware, software and firmware
> product delivered under this contract and listed below shall be able
> to accurately process date data (including, but not limited to,
> calculating, comparing, and sequencing) from, into, and between the
> twentieth and twenty-first centuries and the Year 1999 and the Year
> 2000 and leap year calculations, when used in accordance with the
> product documentation provided by the contractor, provided that all
> listed or unlisted products (e.g., hardware, software, firmware) used
> in combination with such listed product properly exchange date data
> with it. If the contract requires that specific listed products must
> perform as a system in accordance with the foregoing warranty, then
> that warranty shall apply to those listed products as a system. The
> duration of this warranty and the remedies available to the Government
> for breach of this warranty shall be as defined in, and subject to,
> the terms and limitations of the contractor\'s standard commercial
> warranty or warranties contained in this contract, provided that
> notwithstanding any provision to the contrary in such commercial
> warranty or warranties, the remedies available to the Government under
> this warranty shall include repair or replacement of any listed
> product whose non-compliance is discovered and made known to the
> contractor in writing within ninety (90) days after acceptance.
> Nothing in this warranty shall be construed to limit any rights or
> remedies the Government may otherwise have under this contract with
> respect to defects other than Year 2000 performance.

**YEAR 2000 COMPLIANT ITEMS**

[To be identified at the time of contract award]{.underline}

(End of Clause)

[]{#__RefHeading___Toc124312167 .anchor}ARTICLE H.22. ANTI -LOBBYING

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

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

+-----------------------+-----------------+---------------------------+
| c\. **Public Law and  | **Fiscal Year** | > **Period Covered**      |
| Section No.**         |                 |                           |
+-----------------------+-----------------+---------------------------+

\[Applicable information to be included at award\]

[]{#__RefHeading___Toc124312168 .anchor}ARTICLE H. 23. LIMITATION ON USE
OF FUNDS FOR PROMOTION OF LEGALIZATION OF CONTROLLED SUBSTANCES

a\. Pursuant to Public Laws(s) cited in paragraph b., above, contract
funds shall not be used to support activities that promote the
legalization of any drug or other substance included in schedule I of
the schedules of controlled substances established by section 202 of the
Controlled Substances Act (21 U.S.C. 812). This limitation shall not
apply when the contractor makes known to the contracting officer that
there is significant medical evidence of a therapeutic advantage to the
use of such drug or other substance or that federally sponsored clinical
trials are being conducted to determine therapeutic advantage.

+-----------------------+-----------------+---------------------------+
| b\. **Public Law and  | **Fiscal Year** | > **Period Covered**      |
| Section No.**         |                 |                           |
+-----------------------+-----------------+---------------------------+

\[Applicable information to be included at award\]

[]{#__RefHeading___Toc124312169 .anchor}ARTICLE H.24. SHARING RESEARCH
DATA

\[The data sharing plan submitted by the contractor is acceptable/The
contractor\'s data sharing plan, dated is hereby incorporated by
reference.\] The contractor agrees to adhere to its plan and shall
request prior approval of the Contracting Officer for any changes in its
plan.

The NIH endorses the sharing of final research data to expedite the
translation of research results into knowledge, products, and procedures
to improve human health. This contract is expected to generate research
data that must be shared with the public and other researchers. NIH\'s
data sharing policy may be found at the following Web site:

[[http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html)

NIH recognizes that data sharing may be complicated or limited, in some
cases, by institutional policies, local IRB rules, as well as local,
state and Federal laws and regulations, including the Privacy Rule (see
HHS-published documentation on the Privacy Rule at
[[http://www.hhs.gov/ocr/]{.underline}](http://www.hhs.gov/ocr/)). The
rights and privacy of people who participate in NIH-funded research must
be protected at all times; thus, data intended for broader use should be
free of identifiers that would permit linkages to individual research
participants and variables that could lead to deductive disclosure of
the identity of individual subjects.

[]{#__RefHeading___Toc124312170 .anchor}ARTICLE H.25. POSSESSION USE AND
TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

The contractor shall not conduct work involving select agents or toxins
under this contract until it and any associated subcontractor(s) comply
with the following:

> For prime or subcontract awards to ***domestic institutions*** that
> possess, use, and/or transfer Select Agents under this contract, the
> institution must comply with the provisions of 42 CFR part 73, 7 CFR
> part 331, and/or 9 CFR part 121
> ([[http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf]{.underline}](http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf)),
> as required, before using NIH funds for research involving Select
> Agents. No NIH funds can be used for research involving Select Agents
> if the final registration certificate is denied.
>
> For prime or subcontract awards to ***foreign institutions*** that
> possess, use, and/or transfer Select Agents under this contract,
> before using NIH funds for any work directly involving the Select
> Agents, the foreign institution must provide information satisfactory
> to the NIAID, NIH that safety, security, and training standards
> equivalent to those described in 42 CFR part 73, 7 CFR part 331,
> and/or 9 CFR part 121 at:

([[http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf]{.underline}](http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf))

> are in place and will be administered on behalf of all Select Agent
> work sponsored by these funds. The process for making this
> determination includes inspection of the foreign laboratory facility
> by an NIAID representative. During this inspection, the foreign
> institution must provide the following information: concise summaries
> of safety, security, and training plans; names of individuals at the
> foreign institution who will have access to the Select Agents and
> procedures for ensuring that only approved and appropriate
> individuals, in accordance with institution procedures, will have
> access to the Select Agents under the contract; and copies of or links
> to any applicable laws, regulations, policies, and procedures
> applicable to that institution for the safe and secure possession,
> use, and/or transfer of select agents. An NIAID-chaired committee of
> U.S. federal employees (including representatives of NIH
> grants/contracts and scientific program management, CDC, Department of
> Justice and other federal intelligence agencies, and Department of
> State) will ultimately assess the results of the laboratory facility
> inspection, and the regulations, policies, and procedures of the
> foreign institution for equivalence to the U.S. requirements described
> in 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121
> ([[http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf]{.underline}](http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf)).
> The committee will provide recommendations to the DEA Director, NIAID.
> The DEA Director will make the approval decision and notify the
> Contracting Officer. The Contracting Officer will inform the prime
> contractor of the approval status of the foreign institution. No NIH
> funds can be used for research involving Select Agents at a foreign
> institution until NIAID grants this approval.

Listings of HHS select agents and toxins, and overlap select agents or
toxins as well as information about the registration process for
domestic institutions, are available on the Select Agent Program Web
site at
[[http://www.cdc.gov/od/sap/]{.underline}](http://www.cdc.gov/od/sap/)
and
[[http://www.cdc.gov/od/sap/docs/salist.pdf]{.underline}](http://www.cdc.gov/od/sap/docs/salist.pdf).
Listings of USDA select agents and toxins as well as information about
the registration process for domestic institutions are available on the
APHIS/USDA website at
[[http://www.aphis.usda.gov/programs/ag_selectagent/index.html]{.underline}](http://www.aphis.usda.gov/programs/ag_selectagent/index.html)
and
[[http://www.aphis.usda.gov/programs/ag_selectagent/ag_bioterr_forms.html]{.underline}](http://www.aphis.usda.gov/programs/ag_selectagent/ag_bioterr_forms.html).
For foreign institutions, see the NIAID Select Agent Award information
([[http://www.niaid.nih.gov/ncn/clinical/default_biodefense.htm]{.underline}](http://www.niaid.nih.gov/ncn/clinical/default_biodefense.htm)).

[]{#h26HOTEL .anchor}

**ARTICLE H.26. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)**

Pursuant to Public Law 101-391, no Federal funds may be used to sponsor
or fund in whole or in part a meeting, convention, conference or
training seminar that is conducted in, or that otherwise uses the rooms,
facilities, or services of a place of public accommodation that do not
meet the requirements of the fire prevention and control guidelines as
described in the Public Law. This restriction applies to public
accommodations both foreign and domestic.

Public accommodations that meet the requirements can be accessed at:
[[http://www.usfa.fema.gov/hotel/index.htm]{.underline}](http://www.usfa.fema.gov/hotel/index.htm)

**ARTICLE H.27. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST
ACTIVITIES**

The contractor acknowledges that U.S. Executive Orders and Laws,
including but not limited to E.O. 13224 and P.L. 107-56, prohibit
transactions with, and the provision of resources and support to,
individuals and organizations associated with terrorism. It is the legal
responsibility of the contractor to ensure compliance with these
Executive Orders and Laws. This clause must be included in all
subcontracts issued under this contract.

[]{#__RefHeading___Toc124312171 .anchor}ARTICLE H.28. NIH POLICY ON
ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM
NIH-FUNDED RESEARCH

The Policy requests that beginning May 2, 2005, NIH-funded investigators
submit to the NIH National Library of Medicine's (NLM) PubMed Central
(PMC) an electronic version of the author's final manuscript, upon
acceptance for publication, resulting from research supported in whole
or in part with direct costs from NIH. NIH defines the author's final
manuscript as the final version accepted for journal publication, and
includes all modifications from the publishing peer review process. The
PMC archive will preserve permanently these manuscripts for use by the
public, health care providers, educators, scientists, and NIH. The
Policy directs electronic submissions to the NIH/NLM/PMC:
[[http://www.pubmedcentral.nih.gov]{.underline}](http://www.pubmedcentral.nih.gov/).

Additional information is available at
[[http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html).

[]{#__RefHeading___Toc124312172 .anchor}ARTICLE H.29. CONSTITUTION DAY

Each educational institutional institution that receives Federal funds
for a fiscal year shall hold an educational program on the United States
Constitution on September 17 of such year for the students serviced by
the educational institution in accordance with Public Law 108-447.

**ARTICLE H.30. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH
RESOURCES**

[]{#H30biomedresources .anchor}Unique research resources arising from
NIH-funded research are to be shared with the scientific research
community. NIH provides guidance, entitled, "Sharing Biomedical Research
Resources: Principles and Guidelines for Recipients of NIH Research
Grants and Contracts," (Federal Register Notice, December 23, 1999 \[64
FR 72090\]), concerning the appropriate terms for disseminating and
acquiring these research resources. This guidance, found at : . is
intended to help contractors ensure that the conditions they impose and
accept on the transfer of research tools will facilitate further
biomedical research, consistent with the requirements of the Bayh-Dole
Act and NIH funding policy.

*Note: For the purposes of this Article, the terms, \"research tools,\"
\"research materials,\" and \"research resources\" are used
interchangeably and have the same meaning*

[]{#__RefHeading___Toc124312173 .anchor}PART II - CONTRACT CLAUSES

[]{#__RefHeading___Toc124312174 .anchor}SECTION I - CONTRACT CLAUSES

THE FOLLOWING **ARTICLE I.1 GENERAL CLAUSE LISTING(S)** 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/appl/general-clauses/clauses.jsp]{.underline}](http://rcb.cancer.gov/rcb-internet/appl/general-clauses/clauses.jsp)

[]{#__RefHeading___Toc124312175 .anchor}ARTICLE I.2. AUTHORIZED
SUBSTITUTIONS OF CLAUSES

Any authorized substitutions and/or modifications other than the General
Clauses which will be based on the type of contract/Contractor will be
determined during negotiations.

It is expected that the following clause(s) will be made part of the
resultant contract:

**Alternate IV** (October 1997) of FAR Clause **52.215-21, Requirements
For Cost Or Pricing Data Or Information Other Than Cost Or Pricing
Data---Modifications**

**Alternate II** (October 2001) of FAR Clause **52.219-9, Small Business
Subcontracting Plan** (January 2002) is added.

**ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES**

Additional clauses other than those listed below which are based on the
type of contract/Contractor shall be determined during negotiations. Any
contract awarded from this solicitation will contain the following:

This contract incorporates the following clauses 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.

a\. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

\(1\) FAR Clause **52.217-8, Option to Extend Services (November 1999)**

\"\....The Contracting Officer may exercise the option by written notice
to the Contractor within 30 days"

\(2\) FAR Clause **52.219-4, Notice of Price Evaluation Preference for
HUBZone Small Business Concerns** (July 2005).

\"(c) Waiver of evaluation preference\.....

**\[ \]** Offeror elects to waive the evaluation preference.\"

\(3\) FAR Clause **52.223-12, Refrigeration Equipment and Air
Conditioners** (May 1995).

\(4\) FAR Clause **52.224-1, Privacy Act Notification** (April 1984).

\(5\) FAR Clause **52.224-2, Privacy Act** (April 1984).

6.  FAR Clause **52.227-2,** Notice & Assistance Regarding Patent
    &Copyright Infringement

```{=html}
<!-- -->
```
7.  FAR Clause **52.227-6,** Royalty Information

8.  **Alternate I** (June 1987), FAR Clause **52.227-14, Rights in
    Data\--General** (June 1987).

\(9\) **Alternate III** (June 1987), FAR Clause **52.227-14, Rights in
Data\--General** (June 1987).

> Additions to, or limitations on, the restricted rights set forth in
> the Restricted Rights Notice of subparagraph (g)(3) of the clause are
> expressly stated as follows: NONE.

\(10\) FAR Clause **52.227-16, Additional Data Requirements** (June
1987).

\(11\) FAR Clause **52.239-1, Privacy or Security Safeguards** (August
1996)

\(12\) FAR Clause **52.242-3, Penalties for Unallowable Costs** (May
2001).

\(13\) FAR Clause **52.243-2, Changes\--Cost Reimbursement** (August
1987), **Alternate V** (April 1984).

\(14\) FAR Clause **52.246-23, Limitation of Liability** (February
1997).

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

\(1\) HHSAR Clause **352.223-70, Safety and Health** (January 2001).

\(2\) HHSAR 352.224-70, Confidentiality of Information (APRIL 1984 --
including revisions mandated by the 1/3/2005 Register notice which was
effective March 2005).

\(3\) HHSAR Clause **352.270-1, Accessibility of Meetings, Conferences
and Seminars to Persons with Disabilities** (January 2001).

\(4\) HHSAR Clause **352.270-8, Protection of Human Subjects** (March
2005).

5.  HHSAR Clause **352.270-9, Care of Live Vertebrate Animals** (March
    2005).

6.  HHSAR Clause **352.333-7001, Choice of Law (Overseas)** (March 2005)

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

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

\(1\) **NIH (RC)-7, Procurement of Certain Equipment** (April 1984)

\(2\) **NIH(RC)-11, Research Patient Care Costs** (4/1/84).

[]{#__RefHeading___Toc124312176 .anchor}ARTICLE I.4. ADDITIONAL FAR
CONTRACT CLAUSES INCLUDED IN FULL TEXT

Additional clauses other than those listed below which are based on the
type of contract/Contractor shall be determined during negotiations. Any
contract awarded from this solicitation will contain the following:

This contract incorporates the following clauses in full text.

FEDERAL ACQUISITION REGULATION (FAR)(48 CFR CHAPTER 1) CLAUSES:

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

\(a\) Definition. As used in this clause\--

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

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

Notice to Employees

Under Federal law, employees cannot be required to join a union or
maintain membership in a union in order to retain their jobs. Under
certain conditions, the law permits a union and an employer to enter
into a union-security agreement requiring employees to pay uniform
periodic dues and initiation fees. However, employees who are not union
members can object to the use of their payments for certain purposes and
can only be required to pay their share of union costs relating to
collective bargaining, contract administration, and grievance
adjustment.

If you do not want to pay that portion of dues or fees used to support
activities not related to collective bargaining, contract
administration, or grievance adjustment, you are entitled to an
appropriate reduction in your payment. If you believe that you have been
required to pay dues or fees used in part to support activities not
related to collective bargaining, contract administration, or grievance
adjustment, you may be entitled to a refund and to an appropriate
reduction in future payments.

For further information concerning your rights, you may wish to contact
the National Labor Relations Board (NLRB) either at one of its Regional
offices or at the following address or toll free number:

National Labor Relations Board

Division of Information

1099 14th Street, N.W.

Washington, DC 20570

1-866-667-6572

1-866-316-6572 (TTY)

To locate the nearest NLRB office, see NLRB\'s website at
[[http://www.nlrb.gov]{.underline}](http://www.nlrb.gov/).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[]{#__RefHeading___Toc124312177 .anchor}PART III - LIST OF DOCUMENTS,
EXHIBITS AND OTHER ATTACHMENTS

[]{#__RefHeading___Toc124312178 .anchor}SECTION J - LIST OF ATTACHMENTS

The following documents are incorporated into this RFP:

**SOLICITATION ATTACHMENTS:**

+----------+-----------------------------+-----------------------------+
| **At     | **Title**                   | **Location**                |
| tachment |                             |                             |
| No.**    |                             |                             |
+----------+-----------------------------+-----------------------------+
| At       | Packaging and Delivery of   | <http://www.niaid.nih.      |
| tachment | Proposal                    | gov/contract/eproposal.htm> |
| 1:       |                             |                             |
+----------+-----------------------------+-----------------------------+
| At       | Proposal Intent Response    | [See Attachment Section at  |
| tachment | Sheet                       | the end of this             |
| 2:       |                             | RFP](#proposalintent)       |
+----------+-----------------------------+-----------------------------+
| At       | Statement of Work           | [See Attachment Section at  |
| tachment |                             | the end of this RFP](#SOW)  |
| 3:       |                             |                             |
+----------+-----------------------------+-----------------------------+
| At       | Information Technology      | [[http://rcb.cancer.gov     |
| tachment | Systems Security -          | /rcb-internet/forms/IT-secu |
| 4:       | Prospective Offeror         | rity-nondisclosure.pdf]{.un |
|          | Non-Disclosure Agreement    | derline}](http://rcb.cancer |
|          |                             | .gov/rcb-internet/forms/IT- |
|          |                             | security-nondisclosure.pdf) |
+----------+-----------------------------+-----------------------------+
| At       | Appendix A                  | [See Attachment Section at  |
| tachment |                             | the end of this             |
| 5:       | Additional Technical        | RFP](#APPENDIXA)            |
|          | Proposal instructions       |                             |
+----------+-----------------------------+-----------------------------+
| At       | Appendix B                  | [See Attachment Section at  |
| tachment |                             | the end of this             |
| 6:       | Additional Business         | RFP](#APPENDIXB)            |
|          | Proposal Instructions       |                             |
|          | (Uniform Assumptions)       |                             |
+----------+-----------------------------+-----------------------------+

**TECHNICAL PROPOSAL ATTACHMENTS:** (The following attachments must be
completed, where applicable, and submitted with the Technical Proposal.)

  -------------- ---------------------------- --------------------------------------------------------------------------------------------------------------------------------------
  **Attachment   **Title**                    **Location**
  No.**                                       

  Attachment 7:  Targeted/Planned Enrollment  [[http://rcb.cancer.gov/rcb-internet/forms/enroll-table.pdf]{.underline}](http://rcb.cancer.gov/rcb-internet/forms/enroll-table.pdf)
                 Table                        

  Attachment 8:  Annual Technical Progress    [[http://rcb.cancer.gov/rcb-internet/forms/atpr.pdf]{.underline}](http://rcb.cancer.gov/rcb-internet/forms/atpr.pdf)
                 Report Format for Each Study 

  Attachment 9:  Technical Proposal Cost      [[http://www.niaid.nih.gov/contract/forms.htm]{.underline}](http://www.niaid.nih.gov/contract/forms.htm)
                 Summary                      

  Attachment 10: Summary of Related           [[http://www.niaid.nih.gov/contract/forms.htm]{.underline}](http://www.niaid.nih.gov/contract/forms.htm)
                 Activities                   

  Attachment 11: Government Notice for        [[http://www.niaid.nih.gov/contract/forms/form7.pdf]{.underline}](http://www.niaid.nih.gov/contract/forms/form7.pdf)
                 Handling Proposals           

  Attachment 12: Protection of Human Subjects [[http://rcb.cancer.gov/rcb-internet/forms/of310.pdf]{.underline}](http://rcb.cancer.gov/rcb-internet/forms/of310.pdf)
                 Assurance Identification/IRB 
                 Certification/Declaration of 
                 Exemption, OMB Form No.      
                 0990-0263 (formerly Optional 
                 Form 310                     

  Attachment 13: Project Objectives, NIH      [[http://rcb.cancer.gov/rcb-internet/forms/nih1688-1.pdf]{.underline}](http://rcb.cancer.gov/rcb-internet/forms/nih1688-1.pdf)
                 1688-1                       
  -------------- ---------------------------- --------------------------------------------------------------------------------------------------------------------------------------

**BUSINESS PROPOSAL ATTACHMENTS:** (The following attachments must be
completed, where applicable, and submitted with the Business Proposal.)

+-----------+----------------------------+-----------------------------+
| **A       | **Title**                  | **Location**                |
| ttachment |                            |                             |
| No.**     |                            |                             |
+-----------+----------------------------+-----------------------------+
| A         | Proposal Summary and Data  | [[http://www.niaid.nih.     |
| ttachment | Record,                    | gov/contract/forms.htm]{.un |
| 14:       |                            | derline}](http://www.niaid. |
|           | NIH-2043                   | nih.gov/contract/forms.htm) |
+-----------+----------------------------+-----------------------------+
| A         | Small Business             | [                           |
| ttachment | Subcontracting Plan        | [http://rcb.cancer.gov/rcb- |
| 15:       |                            | internet/forms/sb-subplan-n |
|           |                            | ci.pdf]{.underline}](http:/ |
|           |                            | /rcb.cancer.gov/rcb-interne |
|           |                            | t/forms/sb-subplan-nci.pdf) |
+-----------+----------------------------+-----------------------------+
| A         | Breakdown of Proposed      | [[http://www.niaid.nih.     |
| ttachment | Estimated Costs (plus Fee) | gov/contract/forms.htm]{.un |
| 16:       | with Excel Spreadsheet     | derline}](http://www.niaid. |
|           |                            | nih.gov/contract/forms.htm) |
|           |                            |                             |
|           |                            | [[http:/                    |
|           |                            | /ocm.od.nih.gov/contracts/s |
|           |                            | psh/spshexcl.xls]{.underlin |
|           |                            | e}](http://ocm.od.nih.gov/c |
|           |                            | ontracts/spsh/spshexcl.xls) |
+-----------+----------------------------+-----------------------------+
| A         | Offeror\'s Points of       | [[http://www.niaid.nih.     |
| ttachment | Contact                    | gov/contract/forms.htm]{.un |
| 17:       |                            | derline}](http://www.niaid. |
|           |                            | nih.gov/contract/forms.htm) |
+-----------+----------------------------+-----------------------------+
| A         | Disclosure of Lobbying     | [[http://rcb.c              |
| ttachment | Activities, OMB Form       | ancer.gov/rcb-internet/form |
| 18:       | SF-LLL                     | s/sflllin.pdf]{.underline}] |
|           |                            | (http://rcb.cancer.gov/rcb- |
|           |                            | internet/forms/sflllin.pdf) |
+-----------+----------------------------+-----------------------------+

**INFORMATIONAL ATTACHMENTS:** (The following Attachments and Reports
will become part of any contract resulting from this RFP and will be
required during contract performance.)

+-----------+----------------------------+-----------------------------+
| **A       | **Title**                  | **Location**                |
| ttachment |                            |                             |
| No.**     |                            |                             |
+-----------+----------------------------+-----------------------------+
| A         | Invoice/Financing Request  | [[http                      |
| ttachment | Instruct                   | ://rcb.cancer.gov/rcb-inter |
| 19:       | ions\--Cost-Reimbursement, | net/forms/rc1.pdf]{.underli |
|           | NIH(RC)-1                  | ne}](http://rcb.cancer.gov/ |
|           |                            | rcb-internet/forms/rc1.pdf) |
+-----------+----------------------------+-----------------------------+
| A         | Invoice/Financing Request  | [[http                      |
| ttachment | and Contract Financial     | ://rcb.cancer.gov/rcb-inter |
| 20:       | Reporting                  | net/forms/rc4.pdf]{.underli |
|           | Instructions\--Cost        | ne}](http://rcb.cancer.gov/ |
|           | Reimbursement, NIH(RC)-4   | rcb-internet/forms/rc4.pdf) |
+-----------+----------------------------+-----------------------------+
| A         | Financial Report of        | [[http://www.n              |
| ttachment | Individual                 | iaid.nih.gov/contract/forms |
| 21:       | Project/Contract, NIH 2706 | /nih-2706.pdf]{.underline}] |
|           |                            | (http://www.niaid.nih.gov/c |
|           |                            | ontract/forms/nih-2706.pdf) |
+-----------+----------------------------+-----------------------------+
| A         | Instructions for           | [[h                         |
| ttachment | Completing Form NIH 2706   | ttp://www.niaid.nih.gov/con |
| 22:       |                            | tract/forms/instructions270 |
|           |                            | 6.pdf]{.underline}](http:// |
|           |                            | www.niaid.nih.gov/contract/ |
|           |                            | forms/instructions2706.pdf) |
+-----------+----------------------------+-----------------------------+
| A         | Privacy Act System of      | [                           |
| ttachment | Records                    | [http://oma.od.nih.gov/ms/p |
| 23:       |                            | rivacy/pa-files/read02syste |
|           | > *System of Records       | ms.htm]{.underline}](http:/ |
|           | > No.09-25-0200 is         | /oma.od.nih.gov/ms/privacy/ |
|           | > applicable to this RFP.* | pa-files/read02systems.htm) |
+-----------+----------------------------+-----------------------------+
| A         | Safety and Health, HHSAR   | [[http://w                  |
| ttachment | Clause 352.223-70          | ww.niaid.nih.gov/contract/f |
| 24:       |                            | orms/form10.pdf]{.underline |
|           |                            | }](http://www.niaid.nih.gov |
|           |                            | /contract/forms/form10.pdf) |
+-----------+----------------------------+-----------------------------+
| A         | Procurement of Certain     | [[http://www.n              |
| ttachment | Equipment, NIH(RC)-7       | iaid.nih.gov/contract/forms |
| 25:       |                            | /NIH-RC-7.pdf]{.underline}] |
|           |                            | (http://www.niaid.nih.gov/c |
|           |                            | ontract/forms/NIH-RC-7.pdf) |
+-----------+----------------------------+-----------------------------+
| A         | Research Patient Care      | [[http://www.nia            |
| ttachment | Costs, NIH(RC)-11          | id.nih.gov/contract/forms/n |
| 26:       |                            | ih-rc-11.pdf]{.underline}]( |
|           |                            | http://www.niaid.nih.gov/co |
|           |                            | ntract/forms/nih-rc-11.pdf) |
+-----------+----------------------------+-----------------------------+
| A         | Inclusion Enrollment       | [[http://rcb.               |
| ttachment | Report                     | cancer.gov/rcb-internet/for |
| 27:       |                            | ms/inclusion-enrollment.pdf |
|           |                            | ]{.underline}](http://rcb.c |
|           |                            | ancer.gov/rcb-internet/form |
|           |                            | s/inclusion-enrollment.pdf) |
+-----------+----------------------------+-----------------------------+
| A         | Employee Separation        | [[http:                     |
| ttachment | Checklist                  | //rcb.cancer.gov/rcb-intern |
| 28:       |                            | et/forms/Emp-sep-checklist. |
|           |                            | pdf]{.underline}](http://rc |
|           |                            | b.cancer.gov/rcb-internet/f |
|           |                            | orms/Emp-sep-checklist.pdf) |
+-----------+----------------------------+-----------------------------+
| A         | Government Property        | [See Attachment Section at  |
| ttachment | Schedule                   | the end of this             |
| 29:       |                            | RFP](#govtproperty)         |
+-----------+----------------------------+-----------------------------+
| A         | Commitment To Protect      | [[http:/                    |
| ttachment | Non-Public Information     | /irm.cit.nih.gov/security/N |
| 30:       | Contractor Agreement       | ondisclosure.pdf]{.underlin |
|           |                            | e}](http://irm.cit.nih.gov/ |
|           |                            | security/Nondisclosure.pdf) |
+-----------+----------------------------+-----------------------------+
| A         | Roster of Employees        | [[http://ais                |
| ttachment | Requiring Suitability      | .nci.nih.gov/forms/Suitabil |
| 31:       | Investigations             | ity-roster.xls]{.underline} |
|           |                            | ](http://ais.nci.nih.gov/fo |
|           |                            | rms/Suitability-roster.xls) |
+-----------+----------------------------+-----------------------------+

Immune Tolerance Network Informational Appendices

+-----------------------+-----------------------+-----------------------+
| **Attachment No.**    | **Title**             | **Location**          |
+-----------------------+-----------------------+-----------------------+
| Attachment 32:        | Appendix C            | [See Attachment       |
|                       |                       | Section at end of     |
|                       | Ongoing ITN Clinical  | this RFP](#AppendixC) |
|                       | Trials and Tolerance  |                       |
|                       | Assay Studies         |                       |
+-----------------------+-----------------------+-----------------------+
| Attachment 33:        | Appendix D            | [See Attachment       |
|                       |                       | Section at end of     |
|                       | ITN Core Facilities   | this RFP](#AppendixD) |
|                       | and Laboratories      |                       |
+-----------------------+-----------------------+-----------------------+
| Attachment 34:        | Appendix E            | [See Attachment       |
|                       |                       | Section at end of     |
|                       | NIAID-Funded Clinical | this RFP](#APPENDIXE) |
|                       | Research Support      |                       |
|                       | Services              |                       |
+-----------------------+-----------------------+-----------------------+
| Attachment 35:        | Appendix F            | [See Attachment       |
|                       |                       | Section at end of     |
|                       | NIH Funded Clinical   | this RF](#APPENDIXF)P |
|                       | Research Programs     |                       |
+-----------------------+-----------------------+-----------------------+
| Attachment 36:        | Appendix G            | [See Attachment       |
|                       |                       | Section at end of     |
|                       | Internet Sites for    | this RFP](#APPENDIXG) |
|                       | ITN and RFP           |                       |
+-----------------------+-----------------------+-----------------------+
| Attachment 37         | Contractor Request to | [See Attachment       |
|                       | Subcontract Checklist | Section at end of     |
|                       |                       | this                  |
|                       |                       | RFP](#subKchecklist)  |
+-----------------------+-----------------------+-----------------------+

[]{#__RefHeading___Toc124312179 .anchor}PART IV - REPRESENTATIONS AND
INSTRUCTIONS

[]{#__RefHeading___Toc124312180 .anchor}SECTION K - REPRESENTATIONS,
CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION K can be accessed electronically from the INTERNET at the
following address:

[[http://rcb.cancer.gov/rcb-internet/wkf/sectionk.pdf]{.underline}](http://rcb.cancer.gov/rcb-internet/wkf/sectionk.pdf)

If you are unable to access this document electronically, you may
request a copy from the Contracting Officer identified on the cover page
of this solicitation.

**IF YOU INTEND TO SUBMIT A PROPOSAL, YOU [MUST]{.underline} COMPLETE
SECTION K AND SUBMIT IT AS PART OF YOUR BUSINESS PROPOSAL.**

[]{#__RefHeading___Toc124312181 .anchor}SECTION L - INSTRUCTIONS,
CONDITIONS AND NOTICES TO OFFERORS

1\. GENERAL []{#lGENERALINFO .anchor}INFORMATION

a.  **INSTRUCTIONS TO OFFERORS\--COMPETITIVE ACQUISITION** \[FAR
    Provision 52.215-1 (January 2004)\]

\(1\) *Definitions*. As used in this provision\--

*Discussions* are negotiations that occur after establishment of the
competitive range that may, at the Contracting Officer\'s discretion,
result in the offeror being allowed to revise its proposal.

*\"In writing\"*, *\"writing\"*, or *\"written\"* means any worded or
numbered expression that can be read, reproduced, and later
communicated, and includes electronically transmitted and stored
information.

\"*Proposal modification*\" is a change made to a proposal before the
solicitation\'s closing date and time, or made in response to an
amendment, or made to correct a mistake at any time before award.

\"*Proposal revision*\" is a change to a proposal made after the
solicitation closing date, at the request of or as allowed by a
Contracting Officer as the result of negotiations.

\"*Time,*\" if stated as a number of days, is calculated using calendar
days, unless otherwise specified, and will include Saturdays, Sundays,
and legal holidays. However, if the last day falls on a Saturday,
Sunday, or legal holiday, then the period shall include the next working
day.

\(2\) *Amendments to solicitations*. If this solicitation is amended,
all terms and conditions that are not amended remain unchanged. Offerors
shall acknowledge receipt of any amendment to this solicitation by the
date and time specified in the amendment(s).

\(3\) *Submission, modification, revision, and withdrawal of proposals*.
(1) Unless other methods (*e.g.*, electronic commerce or facsimile) are
permitted in the solicitation, proposals and modifications to proposals
shall be submitted in paper media in sealed envelopes or packages (i)
addressed to the office specified in the solicitation, and (ii) showing
the time and date specified for receipt, the solicitation number, and
the name and address of the offeror. Offerors using commercial carriers
should ensure that the proposal is marked on the outermost wrapper with
the information in paragraphs (c)(1)(i) and (c)(1)(ii) of this
provision.

\(a\) The first page of the proposal must show\--

1\. The solicitation number;

2\. The name, address, and telephone and facsimile numbers of the
offeror (and electronic address if available);

3\. A statement specifying the extent of agreement with all terms,
conditions, and provisions included in the solicitation and agreement to
furnish any or all items upon which prices are offered at the price set
opposite each item;

4\. Names, titles, and telephone and facsimile numbers (and electronic
addresses if available) of persons authorized to negotiate on the
offeror\'s behalf with the Government in connection with this
solicitation; and

5\. Name, title, and signature of person authorized to sign the
proposal. Proposals signed by an agent shall be accompanied by evidence
of that agent\'s authority, unless that evidence has been previously
furnished to the issuing office.

\(4\) *Submission, modification, revision, and withdrawal of proposals*.
(i) Offerors are responsible for submitting proposals, and any
modifications or revisions, so as to reach the Government office
designated in the solicitation by the time specified in the
solicitation. If no time is specified in the solicitation, the time for
receipt is 4:30 p.m., local time, for the designated Government office
on the date that proposal or revision is due.

\(a\) Any proposal, modification, or revision received at the Government
office designated in the solicitation after the exact time specified for
receipt of offers is \"late\" and will not be considered unless it is
received before award is made, the Contracting Officer determines that
accepting the late offer would not unduly delay the acquisition; and\--

1\. If it was transmitted through an electronic commerce method
authorized by the solicitation, it was received at the initial point of
entry to the Government infrastructure not later than 5:00 p.m. one
working day prior to the date specified for receipt of proposals; or

2\. There is acceptable evidence to establish that it was received at
the Government installation designated for receipt of offers and was
under the Government\'s control prior to the time set for receipt of
offers; or

3\. It is the only proposal received.

\(b\) However, a late modification of an otherwise successful proposal
that makes its terms more favorable to the Government, will be
considered at any time it is received and may be accepted.

\(c\) Acceptable evidence to establish the time of receipt at the
Government installation includes the time/date stamp of that
installation on the proposal wrapper, other documentary evidence of
receipt maintained by the installation, or oral testimony or statements
of Government personnel.

\(d\) If an emergency or unanticipated event interrupts normal
Government processes so that proposals cannot be received at the office
designated for receipt of proposals by the exact time specified in the
solicitation, and urgent Government requirements preclude amendment of
the solicitation, the time specified for receipt of proposals will be
deemed to be extended to the same time of day specified in the
solicitation on the first work day on which normal Government processes
resume.

\(e\) Proposals may be withdrawn by written notice received at any time
before award. Oral proposals in response to oral solicitations may be
withdrawn orally. If the solicitation authorizes facsimile proposals,
proposals may be withdrawn via facsimile received at any time before
award, subject to the conditions specified in the provision at 52.215-5,
Facsimile Proposals. Proposals may be withdrawn in person by an offeror
or an authorized representative, if the identity of the person
requesting withdrawal is established and the person signs a receipt for
the proposal before award.

\(5\) Unless otherwise specified in the solicitation, the offeror may
propose to provide any item or combination of items.

\(6\) Offerors shall submit proposals in response to this solicitation
in English, unless otherwise permitted by the solicitation, and in U.S.
dollars, unless the provision at FAR 52.225-17, Evaluation of Foreign
Currency Offers, is included in the solicitation.

\(7\) Offerors may submit modifications to their proposals at any time
before the solicitation closing date and time, and may submit
modifications in response to an amendment, or to correct a mistake at
any time before award.

\(8\) Offerors may submit revised proposals only if requested or allowed
by the Contracting Officer.

\(9\) Proposals may be withdrawn at any time before award. Withdrawals
are effective upon receipt of notice by the Contracting Officer.

\(10\) *Offer expiration date*. Proposals in response to this
solicitation will be valid for the number of days specified on the
solicitation cover sheet (unless a different period is proposed by the
offeror).

\(11\) *Restriction on disclosure and use of data.* (1) The proposal
submitted in response to this request

> may contain data (trade secrets; business data, e.g., commercial
> information, financial Information, and cost and pricing data; and
> technical data) which the offeror, including its prospective
> subcontractor(s), does not want used or disclosed for any purpose
> other than for evaluation of the proposal. The use and disclosure of
> any data may be so restricted; provided, that the Government
> determines that the data is not required to be disclosed under the
> Freedom of Information Act, 5 U.S.C. 552, as amended, and the offeror
> marks the cover sheet of the proposal with the following legend,
> specifying the particular portions of the proposal which are to be
> restricted in accordance with the conditions of the legend. The
> Government\'s determination to withhold or disclose a record will be
> based upon the particular circumstances involving the record in
> question and whether the record may be exempted from disclosure under
> the Freedom of Information Act. The legend reads:

Unless disclosure is required by the Freedom of Information Act, 5
U.S.C. 552, as amended, (the Act) as determined by Freedom of
Information (FOI) officials of the Department of Health and Human
Services, data contained in the portions of this proposal which have
been specifically identified by page number, paragraph, etc. by the
offeror as containing restricted information shall not be used or
disclosed except for evaluation purposes.

The offeror acknowledges that the Department may not be able to withhold
a record (data, document, etc.) nor deny access to a record requested
pursuant to the Act and that the Department\'s FOI officials must make
that determination. The offeror hereby agrees that the Government is not
liable for disclosure if the Department has determined that disclosure
is required by the Act.

If a contract is awarded to the offeror as a result of, or in connection
with, the submission of this proposal, the Government shall have right
to use or disclose the data to the extent provided in the contract.
Proposals not resulting in a contract remain subject to the Act.

The offeror also agrees that the Government is not liable for disclosure
or use of unmarked data and may use or disclose the data for any
purpose, including the release of the information pursuant to requests
under the Act. The data subject to this restriction are contained in
pages (insert page numbers, paragraph designations, etc. or other
identification).

In addition, the offeror should mark each page of data it wishes to
restrict with the following statement:

"Use or disclosure of data contained on this page is subject to the
restriction on the cover sheet of this proposal or quotation."

Offerors are cautioned that proposals submitted with restrictive legends
or statements differing in substance from the above legend may not be
considered for award. The Government reserves the right to reject any
proposal submitted with a nonconforming legend.

\(12\) *Contract award*.

\(a\) The Government intends to award a contract or contracts resulting
from this solicitation

> to the responsible offeror(s) whose proposal(s) represents the best
> value after evaluation in accordance with the factors and subfactors
> in the solicitation.

\(b\) The Government may reject any or all proposals if such action is
in the Government\'s interest.

> \(c\) The Government may waive informalities and minor irregularities
> in proposals received.
>
> \(d\) The Government intends to evaluate proposals and award a
> contract without discussions with offerors (except clarifications as
> described in FAR 15.306(a)). Therefore, the offeror\'s initial
> proposal should contain the offeror\'s best terms from a cost or price
> and technical standpoint. The Government reserves the right to conduct
> discussions if the Contracting Officer later determines them to be
> necessary. If the Contracting Officer determines that the number of
> proposals that would otherwise be in the competitive range exceeds the
> number at which an efficient competition can be conducted, the
> Contracting Officer may limit the number of proposals in the
> competitive range to the greatest number that will permit an efficient
> competition among the most highly rated proposals.

\(e\) The Government reserves the right to make an award on any item for
a quantity less than the quantity offered, at the unit cost or prices
offered, unless the offeror specifies otherwise in the proposal.

\(f\) The Government reserves the right to make multiple awards if,
after considering the additional administrative costs, it is in the
Government\'s best interest to do so.

\(g\) Exchanges with offerors after receipt of a proposal do not
constitute a rejection or counteroffer by the Government.

\(h\) The Government may determine that a proposal is unacceptable if
the prices proposed are materially unbalanced between line items or
subline items. Unbalanced pricing exists when, despite an acceptable
total evaluated price, the price of one or more contract line items is
significantly overstated or understated as indicated by the application
of cost or price analysis techniques. A proposal may be rejected if the
Contracting Officer determines that the lack of balance poses an
unacceptable risk to the Government.

\(i\) If a cost realism analysis is performed, cost realism may be
considered by the source selection authority in evaluating performance
or schedule risk.

\(j\) A written award or acceptance of proposal mailed or otherwise
furnished to the successful offeror within the time specified in the
proposal shall result in a binding contract without further action by
either party.

\(k\) If a post-award debriefing is given to requesting offerors, the
Government shall disclose the following information, if applicable:

1\. The agency\'s evaluation of the significant weak or deficient
factors in the debriefed offeror\'s offer.

2\. The overall evaluated cost or price and technical rating of the
successful and debriefed offeror and past performance information on the
debriefed offeror.

3\. The overall ranking of all offerors, when any ranking was developed
by the agency during source selection;

4\. A summary of the rationale for award.

5\. For acquisitions of commercial items, the make and model of the item
to be delivered by the successful offeror.

6\. Reasonable responses to relevant questions posed by the debriefed
offeror as to whether source-selection procedures set forth in the
solicitation, applicable regulations, and other applicable authorities
were followed by the agency.

(End of Provision)

**b. NAICS CODE AND SIZE STANDARD**

> Note: The following information is to be used by the offeror in
> preparing its Representations and Certifications (See Section K of
> this RFP), specifically in completing the provision entitled, SMALL
> BUSINESS PROGRAM REPRESENTATION, FAR Clause 52.219-1.
>
> \(1\) The North American Industry Classification System (NAICS) code
> for this acquisition is 541710 .

\(2\) The small business size standard is 500 employees.

> **THIS REQUIREMENT IS NOT SET-ASIDE FOR SMALL BUSINESS. However, the
> Federal Acquisition Regulation (FAR) requires in EVERY solicitation,
> (except for foreign acquisitions) the inclusion of the North American
> Industry Classification (NAICS) Code and corresponding size standard
> which best describes the nature of the requirement in the
> solicitation.**

c.  **TYPE OF CONTRACT AND NUMBER OF AWARD(S)**

> It is anticipated that One Award will be made from this solicitation
> and that the award will be made on or about February 1, 2007. .
>
> It is anticipated that the award from this solicitation will be a
> multiple-year cost reimbursement type completion contract and a term
> of seven years. Incremental funding will be used \[see Section L.2.c.
> Business Proposal Instructions\]. Multiple options for additional
> services are anticipated. These options if exercised will not exceed
> the seven year period of performance of the basic effort.

d.  **ESTIMATE OF EFFORT**

> It is expected that a completion type contract will be awarded as a
> result of this RFP. To assist you in the preparation of your proposal,
> the Government considers the basic effort to be approximately 62.8
> full time equivalents (FTE's) per year. The level of effort for the
> options, if exercised, will vary but the government estimates a total
> of 6.5 full time equivalents. This information is furnished for the
> offeror\'s information only and is not to be considered restrictive
> for proposal purposes.

e.  **COMMITMENT OF PUBLIC FUNDS**

> The Contracting Officer is the only individual who can legally commit
> the Government to the expenditure of public funds in connection with
> the proposed procurement. Any other commitment, either explicit or
> implied, is invalid.

f.  **COMMUNICATIONS PRIOR TO CONTRACT AWARD**

> Offerors shall direct all communications to the attention of the
> Contract Specialist or Contracting Officer cited on the face page of
> this RFP. Communications with other officials may compromise the
> competitiveness of this acquisition and result in cancellation of the
> requirement.

g.  **RELEASE OF INFORMATION**

> Contract selection and award information will be disclosed to offerors
> in accordance with regulations applicable to negotiated acquisition.
> Prompt written notice will be given to unsuccessful offerors as they
> are eliminated from the competition, and to all offerors following
> award.

h.  **COMPARATIVE IMPORTANCE OF PROPOSALS**

> You are advised that paramount consideration shall be given to the
> evaluation of technical proposals. All evaluation factors other than
> cost or price, when combined, are significantly more important than
> cost or price. The relative importance of the evaluation factors are
> specified in SECTION M of this solicitation. However, the Government
> reserves the right to make an award to the best advantage of the
> Government, cost and other factors considered.

i.  **PREPARATION COSTS**

> This RFP does not commit the Government to pay for the preparation and
> submission of a proposal.

j.  **SERVICE OF PROTEST** (AUGUST 1996) - FAR 52.233-2

\(a\) Protests, as defined in section 33.101 of the Federal Acquisition
Regulation, that are filed directly with an agency, and copies of any
protests that are filed with the General Accounting Office (GAO), shall
be served on the Contracting Officer (addressed as follows) by obtaining
written and dated acknowledgment of receipt from:

> Contracting Officer
>
> Office of Acquisitions
>
> NIH, NIAID
>
> Room 3214
>
> 6700-B Rockledge Drive, MSC 7612
>
> BETHESDA MD 20892-7612
>
> \(b\) The copy of any protest shall be received in the office
> designated above within one day of filing a protest with the GAO.

(End of Provision)

k.  **LATE PROPOSALS AND REVISIONS**, HHSAR 352.215-70

Notwithstanding the procedures contained in FAR 52.215-1(c)(3) of the
provision of this solicitation entitled Instructions to
Offerors-Competitive Acquisition, a proposal received after the date
specified for receipt may be considered if it offers significant cost or
technical advantages to the Government; and it was received before
proposals were distributed for evaluation, or within five calendar days
after the exact time specified for receipt, whichever is earlier.

(End of provision)

2\. INSTRUCTIONS TO OFFERORS[]{#LINSTRUCTIONSTOOFFERORS .anchor}

a\. GENERAL INSTRUCTIONS

**INTRODUCTION**

> The following instructions will establish the acceptable minimum
> requirements for the format and contents of proposals. Special
> attention is directed to the requirements for technical and business
> proposals to be submitted in accordance with these instructions.

(1) **(1)** **Contract Type and General Clauses**

> It is contemplated that a cost-reimbursement, completion type contract
> will be awarded. (See General Information) Any resultant contract
> shall include the clauses applicable to the selected offeror\'s
> organization and type of contract awarded as required by Public Law,
> Executive Order, or acquisition regulations in effect at the time of
> execution of the proposed contract.

(2) **Authorized Official and Submission of Proposal**

> The proposal must be signed by an official authorized to bind your
> organization and must stipulate that it is predicated upon all the
> terms and conditions of this RFP. Your proposal shall be submitted in
> the number of copies, to the addresses, and marked as indicated in the
> Attachment entitled, PACKAGING AND DELIVERY OF PROPOSAL, Part III,
> Section J hereof. Proposals will be typewritten, paginated, reproduced
> on letter size paper and will be legible in all required copies. To
> expedite the proposal evaluation, all documents required for
> responding to the RFP should be placed in the following order:

I. COVER PAGE

> Include RFP title, number, name of organization, DUNS No.,
> identification of the proposal part, and indicate whether the proposal
> is an original or a copy.

II\. TECHNICAL PROPOSAL

> It is recommended that the technical proposal consist of a cover page,
> a table of contents, and the information requested in the Technical
> Proposal Instructions and as specified in SECTION J, List of
> Attachments.

III\. BUSINESS PROPOSAL

> It is recommended that the business proposal consist of a cover page,
> a table of contents, and the information requested in the Business
> Proposal Instructions and as specified in SECTION J, List of
> Attachments.

(3) **Proposal Summary and Data Record (NIH-2043)**

> The Offeror must complete the Form NIH-2043, attached, with particular
> attention to the length of time the proposal is firm and the
> designation of those personnel authorized to conduct negotiations.
> (See Section J, Attachment entitled, PROPOSAL SUMMARY AND DATA
> RECORD.)

(4) **Separation of Technical and Business Proposals**

> The proposal must be prepared in two parts: a \"Technical Proposal\"
> and a \"Business Proposal.\" Each of the parts shall be separate and
> complete in itself so that evaluation of one may be accomplished
> independently of, and concurrently with, evaluation of the other. The
> technical proposal must include direct cost and resources information,
> such as labor-hours and categories and applicable rates, materials,
> subcontracts, travel, etc., and associated costs so that the
> offeror\'s understanding of the project may be evaluated (See
> Attachment entitled, TECHNICAL PROPOSAL COST INFORMATION/SUMMARY OF
> LABOR AND DIRECT COSTS). However, the technical proposal should
> **not** include pricing data relating to individual salary
> information, indirect cost rates or amounts, fee amounts (if any), and
> total costs. The technical proposal should disclose your technical
> approach in as much detail as possible, including, but not limited to,
> the requirements of the technical proposal instructions.

(5) **Alternate Proposals**

> You may, at your discretion, submit alternate proposals, or proposals
> which deviate from the requirements; provided, that you also submit a
> proposal for performance of the work as specified in the statement of
> work. Such proposals may be considered if overall performance would be
> improved or not compromised and if they are in the best interests of
> the Government. Alternative proposals, or deviations from any
> requirements of this RFP, shall be clearly identified.

(6) **Evaluation of Proposals**

> The Government will evaluate technical proposals in accordance with
> the criteria set forth in Part IV, Section M of this RFP.

(7) **Potential Award Without Discussions**

The Government reserves the right to award a contract without
discussions if the Contracting Officer determines that the initial
prices are fair and reasonable and that discussions are not necessary.

(8) **Use of the Metric System of Measurement**

It is the policy of the Department of Health and Human Services to
support the Federal transition to the metric system and to use the
metric system of measurement in all procurement, grants, and other
business related activities unless such use is impracticable or is
likely to cause significant inefficiencies.

The offeror is encouraged to prepare their proposal using either \"Hard
Metric,\" \"Soft Metric,\" or \"Dual Systems\" of measurement. The
following definitions are provided for your information:

**Hard Metric** - The replacement of a standard inch-pound size with an
accepted metric size for a particular purpose. An example of size
substitution might be: selling or packaging liquids by the liter instead
of by the pint or quart (as for soft drinks), or instead of by the
gallon (as for gasoline).

**Soft Metric** - The result of a mathematical conversion of inch-pound
measurements to metric equivalents for a particular purpose. The
physical characteristics are not changed.

**Dual Systems** - The use of both inch-pound and metric systems. For
example, an item is designed, produced, and described in inch-pound
values with soft metric values also shown for information or comparison
purposes.

(9) **Standards for Privacy of Individually Identifiable Health
    Information**

The Department of Health and Human Services (DHHS) issued final
modifications to the "Standards for Privacy of Individually Identifiable
Health Information," the "Privacy Rule," on August 14, 2002. The Privacy
Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of
individually identifiable health information and is administered and
enforced by the DHHS Office for Civil Rights (OCR). Those who must
comply with the Privacy Rule (classified under the Rule as "covered
entities" must do so by April 14, 2003 (with the exception of small
health plans which have an extra year to comply.

Decisions about the applicability and implementation of the Privacy Rule
reside with the contractor and his/her institution. The OCR Web site
([[http://www.hhs.gov/ocr/]{.underline}](http://www.hhs.gov/ocr/))
provides information of the Privacy Rule, including a complete
Regulation Text and a set of decision tools on "Am I a covered entity?"
Information on the impact of the HIPAA Privacy Rule on NIH processes
involving the review, award, and administration of grants, cooperative
agreements and contracts can be found at:
[[http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html]{.underline}](http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html).

(10) **Care of Live Vertebrate Animals**

> a\. The following notice is applicable when contract performance is
> expected to involve care of live vertebrate animals:

**Notice to Offerors of Requirement for Compliance with the Public
Health Service Policy on Humane Care and Use of Laboratory Animals
(Revised 1986, Reprinted 2000)**

> The Public Health Service (PHS) Policy on Human Care and Use of
> Laboratory Animals establishes a number of requirements for research
> activities involving animals. Before a PHS award may be made to an
> applicant organization, the organization shall file, with the Office
> of Extramural Research (OER), Office of Laboratory Animal Welfare
> (OLAW), National Institutes of Health (NIH), PHS, a written Animal
> Welfare Assurance which commits the organization to comply with the
> provisions of the PHS Policy on Humane Care and Use of Laboratory
> Animals by Awardee Institutions, the Animal Welfare Act, and the Guide
> for the Care and Use of Laboratory Animals prepared by the Institute
> of Laboratory Animal Resources. In accordance with the PHS Policy on
> Humane Care and Use of Laboratory Animals by Awardee Institutions,
> applicant organizations must establish a committee, qualified through
> the experience and expertise of its members, to oversee the
> institution\'s animal program, facilities and procedures. No PHS award
> involving the use of animals shall be made unless the Animal Welfare
> Assurance has been approved by OER, OLAW. Prior to award, the
> Contracting Officer will notify Contractor(s) selected for projects
> that involve live vertebrate animals that an Animal Welfare Assurance
> is required. The Contracting Officer will request that OER, OLAW
> negotiate an acceptable Animal Welfare Assurance with those
> Contractor(s). For further information, OER, OLAW, may be contacted at
> Rockledge Center I - Suite 1050, 6705 Rockledge Drive, Bethesda, MD
> 20817, (301) 496-7163, ext 234. FAX copies of the PHS Policy are
> available at (301) 402-2803. This policy is also available on the
> internet at
> [[http://www.grants.nih.gov/grants/olaw/olaw.htm]{.underline}](http://www.grants.nih.gov/grants/olaw/olaw.htm).

b\. The following information must be included in the offerors technical
proposal:

\- identification of the species and approximate number of animals to be
used;

\- rationale for involving animals, and for the appropriateness of the
species and numbers used;

\- a complete description of the proposed use of the animals;

\- a description of procedures designed to assure that discomfort and
injury to animals will be limited to that which is unavoidable in the
conduct of scientifically valuable research, and that analgesic,
anesthetic, and tranquilizing drugs will be used where indicated and
appropriate to minimize discomfort and pain to animals; and

\- a description of any euthanasia method to be used.

c\. If an Animal Assurance is already in place, the offeror\'s proposal
shall include:

-The Animal Welfare Assurance number.

-The date last certified by OLAW. (i.e. assurance letter from OLAW)

-Evidence of recent AAALAC Accreditation.

(11) **Possession, Use and Transfer of Select Biological Agents or
     Toxins**

**Notice to Offerors of Requirements of:** 42 CFR Part 73, Possession ,
Use, and Transfer of Select Agents and Toxins (relating to public health
and safety):

([[http://www.cdc.gov/od/sap/42_cfr_73_final_rule.pdf]{.underline}](http://www.cdc.gov/od/sap/42_cfr_73_final_rule.pdf));

7 CFR Part 331, Possession, Use, and Transfer of Select Agents and
Toxins (relating to plant health or plant products)
([[http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf]{.underline}](http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf));
and,

9 CFR Part 121, Possession, Use, and Transfer of Select Agents and
Toxins (relating to human and animal health, animal health or animal
products)

([[http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf]{.underline}](http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf)) -
March 18, 2005.

These regulations implement the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, and the Agricultural Bioterrorism
Protection Act of 2002. They are designed to improve the ability of the
United States Government to prevent, prepare for, and respond to
bioterrorism and other public health emergencies. These regulations
establish requirements regarding registration, security risk
assessments, safety plans, security plans, emergency response plans,
training, transfers, record keeping, inspections, and notifications.

Listings of HHS select agents and toxins, and overlap select agents or
toxins as well as information about the registration process for
domestic institutions, are available on the Select Agent Program Web
site at
[[http://www.cdc.gov/od/sap/]{.underline}](http://www.cdc.gov/od/sap/)
and
[[http://www.cdc.gov/od/sap/docs/salist.pdf]{.underline}](http://www.cdc.gov/od/sap/docs/salist.pdf).
Listings of USDA select agents and toxins as well as information about
the registration process for domestic institutions are available on the
APHIS/USDA website at
[[http://www.aphis.usda.gov/programs/ag_selectagent/index.html]{.underline}](http://www.aphis.usda.gov/programs/ag_selectagent/index.html)
and
[[http://www.aphis.usda.gov/programs/ag_selectagent/ag_bioterr_forms.html]{.underline}](http://www.aphis.usda.gov/programs/ag_selectagent/ag_bioterr_forms.html).
For foreign institutions, see the NIAID Select Agent Award information
([[http://www.niaid.nih.gov/ncn/clinical/default_biodefense.htm]{.underline}](http://www.niaid.nih.gov/ncn/clinical/default_biodefense.htm)).

If the proposed contract will not involve Select Agents, the offeror
must include a statement in its technical proposal that the work does
not now nor will it in the future (i.e. throughout the life of the
award) involve Select Agents.

**Domestic Institutions**

For prime or subcontract awards to domestic institutions that possess,
use, and/or transfer Select Agents under this contract, the domestic
institution must:

1.  include details about the select agent in their technical proposal,
    including the quantity proposed to be used during contract
    performance.

2.  comply with 42 CFR part 73, 7 CFR part 331 and/or 9 CFR part 121 at:

> [[http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf]{.underline}](http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf),
> as required, before using NIH funds for research involving Select
> Agents. No NIH funds can be used for research involving Select Agents
> if the final registration certificate is denied.

**Foreign Institutions**

For prime or subcontract awards to foreign institutions that possess,
use, and/or transfer Select Agents under this contract, the foreign
institution must:

3.  include details about the select agent in their technical proposal,
    including the quantity proposed to be used during contract
    performance.

4.  when requested during negotiations, provide information satisfactory
    to the NIAID/NIH that safety, security, and training standards
    equivalent to those described in 42 CFR part 73, 7 CFR part 331,
    and/or 9 CFR part 121 at:
    [[http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf]{.underline}](http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf)
    for U.S. institutions are in place and will be administered on
    behalf of all Select Agent work under the resulting contract. The
    process for making this determination includes inspection of the
    foreign laboratory facility by an NIAID representative. During this
    inspection, the foreign institution must provide the following
    information: concise summaries of safety, security, and training
    plans; names of all individuals at the foreign institution who will
    have access to the Select Agents and procedures for ensuring that
    only approved and appropriate individuals, in accordance with
    institution procedures, will have access to the Select Agents under
    the contract; and copies of or links to any applicable laws,
    regulations, policies, and procedures applicable to that institution
    for the safe and secure possession, use, and/or transfer of select
    agents.

An NIAID-chaired committee of U.S. federal employees (including
representatives of NIH grants/contracts and scientific program
management, CDC , Department of Justice and other federal intelligence
agencies, and Department of State) will ultimately assess the results of
the facility inspection, the regulations, policies, and procedures of
the foreign institution for equivalence to the U.S. requirements
described in 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 at:
[[http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf]{.underline}](http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf).

The committee will provide recommendations to the DEA Director, NIAID.
The DEA Director will make the approval decision and notify the
Contracting Officer. The Contracting Officer will inform the prime
contractor of the approval status of the foreign institution. No NIH
funds can be used for research involving Select Agents at a foreign
institution until NIAID grants this approval.

**(12) Obtaining and Disseminating Biomedical Research Resources**

> As a public sponsor of biomedical research, the National Institutes of
> Health (NIH) has a dual interest in accelerating scientific discovery
> and facilitating product development. Intellectual property
> restrictions can stifle the broad dissemination of new discoveries and
> limit future avenues of research and product development. At the same
> time, reasonable restrictions on the dissemination of research tools
> are sometimes necessary to protect legitimate proprietary interests
> and to preserve incentives for commercial development. To assist NIH
> contractors achieve an appropriate balance, the NIH has provided
> guidance in the form of a two-part document, consisting of Principles
> setting forth the fundamental concepts and Guidelines that provide
> specific information to patent and license professionals and sponsored
> research administrators for implementation.
>
> The purpose of these Principles and Guidelines is to assist NIH
> funding recipients in determining: 1) Reasonable terms and conditions
> for making NIH-funded research resources available to scientists in
> other institutions in the public and private sectors (disseminating
> research tools); and 2) Restrictions to accept as a condition of
> receiving access to research tools for use in NIH-funded research
> (acquiring research tools). The intent is to help recipients ensure
> that the conditions they impose and accept on the transfer of research
> tools will facilitate further biomedical research, consistent with the
> requirements of the Bayh-Dole Act and NIH funding policy.
>
> This policy, entitled, \"Sharing Biomedical Research Resources:
> Principles and Guidelines for Recipients of NIH Research Grants and
> Contracts,\" (Federal Register Notice, December 23, 1999 \[64 FR
> 72090\] will be included in any contract awarded from this
> solicitation. It can be found at the following website:
> [http://ott.od.nih.gov/NewPages/64FR72090.pdf]{.underline}.

\(a\) **Sharing Research Data**

*\[Note: The NIH Guide announcement referenced below states that this
policy is applicable to \"all investigator-initiated applications with
direct costs greater than \$500,000 in any single year.\" This is an
overall grant policy which requires that an applicant must seek
agreement by NIH to accept assignment of their application in advance of
the submission date. As such, this policy has no correlation to the
contract process, therefore, the threshold is not applicable to
contracts. Thus, this article applies to **[any]{.underline}** contract
that may generate research data.\]*

The NIH endorses the sharing of final research data to expedite the
translation of research results into knowledge, products, and procedures
to improve human health. This contract is expected to generate research
data. Therefore, the offeror must submit a plan for data sharing or
state why data sharing is not possible. If data sharing is limited, the
offeror should explain such limitations in its data sharing plan. NIH\'s
data sharing policy may be found at the following Web site:

[[http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html)

If the resultant contract is part of a collaborative program involving
multiple sites, the data sharing will be governed by a dissemination
plan to be developed jointly following award. Offerors must include in
their proposals a statement of willingness to work collaboratively after
award with the other funded sites to prepare a joint dissemination plan.
Coordinating Center proposals should describe methods to coordinate the
dissemination planning and implementation. The Coordinating Center must
include a budget and justification for any additional costs of this
collaborative effort.

\(b\) **Sharing of Model Organisms for Biomedical Research**

The , also referred to as Principles and Guidelines for Recipients of
NIH Research Grants and Contracts on Obtaining and Disseminating
Biomedical Research Resources: Final Notice, December 1999, supports the
concept of timely sharing and distribution of research resources. In
accordance with NIH Guide Notice , dated May 7, 2004, and the September
10, 2004 extension of this policy , the NIH provides further sharing
guidance with particular attention on model organisms for biomedical
research. Such organisms include, but are not limited to: mammalian
models such as the mouse and rat, and non-mammalian models, such as
budding yeast, social amoebae, round worm, fruit fly, zebra fish, and
frog. Research resources to be shared include genetically modified or
mutant organisms, sperm, embryos, protocols for genetic and phenotypic
screens, mutagenesis protocols, and genetic and phenotypic data for all
mutant strains.

Offerors must include in their proposal a description of a specific plan
for sharing and distributing unique model organism research resources
generated using NIH funding so that other researchers can benefit from
these resources, OR provide appropriate reasons why such sharing is
restricted or not possible. A reasonable time frame for periodic
disposition of material and associated data must be specified in the
proposal. In addition, the plan must address if, or how, offerors will
exercise their intellectual property rights while making model organisms
and research resources available to the broader scientific community. At
a minimum, the plan should address the following:

\- Will material transfers be made with no more restrictive terms than
in a Simple Letter Agreement (SLA) ( for the transfer of materials or
the Uniform Biological Material Transfer Agreement (UBMTA) ()

> \- How will inappropriate "reach-through" requirements (as discussed
> in the NIH Research Tools Policy) on materials transferred be
> discussed?
>
> \- How will technologies remain widely available and accessible to the
> research community, for example, if any intellectual property rights
> arise for which a patent application may be filed?

Offerors may request funds in their cost proposal to defray reasonable
costs associated with sharing materials or data or transfer of model
organisms and associated data to appropriate repositories.

**(13)** **Privacy Act - Treatment of Proposal Information**

> The Privacy Act of 1974 (P.L. 93-579) requires that a Federal agency
> advise each individual whom it asks to supply information, the
> authority which authorizes the solicitation, whether disclosure is
> voluntary or mandatory, the principal purpose or purposes for which
> the information is intended to be used, the uses outside the agency
> which may be made of the information, and the effects on the
> individual, if any, of not providing all or any part of the requested
> information.
>
> The NIH is requesting the information called for in this RFP pursuant
> to the authority provided by Sec. 301(a)(7) of the Public Health
> Service Act, as amended, and P.L. 92-218, as amended.
>
> Providing the information requested is entirely voluntary. The
> collection of this information is for the purpose of conducting an
> accurate, fair, and adequate review prior to a discussion as to
> whether to award a contract.
>
> Failure to provide any or all of the requested information may result
> in a less than adequate review.
>
> In addition, the Privacy Act of 1974 (P.L. 93-579, Section 7) requires
> that the following information be provided when individuals are
> requested to disclose their social security number.
>
> Provision of the social security number is voluntary. Social security
> numbers are requested for the purpose of accurate and efficient
> identification, referral, review and management of NIH contracting
> programs. Authority for requesting this information is provided by
> Section 301 and Title IV of the PHS Act, as amended.
>
> The information provided by you may be routinely disclosed for the
> following purposes:

\- to the cognizant audit agency and the General Accounting Office for
auditing.

\- to the Department of Justice as required for litigation.

\- to respond to congressional inquiries.

\- to qualified experts, not within the definition of Department
employees, for opinions as a part of the review process.

**(14)** **Selection of Offerors**

a.  The acceptability of the scientific and technical portion of each
    research contract proposal will be evaluated by a technical review
    committee. The committee will evaluate each proposal in strict
    conformity with the evaluation criteria of the RFP, utilizing point
    scores and written critiques. The committee may suggest that the
    Contracting Officer request clarifying information from an offeror.

b.  The business portion of each contract proposal will be subjected to
    a cost and price analysis,

> management analysis, etc.

c.  If award will be made without conducting discussions, offerors may
    be given the opportunity to clarify certain aspects of their
    proposal (e.g., the relevance of an offeror\'s past performance
    information and adverse past performance information to which the
    offeror has not previously had an opportunity to respond) or to
    resolve minor or clerical errors.

d.  If the Government intends to conduct discussions prior to awarding a
    contract-

\(1\) Communications will be held with offerors whose past performance
information is the determining factor preventing them from being placed
within the competitive range. Such communications shall address adverse
past performance information to which an offeror has not had a prior
opportunity to respond. Also, communications may be held with any other
offerors whose exclusion from, or inclusion in, the competitive range is
uncertain.

Such communications shall not be used to cure proposal deficiencies or
omissions that alter the technical or cost elements of the proposal,
and/or otherwise revise the proposal, but may be considered in rating
proposals for the purpose of establishing the competitive range.

\(2\) The Contracting Officer will, in concert with program staff,
decide which proposals are in the competitive range. The competitive
range will be comprised of all of the most highly rated proposals. Oral
or written discussions will be conducted with all offerors in the
competitive range.

While it is NIAID\'s policy to conduct discussions with all offerors in
the competitive range, NIAID reserves the right, in special
circumstances, to limit the number of proposals included in the
competitive range to the greatest number that will permit an efficient
competition. All aspects of the proposals are subject to discussions,
including cost, technical approach, past performance, and contractual
terms and conditions. At the conclusion of discussions, each offeror
still in the competitive range shall be given an opportunity to submit a
written Final Proposal Revision (FPR) with the reservation of the right
to conduct finalization of details with the selected source in
accordance with HHSAR 315.370.

e\) The process described in FAR 15.101-1 will be employed, which
permits the Government to make tradeoffs among cost or price and
non-cost factors and to consider award to other than the lowest price
offeror or other than the highest technically rated offeror. This
process will take into consideration the results of the technical
evaluation, the past performance evaluation (if applicable) and the cost
analysis.

f\) The NIAID reserves the right to make a single award, multiple
awards, or no award at all to the RFP. In addition, the RFP may be
amended or canceled as necessary to meet NCI requirements. Synopses of
awards exceeding \$25,000 will be published in FedBizOpps.

**(15)** **Small Business Subcontracting Plan**

> If the proposed contract exceeds a total estimated cost of \$500,000
> for the entire period of performance, the apparent successful offeror
> shall be required to submit an acceptable subcontracting plan in
> accordance with the terms of the clause entitled \"Small Business
> Subcontracting Plan,\" FAR Clause No. 52.219-9, incorporated herein by
> reference in the Solicitation, Attachment to this RFP is an example of
> such a plan.

a\) THIS PROVISION DOES NOT APPLY TO SMALL BUSINESS CONCERNS.

b\) The term \"subcontract\" means any agreement (other than one
involving an employer-employee relationship) entered into by a Federal
Government prime contractor or subcontractor calling for supplies or
services required for the performance of the original contract or
subcontract. This includes, but is not limited to, agreements/purchase
orders for supplies and services such as equipment purchase, copying
services, and travel services.

c\) The offeror understands that:

> \(1\) No contract will be awarded unless and until an acceptable plan
> is negotiated with the Contracting Officer which plan will be
> incorporated into the contract, as a material part thereof.

\(2\) An acceptable plan must, in the determination of the Contracting
Officer, provide the maximum practicable opportunity for Small
Businesses, Small Disadvantaged Businesses, Women-Owned Small
businesses, HubZone Small Businesses, Veteran-Owned Small Businesses,
and Service Disabled Veteran-Owned Small Businesses to participate in
the performance of the contract.

> \(3\) If a subcontracting plan acceptable to the Contracting Officer
> is not negotiated within the time limits prescribed by the contracting
> activity and such failure arises out of causes within the control and
> with the fault or negligence of the offeror, the offeror shall be
> ineligible for an award. The Contracting Officer shall notify the
> Contractor in writing of the reasons for determining a subcontracting
> plan unacceptable early enough in the negotiation process to allow the
> Contractor to modify the plan within the time limits prescribed.
>
> \(4\) Prior compliance of the offeror with other such subcontracting
> plans under previous contracts will be considered by the Contracting
> Officer in determining the responsibility of the offeror for award of
> the contract.
>
> \(5\) It is the offeror\'s responsibility to develop a satisfactory
> subcontracting plan with respect to Small Business Concerns, Small
> Disadvantaged Business Concerns, Women-Owned Small Business Concerns,
> HubZone Small Business Concerns, Veteran-Owned Small Business
> Concerns, and Service Disabled Veteran-Owned Small Business Concerns
> that each such aspect of the offeror\'s plan will be judged
> independent of the other.
>
> \(6\) The offeror will submit, as required by the Contracting Officer,
> subcontracting reports in accordance with the instructions thereon,
> and as further directed by the Contracting Officer. Subcontractors
> will also submit these reports to the Government\'s Contracting
> Officer or as otherwise directed, with a copy to the prime
> Contractor\'s designated small and disadvantaged business liaison.

d\) Each plan must contain the following:

\(1\) Goals, expressed in terms of percentages of total planned
subcontracting dollars, for the use of Small, Small Disadvantaged,
Women-Owned, HUBZone, Veteran-Owned, and Service Disabled Veteran-Owned
Small Business Concerns as subcontractors.

\(2\) A statement of total dollars planned to be subcontracted. A
statement of total dollars to be subcontracted to each of the following
type of small business concerns: Small, Small Disadvantaged,
Women-Owned, HUBZone, Veteran-Owned, and Service Disabled Veteran-Owned
Small Businesses.

\(3\) A description of the principal types of supplies and services to
be subcontracted with an identification of which supplies and services
are expected to be subcontracted to Small, Small Disadvantaged,
Women-Owned, HUBZone, Veteran-Owned, and/or Service Disabled
Veteran-Owned Small Business Concerns.

\(4\) A description of the method used to develop the subcontracting
goals.

\(5\) A description of the method used to identify potential sources for
solicitation purposes.

\(6\) A statement as to whether or not indirect costs were included in
establishing subcontracting goals. If they were, a description of the
method used to determine the proportionate share of indirect costs to be
incurred with Small, Small Disadvantaged, Women-Owned, HUBZone,
Veteran-Owned, and Service Disabled Veteran-Owned Small Businesses.

\(7\) The name of the individual employed by the offeror who will
administer the offeror\'s subcontracting program and a description of
his/her duties.

\(8\) A description of the efforts the offeror will make to assure that
Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and
Service Disabled Veteran-Owned Small Businesses have an equitable chance
to compete for subcontracts.

\(9\) Assurances that the offeror will include in all subcontracts the
contract clause \"Utilization of Small Business Concerns.\" Assure that
all subcontractors, other than small businesses, in excess of \$500,000
adopt a plan similar to the plan agreed upon by the offeror.

\(10\) Assurances that the offeror (and any required subcontractors)
will cooperate in studies or surveys as required and submit required
reports (SF 294 and SF 295) to the Government.

\(11\) List the types of records the offeror will maintain to
demonstrate procedures that have been adopted to comply with the
requirement and goals in the plan, including establishing source lists.
Also, the offeror shall describe its efforts to locate Small, Small
Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and Service Disabled
Veteran-Owned Small Businesses and award subcontracts to them.

For additional information about each of the above elements required to
be contained the subcontracting plan, see FAR Clause 52.219-9, Small
Business Subcontracting Plan, and the Sample Subcontracting Plan which
is provided as an attachment to this RFP in SECTION J.

HHS expects each procuring activity to establish minimum subcontracting
goals for all procurements. The anticipated minimum goals for this RFP
are as follows:

23% for Small Business; 5% for Small Disadvantaged Business; 5% for
Women-Owned Small Business; 5% for HUBZone Small Business; and 3% for
Veteran-Owned Small Business and Service-Disabled Veteran-Owned Small
Business.

**(16)** **HUBZone Small Business Concerns**

Small Business offerors located in underutilized business zones, called
\"HUBZones,\" will be evaluated in accordance with FAR Clause 52.219-4,
NOTICE OF PRICE EVALUATION PREFERENCE FOR HUBZONE SMALL BUSINESS
CONCERNS, which is incorporated by reference in ARTICLE I.3. of this
solicitation. Qualified HUBZone firms are identified in the Small
Business Administration website at
[[http://www.sba.gov/hubzone]{.underline}](http://www.sba.gov/hubzone).

**(17)** **Extent of Small Disadvantaged Business Participation**

In accordance with FAR Subpart 15.304(c)(4), the extent of participation
of Small Disadvantaged Business (SDB) concerns in performance of the
contract in the authorized NAICS Subsectors shall be evaluated in
unrestricted competitive acquisitions expected to exceed \$500,000
(\$1,000,000 for construction) subject to certain limitations (see FAR
19.1202-1 and 19.1202-2(b). The dollar amounts cited above include any
option years/option quantities that may be included in this
solicitation. The definition of a \"small disadvantaged business\" is
cited in FAR 19.001.

The factor entitled "Extent of Small Disadvantaged Business
Participation" as set forth under the Evaluation Criteria in Section M
shall be used for evaluation purposes.

The Department of Commerce determines, on an annual basis, by
Subsectors, as contained in the North American Industry Classification
System (NAICS) code, and region, if any, the authorized SDB procurement
mechanisms and applicable factors (percentages). The NAICS codes can be
found at:

[[http://www.sba.gov/size]{.underline}](http://www.sba.gov/size)

The Department of Commerce website for the annual determination for
NAICS codes\* is:

[[http://www.arnet.gov/References/sdbadjustments.htm]{.underline}](http://www.arnet.gov/References/sdbadjustments.htm).

\**Note: Public Law 103-355 which authorized the SDB Price Evaluation
Adjustment (PEA) and associated percentages/factors expired on December
9, 2004, therefore, the percentages shown at this website are no longer
applicable.*

Offerors shall include with their offers, SDB targets, expressed as
dollars and percentages of total contract value, in each of the
applicable, authorized NAICS Subsector(s). The applicable authorized
NAICS Subsector(s) for this project is (are) identified elsewhere in
this RFP. A total target for SDB participation by the prime contractor,
that includes any joint ventures and team members, shall be provided as
well as a total target for SDB participation by subcontractors. In
addition, offerors must provide information that describes their plans
for meeting the targets set forth in their proposal. **This information
shall be provided in one clearly marked section of the Business
Proposal, which shall describe the extent of participation of SDB
concerns in the performance of the contract.**

If the evaluation factor in this solicitation includes an SDB evaluation
factor or subfactor that considers the extent to which SDB concerns are
specifically identified, the SDB concerns considered in the evaluation
shall be listed in any resultant contract. Offerors should note that
addressing the extent of small disadvantaged business participation **is
not in any way intended to be a substitute** for submission of the
subcontracting plan, if it is required by this solicitation. An
[example]{.underline} of the type of information that might be given (in
addition to the narrative describing the plan for meeting the targets)
follows:

  -----------------------------------------------------------------------
  EXAMPLE

  Targets for SDB Participation - NAICS Subsector 223
  -----------------------------------------------------------------------

+-----------------------------+---------------------+------------------+
|                             | **SDB Percentage    | **SDB Dollars**  |
|                             | of**                |                  |
|                             |                     |                  |
|                             | **Total Contract    |                  |
|                             | Value**             |                  |
+-----------------------------+---------------------+------------------+
| Total Contract Value-       | 25%                 | \$250,000        |
| \$1,000,000                 |                     |                  |
+-----------------------------+---------------------+------------------+
| SDB Participation by Prime  | 10%                 | \$100,000        |
+-----------------------------+---------------------+------------------+
| (Includes joint venture     |                     |                  |
| partners and team           |                     |                  |
| arrangements)\*             |                     |                  |
+-----------------------------+---------------------+------------------+
| SDB Participation by        | 15%                 | \$150,000        |
| subcontractors              |                     |                  |
+-----------------------------+---------------------+------------------+

\*Note: FAR Subpart 9.6 defines "Contractor team arrangements" to
include two or more companies forming a partnership or joint venture to
act as a potential prime contractor, or a potential prime contractor who
agrees with one or more companies to have them act as its subcontractors
on a specific contract or acquisition program. For purposes of
evaluation of the SDB participation factor, FAR 19.1202-4 requires that
SDB joint ventures and teaming arrangements at the prime level be
presented separately from SDB participation by subcontractors.

(18) **Salary Rate Limitation in Fiscal Year 2005**

> Offerors are advised that pursuant to P.L. 108-447, no NIH Fiscal Year
> 2005 (October 1, 2004 - September 30, 2005) funds may be used to pay
> the direct annual salary of an individual through any contract awarded
> as a result of this solicitation at a rate in excess of the Executive
> Schedule, Level I\* (direct salary is exclusive of Overhead, Fringe
> Benefits and General and Administrative expenses, also referred to as
> \"indirect cost\" or \"facilities and administrative (F&A) costs\").
> Direct salary has the same meaning as the term \"institutional base
> salary.\" An individual\'s direct salary (or institutional base
> salary) is the annual compensation that the contractor pays for an
> individual\'s appointment whether that individual\'s time is spent on
> research, teaching, patient care or other activities. Direct salary
> (or institutional base salary) excludes any income that an individual
> may be permitted to earn outside of duties to the contractor.

This does not preclude the offeror from absorbing that portion of an
employee\'s annual salary (plus the dollar amount for fringe benefits
and associated indirect costs) that exceeds a rate of the Executive
Schedule, Level I\*. The salary rate limitation set by P.L. 108-447
applies only to Fiscal Year 2005 funds, however, salary rate ceilings
for subsequent years may be included in future DHHS appropriation acts.
Multi-year contracts awarded pursuant to this solicitation may be
subject to unilateral modifications by the Government if an
individual\'s annual salary exceeds any salary rate ceiling established
in future appropriations acts. The Executive Schedule, Level I\* annual
salary rate limit also applies to individuals proposed under
subcontracts, however it does not apply to consultants. P.L. 108-447
states in pertinent part:

> \"None of the funds appropriated in this Act for the National
> Institutes of Health, the Agency for Healthcare Research and Quality,
> and the Substance Abuse, and Mental Health Services Administration
> shall be used to pay the salary of an individual through a grant or
> extramural mechanism at a rate in excess of Executive Level I\*.\"

**LINK TO EXECUTIVE SCHEDULE SALARIES:**
[[http://www.opm.gov/oca/05tables/html/ex.asp]{.underline}](http://www.opm.gov/oca/05tables/html/ex.asp)

> ***\*Note to Offerors:** The current Fiscal Year Executive Level I
> Salary Rate should be adhered to in the preparation of your proposal.
> All costs associated with any resultant contract award will be
> required to be in compliance with the current Fiscal Year 2005
> Executive Level I Salary rates.*

(19) **Institutional Responsibility Regarding Conflicting Interests of
     Investigators**

**EACH INSTITUTION MUST:**

\(a\) Maintain an appropriate written, enforced policy on conflict of
interest that complies with 42 CFR Part 50 Subpart F and/or 45 CFR Part
94 as appropriate and inform each investigator of the Institution\'s
policy, the Investigator\'s reporting responsibilities, and the
applicable regulations. If the Institution carries out the NIH funded
research through subgrantees, contractors or collaborators, the
Institution must take reasonable steps to ensure that Investigators
working for such entities comply with the regulations, either by
requiring those investigators to comply with the Institution\'s policy
or by requiring the entities to provide assurances to the Institution
that will enable the Institution to comply with the regulations.

\(b\) Designate an Institutional official(s) to solicit and review
financial disclosure statements from each Investigator who is planning
to participate in NIH-funded research.

\(c\) Require that by the time an application/proposal is submitted to
the NIH each investigator who is planning to participate in the
NIH-funded research has submitted to the designated official(s) a
listing of his/her known Significant Financial Interests (and those of
his/her spouse and dependent children): (i) that would reasonably appear
to be affected by the research for which the NIH funding is sought; and
(ii) in entities whose financial interests would reasonably appear to be
affected by the research. All financial disclosures must be updated
during the period of the award, either on an annual basis or as new
reportable Significant Financial Interests are obtained.

\(d\) Provide guidelines consistent with the regulations for the
designated official(s) to identify conflicting interests and take such
actions as necessary to ensure that such conflicting interests will be
managed, reduced, or eliminated.

\(e\) Maintain records, identifiable to each award, of all financial
disclosures and all actions taken by the institution with respect to
each conflicting interest for: (1) in the case of grants, at least three
years from the date of submission of the final expenditures report or,
where applicable, from other dates specified in 45 CFR Part 74.53(b) and
(2) in the case of contracts, 3 years after final payment or, where
applicable, for the other time period specified in 48 CFR Part 4 Subpart
4.7, Contract Records Retention.

\(f\) Establish adequate enforcement mechanisms and provide for
sanctions where appropriate.

\(g\) Certify, in each application/proposal for funding to which the
regulations applies, that:

1\) there is in effect at the Institution a written and enforced
administrative process to identify and manage, reduce or eliminate
conflicting interests with respect to all research projects for which
funding is sought from the NIH;

2\) prior to the Institution\'s expenditure of any funds under the
award, the Institution will report to the awarding component the
existence of a conflicting interest (but not the nature of the interest
or other details) found by the Institution and assure that the interest
has been managed, reduced or eliminated in accord with the regulations;
and for any interest that the Institution identifies as conflicting
subsequent to the expenditure of funds after award, the report will be
made and the conflicting interest managed, reduced, or eliminated, at
least on a temporary basis within sixty days of that identification;

3\) the Institution agrees to make information available, upon request,
to the awarding component regarding all conflicting interests identified
by the Institution and how those interested have been managed, reduced,
or eliminated to protect the research from bias; and

4\) the Institution will otherwise comply with the regulations.

**Institutional Management of Conflicting Interests**

\(a\) The designated official(s) must: (1) review all financial
disclosures; and (2) determine whether conflict of interest exists, and
if so, determine what actions should be taken by the Institution to
manage, reduce or eliminate such conflict of interest. **A conflict of
interest exists when the designated official(s) reasonably determines
that a Significant Financial Interest could directly and significantly
affect the design, conduct, or reporting of the NIH-funded research**.

Examples of conditions or restrictions that might be imposed to manage
actual or potential conflicts of interests include, but are not limited
to:

> \(i\) public disclosure of significant financial interests;
>
> \(ii\) monitoring of research by independent reviewers;
>
> \(iii\) modification of the research plan;
>
> \(iv\) disqualification of the Investigator(s) from participation in
> all or a portion of the research funded by the awarding component;
>
> \(v\) divestiture of significant financial interests; or
>
> \(vi\) severance of relationships that create actual or potential
> conflicts of interests.

\(b\) An Institution may require the management of other conflicting
financial interests in addition to those described in paragraph (a) of
this section, as the Institution deems appropriate.

**(20)** **ROTC Access and Federal Military Recruiting on Campus**

Section 514 of the FY 1997 Appropriations Act prohibits NIH from
providing contract funds to educational institutions that the Secretary
of Defense determines have a policy or practice (regardless of when
implemented ) that either prohibits, or in effect prevents (1) the
maintaining, establishing, or operation of a unit of the Senior Reserve
Officer Training Corps at the covered education entity; or (2) a student
at the covered educational entity from enrolling in a unit of the Senior
Reserve Officer Training Corps at another institution of higher
education.

Further, contract funds may not be provided to educational institutions
that have a policy or practice that prohibits or prevents (1) entry to
campuses, or access to students (who are 17 years of age or older) on
campuses, for purposes of Federal military recruiting; or (2) access by
military recruiters for purposes of Federal military recruiting to
information pertaining to students (who are 17 years of age or older)
enrolled at the covered educational entity.

**(21)** **Past Performance Information**

a\) Offerors shall submit the following information as part of their
technical\] proposal.

A list of the last five contracts completed during the past three years
and the last five contracts currently in process that are similar in
nature to the solicitation workscope. Contracts listed may include those
entered into by the Federal Government, agencies of state and local
governments and commercial concerns. Offerors that are newly formed
entities without prior contracts should list contracts and subcontracts
as required above for all key personnel.

Include the following information for each contract or subcontract:

> 1\. Name of Contracting Organization
>
> 2\. Contract Number (for subcontracts, provide the prime contract
> number and the subcontract number)
>
> 3\. Contract Type
>
> 4\. Total Contract Value
>
> 5\. Description of Requirement
>
> 6\. Contracting Officer\'s Name and Telephone Number
>
> 7\. Program Manager\'s Name and Telephone Number
>
> 8\. Standard Industrial Code

The offeror shall submit comparable information on all subcontractors
that the offeror proposes to perform a major subcontract under this
effort. For the purpose of this solicitation, a \"major subcontract\" is
defined as greater than \$500,000 over the seven years of the contract.

The offeror may provide information on problems encountered on the
identified contracts and the offeror\'s corrective actions.

b\) Each offeror will be evaluated on its performance under existing and
prior contracts for similar products or services. The Government is not
required to contact all references provided by the offeror. Also,
references other than those identified by the offeror may be contacted
by the Government to obtain additional information that will be used in
the evaluation of the offeror\'s past performance.

(22) **Electronic and Information Technology Accessibility**

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as
amended by P.L.105-220 under Title IV (Rehabilitation Act Amendments of
1998) and the Architectural and Transportation Barriers Compliance Board
Electronic and Information Technology (EIT) Accessibility Standards (36
CFR part 1194) require that all EIT acquired must ensure that:

a\. Federal employees with disabilities have access to and use of
information and data that is comparable to the access and use by Federal
employees who are not individuals with disabilities; and

b\. Members of the public with disabilities seeking information or
services from an agency have access to and use of information and data
that is comparable to the access to and use of information and data by
members of the public who are not individuals with disabilities.

This requirement includes the development, maintenance, and/or use of
EIT products/services, therefore, any proposal submitted in response to
this solicitation must demonstrate compliance with the established EIT
Accessibility Standards.

Further information about Section 508 is available via the Internet at
[[http://www.section508.gov]{.underline}](http://www.section508.gov/) .

**(23) Prohibition on Contractor Involvement with Terrorist Activities**

> The contractor acknowledges that U.S. Executive Orders and Laws,
> including but not limited to E.O. 13224 and P.L. 107-56, prohibit
> transactions with, and the provision of resources and support to,
> individuals and organizations associated with terrorism. It is the
> legal responsibility of the contractor to ensure compliance with these
> Executive Orders and Laws. This clause must be included in all
> subcontracts issued under this contract.

(24) **Solicitation Provisions Incorporated by Reference, FAR 52.252-1
     (February 1998)**

> This Solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions
> may include blocks that must be completed by the offeror and submitted
> with its quotation or offer. In lieu of submitting the full text
> provisions, the offeror may identify the provision by paragraph
> identifier and provide the appropriate information with its quotation
> or offer. Also, the full text of a solicitation provision may be
> accessed electronically at this address:
> [[http://www.arnet.gov/far/]{.underline}](http://www.arnet.gov/far/).
>
> FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1):

a)  Data Universal Numbering System (DUNS) Number, FAR Clause 52.204-6
    (October 2003).

b)  Facilities Capital Cost of Money, FAR Clause 52.215-16, (October
    1997).

c)  Order of Precedence-Uniform Contract Format, FAR Clause 52.215-8,
    (October 1997).

d)  Preaward On-Site Equal Opportunity Compliance Evaluation, (Over
    \$10,000,000), FAR Clause

52.222-24, (February 1999).

b\. TECHNICAL PROPOSAL INSTRUCTIONS

> []{#LTECHPROPOSAL .anchor}A detailed work plan must be submitted
> indicating how each aspect of the statement of work is to be
> accomplished. Your technical approach should be in as much detail as
> you consider necessary to fully explain your proposed technical
> approach or method. The technical proposal should reflect a clear
> understanding of the nature of the work being undertaken. The
> technical proposal must include information on how the project is to
> be organized, staffed, and managed. Information should be provided
> which will demonstrate your understanding and management of important
> events or tasks.

(1) **Technical Discussions**

> The technical discussion included in the technical proposal should
> respond to the items set forth below:

a\) **Project Objectives, NIH-1688-1**

The offeror shall insert a completed NIH Form 1688-1, Project Objective,
as provided in Section J, Attachments, behind the Title Page of each
copy of the proposal, along with the "Government Notice for Handling
Proposals." The NIH Form 1688-1 is to be completed as follows:

\- For an **Institution of Higher Education:** The form
[MUST]{.underline} be completed in its entirety.

\- For **OTHER** than an Institution of Higher Education: The starred
items (Department, Service, Laboratory or Equivalent, and Major
Subdivision) should be left blank.

The information required under the "Summary of Objectives" portion of
the form MUST meet the requirements set forth in the section of the form
entitled, **"[INSTRUCTIONS]{.underline}:"**

b\) **Statement of Work**

> \(1\) Objectives
>
> State the overall objectives and the specific accomplishments you hope
> to achieve. Indicate the rationale for your plan, and relation to
> comparable work in progress elsewhere. Review pertinent work already
> published which is relevant to this project and your proposed
> approach. This should support the scope of the project as you perceive
> it.

\(2\) Approach

> Use as many subparagraphs, appropriately titled, as needed to clearly
> outline the general plan of work. Discuss phasing of research and, if
> appropriate, include experimental design and possible or probable
> outcome of approaches proposed.
>
> \(3\) Methods
>
> Describe in detail the methodologies you will use for the project,
> indicating your level of experience with each, areas of anticipated
> difficulties, and any unusual expenses you anticipate.
>
> \(4\) Schedule
>
> Provide a schedule for completion of the work and delivery of items
> specified in the statement of work. Performance or delivery schedules
> shall be indicated for phases or segments, as applicable, as well as
> for the overall program. Schedules shall be shown in terms of calendar
> months from the date of authorization to proceed or, where applicable,
> from the date of a stated event, as for example, receipt of a required
> approval by the Contracting Officer. Unless the request for proposal
> indicates that the stipulated schedules are mandatory, they shall be
> treated as desired or recommended schedules. In this event, proposals
> based upon the offeror\'s best alternative schedule, involving no
> overtime, extra shift or other premium, will be accepted for
> consideration.
>
> c\) **Personnel**
>
> Describe the experience and qualifications of personnel who will be
> assigned for direct work on this program. Information is required
> which will show the composition of the task or work group, its general
> qualifications, and recent experience with similar equipment or
> programs. Special mention shall be made of direct technical
> supervisors and key technical personnel, and the approximate
> percentage of the total time each will be available for this program.

**OFFERORS SHOULD ASSURE THAT THE PRINCIPAL INVESTIGATOR, AND ALL OTHER
PERSONNEL PROPOSED, SHALL NOT BE COMMITTED ON FEDERAL GRANTS AND
CONTRACTS FOR MORE THAN A TOTAL OF 100% OF THEIR TIME. IF THE SITUATION
ARISES WHERE IT IS DETERMINED THAT A PROPOSED EMPLOYEE IS COMMITTED FOR
MORE THAN 100% OF HIS OR HER TIME, THE GOVERNMENT WILL REQUIRE ACTION ON
THE PART OF THE OFFEROR TO CORRECT THE TIME COMMITMENT.**

> \(1\) Principal Investigator/Project Director
>
> List the name of the Principal Investigator/Project Director
> responsible for overall implementation of the contract and key contact
> for technical aspects of the project. Even though there may be
> co-investigators, identify the Principal Investigator/Project Director
> who will be responsible for the overall implementation of any awarded
> contract. Discuss the qualifications, experience, and accomplishments
> of the Principal Investigator/Project Director. State the estimated
> time to be spent on the project, his/her proposed duties, and the
> areas or phases for which he/she will be responsible.
>
> \(2\) Other Investigators
>
> List all other investigators/professional personnel who will be
> participating in the project. Discuss the qualifications, experience,
> and accomplishments. State the estimated time each will spend on the
> project, proposed duties on the project, and the areas or phases for
> which each will be responsible.
>
> \(3\) Additional Personnel
>
> List names, titles, and proposed duties of additional personnel, if
> any, who will be required for full-time employment, or on a
> subcontract or consultant basis. The technical areas, character, and
> extent of subcontract or consultant activity will be indicated and the
> anticipated sources will be specified and qualified. For all proposed
> personnel who are not currently members of the offeror\'s staff, a
> letter of commitment or other evidence of availability is required. A
> resume does not meet this requirement. Commitment letters for use of
> consultants and other personnel to be hired must include:

-The specific items or expertise they will provide.

-Their availability to the project and the amount of time anticipated.

-Willingness to act as a consultant.

-How rights to publications and patents will be handled.

> \(4\) Resumes
>
> Resumes of all key personnel are required. Each must indicate
> educational background, recent experience, specific or technical
> accomplishments, and a listing of relevant publications.

a.  The technical proposal should include the information described in
    **Appendix A, Additional Technical Proposal Instructions.**

```{=html}
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(2) **Technical Evaluation**

Proposals will be technically evaluated in accordance with the factors,
weights, and order of relative importance as described in the Technical
Evaluation Criteria (Section M.5, hereof).

(3) **Additional Technical Proposal Information**

> a\) Proposals which merely offer to conduct a program in accordance
> with the requirements of the Government\'s scope of work will not be
> eligible for award. The offeror must submit an explanation of the
> proposed technical approach in conjunction with the tasks to be
> performed in achieving the project objectives.
>
> b\) The technical evaluation is conducted in accordance with the
> weighted technical evaluation criteria by an initial review panel.
> This evaluation produces a numerical score (points) which is based
> upon the information contained in the offeror\'s proposal only.

(4) **Other Considerations**

> Record and discuss specific factors not included elsewhere which
> support your proposal. Using specifically titled subparagraphs, items
> may include:

a\) Any agreements and/or arrangements with subcontractor(s). Provide as
much detail as necessary to explain how the statement of work will be
accomplished within this working relationship.

> b\) Unique arrangements, equipment, etc., which none or very few
> organizations are likely to have which is advantageous for effective
> implementation of this project.
>
> c\) Equipment and unusual operating procedures established to protect
> personnel from hazards associated with this project.

d\) Other factors you feel are important and support your proposed
research.

> e\) Recommendations for changing reporting requirements if such
> changes would be more compatible with the offeror\'s proposed
> schedules.
>
> **[IMPORTANT NOTE TO OFFERORS]{.underline}: The following 12
> paragraphs \[(5) through (16)\] shall be addressed in a SEPARATE
> SECTION of the Technical Proposal entitled, \"HUMAN SUBJECTS.\"**

(5) **Human Subjects**

> The following notice is applicable when contract performance is
> expected to involve risk to human subjects:
>
> **Notice to Offerors of Requirements of 45 CFR Part 46, Protection of
> Human Subjects (MARCH 2005)**
>
> \(a\) Copies of the Department of Health and Human Services
> (Department) regulations for the protection of human subjects, 45 CFR
> Part 46, are available from the Office for Human Research Protections
> (OHRP), Bethesda, Maryland 20892. The regulations provide a systematic
> means, based on established ethical principles, to safeguard the
> rights and welfare of individuals who participate as subjects in
> research activities supported or conducted by the Department.

\(b\) The regulations define a human subject as a living individual
about whom an investigator (whether professional or student) conducting
research obtains data through intervention or interaction with the
individual, or identifiable private information. The regulations extend
to the use of human organs, tissue, and body fluids from individually
identifiable human subjects as well as to graphic, written, or recorded
information derived from individually identifiable human subjects. The
use of autopsy materials is governed by applicable State and local law
and is not directly regulated by 45 CFR Part 46.

\(c\) Activities in which the only involvement of human subjects will be
in one or more of the categories set forth in 45 CFR 46.101(b)(1-6) are
exempt from coverage.

\(d\) Inappropriate designations of the noninvolvement of human subjects
or of exempt categories of research in a project may result in delays in
the review of a proposal. The OpDiv will make a final determination of
whether the proposed activities are covered by the regulations or are in
an exempt category, based on the information provided in the proposal.
In doubtful cases, prior consultation with OHRP, (telephone:
301-496-7005), is recommended.

\(e\) In accordance with 45 CFR Part 46, prospective Contractors being
considered for award shall be required to file with OHRP an acceptable
Assurance of Compliance with the regulations, specifying review
procedures and assigning responsibilities for the protection of human
subjects. The initial and continuing review of a research project by an
institutional review board shall assure that the rights and welfare of
the human subjects involved are adequately protected, that the risks to
the subjects are reasonable in relation to the potential benefits, if
any, to the subjects and the importance of the knowledge to be gained,
and that informed consent will be obtained by methods that are adequate
and appropriate. The contracting officer will direct the
offeror/contractor to the OHRP IRB Registration and Assurance Filing
website, found at
[[http://www.hhs.gov/ohrp/]{.underline}](http://www.hhs.gov/ohrp/) or to
the physical address if the offeror/contractor cannot access the
Internet. HHS regulations for the protection of human subjects may be
found at:

[[http://www.access.gpo.gov/nara/cfr/waisidx_01/45cfr46_01.html]{.underline}](http://www.access.gpo.gov/nara/cfr/waisidx_01/45cfr46_01.html)

\(f\) It is recommended that OHRP be consulted for advice or guidance
concerning either regulatory requirements or ethical issues pertaining
to research involving human subjects.

(End of provision)

(6) **Instructions to Offerors Regarding Protection of Human Subjects**

> Offerors must address the following human subjects protections issues
> if this contract will be for research involving human subjects (note:
> under each of the following points below, the offeror should indicate
> whether the information provided relates to the primary research site,
> or to a collaborating performance site(s), or to all sites:

\(a\) Risks to the subjects

> Human Subjects Involvement and Characteristics:

**-** Describe the proposed involvement of human subjects in response to
the solicitation.

> **-** Describe the characteristics of the subject population,
> including their anticipated number, age range, and health status.
>
> **-** Identify the criteria for inclusion or exclusion of any
> subpopulation. Explain the rationale for the involvement of special
> classes of subjects, such as fetuses, pregnant women, children,
> prisoners, institutionalized individuals, or others who are likely to
> be vulnerable populations.

Sources of Materials:

> **-** Identify the sources of research material obtained from
> individually identifiable living human subjects in the form of
> specimens, records, or data. Indicate whether the material or data
> will be obtained specifically for research purposes or whether use
> will be made of existing specimens, records, or data.

Potential Risks:

> **-** Describe the potential risks to subjects (physical,
> psychological, social, legal, or other) and assess their likelihood
> and seriousness to the subjects.
>
> **-** Describe alternative treatments and procedures, including the
> risks and benefits of the alternative treatments and procedures, to
> participants in the proposed research, where appropriate.
>
> \(b\) Adequacy of Protection Against Risks
>
> Recruitment and Informed Consent:
>
> **-** Describe plans for the recruitment of subjects and the
> procedures for obtaining informed consent. Include a description of
> the circumstances under which consent will be sought and obtained, who
> will seek it, the nature of the information to be provided to
> prospective subjects, and the method of documenting consent. The
> informed consent document for the contractor and any collaborating
> sites should be submitted only if requested elsewhere in the
> solicitation. Be aware that an IRB-approved informed consent document
> for the contractor and any participating collaborative sites must be
> provided to the Government prior to patient accrual or participant
> enrollment.
>
> Protection Against Risk:
>
> **-** Describe the procedures for protecting against or minimizing
> potential risks, including risks to confidentiality, and assess their
> likely effectiveness.
>
> **-** Discuss provisions for ensuring necessary medical or
> professional intervention in the event of adverse effects to the
> subjects where appropriate.
>
> **-** In studies that involve interventions, describe the provisions
> for data and safety monitoring of the research to ensure the safety of
> subjects.

\(c\) Potential Benefits of the Proposed Research to the Subjects and
Others

> **-** Discuss the potential benefits of the research to the subjects
> and others.
>
> **-** Discuss why the risks to subjects are reasonable in relation to
> the anticipated benefits to subjects and others.
>
> **-** Describe treatments and procedures that are alternatives to
> those provided to the participants by the proposed research, where
> appropriate.

\(d\) Importance of the Knowledge to be Gained

> **-** Discuss the importance of the knowledge gained or to be gained
> as a result of the proposed research.
>
> **-** Discuss why the risks to subjects are reasonable in relation to
> the importance of the knowledge that may reasonably be expected to
> result.

**Note:** If a test article (investigational new drug, device, or
biologic) is involved, name the test article and state whether the
30-day interval between submission of offeror's certification to the
Food and Drug Administration (FDA) and its response has elapsed or has
been waived and/or whether the FDA has withheld or restricted use of the
test article.

**Collaborating Site(s)**

When research involving human subjects will take place at collaborating
site(s) or other performance site(s), the offeror must provide in this
section of its proposal a list of the collaborating sites and their
assurance numbers. Further, if you are awarded a contract, you must
obtain in writing, and keep on file, an assurance from each site that
the previous points have been adequately addressed at a level of
attention that is at least as high as that documented at your
organization. Site(s) added after an award is made must also adhere to
the above requirements.

(7) **Required Education in the Protection of Human Research
    Participants**

NIH policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
contracts for research involving human subjects. This policy
announcement is found in the [NIH Guide for Grants and
Contracts](http://grants.nih.gov/grants/guide/index.html) Announcement
dated June 5, 2000 at the following website:
[[http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html).
Offerors should review the policy announcement prior to submission of
their offers. The following is a summary of the Policy Announcement:

For any solicitation for research involving human subjects, the offeror
shall provide in its technical proposal the following information: (1) a
list of the names of the principal investigator and any other
individuals proposed under the contract who are responsible for the
design and/or conduct of the research; (2) the title of the education
program completed (or to be completed prior to the award of the
contract) for each named personnel; (3) a one sentence description of
the program(s) listed in (2) above. This requirement extends to
investigators and all individuals responsible for the design and/or
conduct of the research who are working as subcontractors or consultants
under the contract.

Curricula that are readily available and meet the educational
requirement include the NIH on-line tutorial, titled "Protection of
Human Research Subjects: Computer-Based Training for Researchers,"
available at
[[http://ohsr.od.nih.gov/cbt/]{.underline}](http://ohsr.od.nih.gov/cbt/).
You may download the information at this site at no cost and modify it,
if desired. The University of Rochester has made its training program
available for individual investigators. Completion of this program will
also satisfy the educational requirement. The University of Rochester
manual can be obtained through Centerwatch, Inc. at

[[http://www.centerwatch.com/order/pubs_profs_protect.html]{.underline}](http://www.centerwatch.com/).

In addition, the NCI sponsors an online training course at:

[[http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp]{.underline}](http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp).

If an institution already has developed educational programs on the
protection of research participants, completion of these programs also
will satisfy the educational requirement.

In addition, prior to the substitution of the principal investigator or
any other individuals responsible for the design and/or conduct of the
research under the contract, the contractor shall provide the
contracting officer with the title of the education program and a one
sentence description of the program that the replacement has completed.

(8) **Inclusion of Women and Minorities in Research Involving Human
    Subjects**

It is NIH policy that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects involving human subjects, unless a clear and compelling
rationale and justification establishes to the satisfaction of the
relevant Institute/Center Director that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research.
The Director, NIH, may determine that exclusion under other
circumstances is acceptable, upon the recommendation of an
Institute/Center Director, based on a compelling rationale and
justification. Cost is not an acceptable reason for exclusion except
when the study would duplicate data from other sources. Women of
childbearing potential should not be routinely excluded from
participation in clinical research. This policy results from the NIH
Revitalization Act of 1993 (Section 492B of Public Law 103-43), ***and
applies to research subjects of all ages***.

All investigators proposing research involving human subjects should
read the UPDATED \"NIH Policy and Guidelines on the Inclusion of Women
and Minorities as Subjects in Clinical Research, Amended October 2001,\"
published in the NIH Guide for Grants and Contracts on October 9, 2001
at the following web site:

[[http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm]{.underline}](http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm)

These guidelines contain a definition of **clinical research** adopted
in June 2001, as: \"(1) Patient-oriented research. Research conducted
with human subjects (or on material of human origin such as tissues,
specimens and cognitive phenomena) for which an investigator (or
colleague) directly interacts with human subjects. Excluded from this
definition are in vitro studies that utilize human tissues that cannot
be linked to a living individual. Patient-oriented research includes (a)
mechanisms of human disease, (b) therapeutic interventions, (c) clinical
trials, and (d) development of new technologies; (2) Epidemiologic and
behavioral studies; and (3) Outcomes research and health services
research,\" at:

([[http://www.nih.gov/news/crp/97report/execsum.htm]{.underline}](http://www.nih.gov/news/crp/97report/execsum.htm)).

> **Information Required for ALL Clinical Research Proposals**
>
> This solicitation contains a review criterion addressing the adequacy
> of: (1) the offeror's plans for inclusion of women and minorities in
> the research proposed; or (2) the offeror's justification(s) for
> exclusion of one or both groups from the research proposed.
>
> Provide information on the composition of the proposed study
> population in terms of sex/gender and racial/ethnic groups and provide
> a rationale for selection of such subjects in response to the
> requirements of the solicitation. The description may include (but is
> not limited to) information on the population characteristics of the
> disease or condition being studied in the planned research, and/or
> described in the statement of work, national and local demography,
> knowledge of the racial/ethnic/cultural characteristics of the
> population, prior experience and collaborations in recruitment and
> retention of the populations and subpopulations to be studied, and the
> plans, arrangements and letters of commitment from relevant community
> groups and organizations for the planned research.

The proposal must include the following information:

**-** A description of the subject selection criteria

> **-** The proposed dates of enrollment (beginning and end)

**-** A description of the proposed outreach programs for recruiting
women and minorities as subjects

**-** A compelling rationale for proposed exclusion of any sex/gender or
racial/ethnic group

> **-** The proposed sample composition using the "Targeted/Planned
> Enrollment Table"(see Section J, Attachments)
>
> ***NOTE 1:** For all proposals, use the ethnic and racial categories
> and complete the "Targeted/Planned Enrollment Table in accordance with
> the Office of Management and Budget (OMB) Directive No. 15, which may
> be found at:
> [[http://www.whitehouse.gov/OMB/fedreg/ombdir15.html]{.underline}](http://www.whitehouse.gov/OMB/fedreg/ombdir15.html).*
>
> ***NOTE 2:** If this is an Indefinite Delivery, Indefinite Quantity
> (IDIQ) or Requirements contract as defined in FAR 16.5, the proposal
> should describe in general terms how it will comply with each bulleted
> item above for each task order. When the Government issues a task
> order request for proposal, each of the bulleted information items
> must be fully and specifically addressed in the proposal.*
>
> **Standards for Collecting Data.** When you, as a contractor, are
> planning data collection items on race and ethnicity, you shall use,
> at a minimum, the categories identified in OMB Directive No. 15. The
> collection of greater detail is encouraged. However, you should design
> any additional, more detailed items so that they can be aggregated
> into these required categories. Self-reporting or self-identification
> using two separate questions is the preferred method for collecting
> data on race and ethnicity. When you collect race and ethnicity
> separately, you must collect ethnicity first. You shall offer
> respondents the option of selecting one or more racial designations.
> When you collect data on race and ethnicity separately, you shall also
> make provisions to report the number of respondents in each racial
> category who are Hispanic or Latino. When you present aggregate data,
> you shall provide the number of respondents who selected only one
> category, for each of the five racial categories. If you collapse data
> on multiple responses, you shall make available, at a minimum, the
> total number of respondents reporting "more than one race." Federal
> agencies shall not present data on detailed categories if doing so
> would compromise data quality or confidentiality standards.

In addition to the above requirements, solicitations for **NIH defined
Phase III clinical trials**[^1] require that*:* a) all proposals and/or
protocols provide a description of plans to conduct analyses, as
appropriate, to detect significant differences in intervention effect
(see NIH Guide:

[[http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm]{.underline}](http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm),

Definitions - Significant Difference), by sex/gender, racial/ethnic
groups, and relevant subpopulations, if applicable; and b) all
contractors to report annually cumulative subject accrual, and progress
in conducting analyses for sex/gender and race/ethnicity differences.

> Offerors may obtain copies of the Updated Guidelines from the sources
> above or from the contact person listed in the solicitation.
>
> Also, the proposal must include one of the following plans:

\- Plans to conduct valid analysis to detect significant differences in
intervention effect among sex/gender and/or racial/ethnic subgroups when
prior studies strongly support these significant differences among
subgroups, OR

\- Plans to include and analyze sex/gender and/or racial/ethnic
subgroups when prior studies strongly support no significant differences
in intervention effect between subgroups, OR

\- Plans to conduct valid analyses of the intervention effect in
sex/gender and/or racial/ethnic subgroups (without requiring high
statistical power for each subgroup) when the prior studies neither
support nor negate significant differences in intervention effect
between subgroups.

> **Use the form entitled, \"Targeted/Planned Enrollment Table,\" when
> [preparing your response]{.underline} to the solicitation requirements
> for inclusion of women and minorities.** **(See Section J-List of
> Documents, Exhibits and Other Attachments of the RFP)**

Unless otherwise specified in this solicitation, the Government has
determined that the work required by this solicitation does not involve
a sex/gender specific study or a single or limited number of minority
population groups. Therefore, the NIH believes that the inclusion of
women and minority populations is appropriate for this project. (See
Section M of this RFP for more information about evaluation factors for
award.)

**Use the form entitled, \"Inclusion Enrollment Report,\" for [reporting
in the resultant contract]{.underline}.**

(9) **Inclusion of Children in Research Involving Human Subjects**

It is NIH policy that children (defined below) must be included in all
human subjects research, including, but not limited to, clinical trials,
conducted under a contract funded by the NIH, unless there are *clear
and compelling* reasons not to include them. (See examples of
Justifications for Exclusion of Children below). For the purposes of
this policy, contracts involving human subjects include categories that
would otherwise be exempt from the DHHS Policy for Protection of Human
Research Subjects (sections 101(b) and 401(b) of 45 CFR 46), such as
surveys, evaluation of educational interventions, and studies of
existing data or specimens that should include children as participants.
This policy applies to both domestic and foreign research contracts.

For purposes of this policy, a child is defined as an individual under
the age of 21 years.

> All offerors proposing research involving human subjects should read
> the \"NIH Policy and Guidelines on the Inclusion of Children as
> Participants in Research Involving Human Subjects\" which was
> published in the NIH Guide for Grants and Contracts on March 6, 1998
> and is available at the following URL address:

[[http://www.nih.gov/grants/guide/notice-files/not98-024.html]{.underline}](http://www.nih.gov/grants/guide/notice-files/not98-024.html)

Offerors also may obtain copies from the contact person listed in the
RFP.

Inclusion of children as participants in research must be in compliance
with all applicable subparts of 45 CFR 46 as well as other pertinent
laws and regulations whether or not such research is otherwise exempted
from 45 CFR 46. Therefore, any proposals must include a description of
plans for including children, unless the offeror presents clear and
convincing justification for an exclusion. The "Human Subjects" section
of your technical proposal should provide either a description of the
plans to include children and a rationale for selecting or excluding a
specific age range of child, or an explanation of the reason(s) for
excluding children as participants in the research. This solicitation
contains a review criterion addressing the adequacy of: (1) the plans
for including children as appropriate for the scientific goals of the
research; and/or (2) the justification of exclusion of children or
exclusion of a specific age range of children.

> When children are included, the plan also must include a description
> of: (1) the expertise of the investigative team for dealing with
> children at the ages included; (2) the appropriateness of the
> available facilities to accommodate the children; and, (3) the
> inclusion of a sufficient number of children to contribute to a
> meaningful analysis relative to the purpose/objective of the
> solicitation.
>
> **Justifications for Exclusion of Children**
>
> It is expected that children will be included in all research
> involving human subjects unless one or more of the following
> exclusionary circumstances can be fully justified:

**-** The objective of the solicitation is not relevant to children.

**-** There are laws or regulations barring the inclusion of children in
the research to be conducted under the solicitation.

**-** The knowledge being sought in the research is already available
for children or will be obtained from another ongoing study, and an
additional study will be redundant. You should provide documentation of
other studies justifying the exclusion.

**-** A separate, age-specific study in children is warranted and
preferable. Examples include:

**-** The relative rarity of the condition in children, as compared with
adults (in that extraordinary effort would be needed to include
children); or

**-** The number of children is limited because the majority are already
accessed by a nationwide pediatric disease research network; or

**-** Issues of study design preclude direct applicability of hypotheses
and/or interventions to both adults and children (including different
cognitive, developmental, or disease stages of different age-related
metabolic processes); or

**-** Insufficient data are available in adults to judge potential risk
in children (in which case one of the research objectives could be to
obtain sufficient adult data to make this judgment). While children
usually should not be the initial group to be involved in research
studies, in some instances, the nature and seriousness of the illness
may warrant their participation earlier based on careful risk and
benefit analysis; or

**-** Study designs aimed at collecting additional data on pre-enrolled
adult study subjects (e.g., longitudinal follow-up studies that did not
include data on children);

**-** Other special cases justified by the offeror and found acceptable
to the review group and the Institute Director

**Definition of a Child**

> For the purpose of this solicitation, a child is defined as an
> individual under the age of 21 years.
>
> The definition of child described above will pertain to this
> solicitation (notwithstanding the FDA definition of a child as an
> individual from infancy to 16 years of age, and varying definitions
> employed by some states). Generally, State laws define what
> constitutes a "child," and such definitions dictate whether or not a
> person can legally consent to participate in a research study.
> However, State laws vary, and many do not address when a child can
> consent to participate in research. Federal Regulations (45 CFR 46,
> subpart D, Sec.401-409) address DHHS protections for children who
> participate in research, and rely on State definitions of "child" for
> consent purposes. Consequently, the children included in this policy
> (persons under the age of 21) may differ in the age at which their own
> consent is required and sufficient to participate in research under
> State law. For example, some states consider a person age 18 to be an
> adult and therefore one who can provide consent without parental
> permission.

(10) **Data and Safety Monitoring in Clinical Trials**

All offerors are directed to the full text of the NIH Policies regarding
Data and Safety Monitoring and Reporting of Adverse Events that are
found in the [NIH Guide for Grants and Contracts
Announcements](http://grants.nih.gov/grants/guide/index.html) at the
following web sites:

[[http://grants.nih.gov/grants/guide/notice-files/not98-084.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/not98-084.html)

[[http://grants.nih.gov/grants/guide/notice-files/not99-107.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/not99-107.html)

[[http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html#http://grants.nih.gov/grants/guide/notice-files/NOH-OD-00-03)

All offerors receiving an award under this solicitation must comply with
the NIH Policy cited in these NIH Announcements and any other data and
safety monitoring requirements found elsewhere in this solicitation.

The following is a brief summary of the Data and Safety Monitoring and
Adverse Event Reporting Requirements:

Data and Safety Monitoring is required for every clinical trial.
Monitoring must be performed on a regular basis and the conclusions of
the monitoring reported to the Project Officer.

The type of data and safety monitoring required will vary based on the
type of clinical trial and the potential risks, complexity and nature of
the trial. A plan for data and safety monitoring is required for all
clinical trials. A general description of a monitoring plan establishes
the overall framework for data and safety monitoring. It should describe
the entity that will be responsible for the monitoring, and the policies
and procedures for adverse event reporting. Phase III clinical trials
generally require the establishment of a Data Safety Monitoring Board
(DSMB). The establishment of a DSMB is optional for Phase I and Phase II
clinical trials.

The DSMB/Plan is established at the time the protocol is developed and
must be approved by both the Institutional Review Board (IRB) and the
Government and in place before the trial begins. If the protocol will be
developed under the contract awarded from this solicitation, a general
description of the data and safety monitoring plan must be submitted as
part of the proposal and will be reviewed by the scientific review group
(Technical Evaluation Panel, (TEP)) convened to evaluate the proposal.
If the protocol is developed and is included as part of the submitted
proposal, a complete and specific data and safety monitoring plan must
be submitted as part of the proposal.

Monitoring Plans, at a minimum, must include the prompt reporting of
adverse events to the IRB, the NIH Office of Biotechnology Activities
(OBA), and the Food and Drug Administration (FDA). Also, in the plan you
should describe the frequency of reporting of the conclusions of the
monitoring activities. The overall elements of each plan may vary
depending on the size and complexity of the trial. The NIH Policy for
Data and Safety Monitoring at
[[http://grants.nih.gov/grants/guide/notice-files/not98-084.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/not98-084.html)
describes examples of monitoring activities to be considered.

> The frequency of monitoring will depend upon potential risks,
> complexity, and the nature of the trial; therefore a number of options
> for monitoring trials are available. These can include, but are not
> limited to, monitoring by a:

**-** Principal Investigator (required)

**-** Independent individual /Safety Officer

**-** Designated medical monitor

**-** Internal Committee or Board with explicit guidelines

**-** Data and Safety Monitoring Board (DSMB - required for multisite
trials)

**-** Institutional Review Board (IRB - required)

For multi-site Phase I and Phase II trials, a central reporting entity
that will be responsible for preparing timely summary reports of adverse
events for distribution among sites and IRBs should be considered.

Organizations with a large number of clinical trials may develop
standard monitoring plans for Phase I and Phase II trials. In this case,
such organizations may include the IRB-approved monitoring plan as part
of the proposal submission.

(11) **Research Involving Human Fetal Tissue**

Human Fetal Tissue means tissue or cells obtained from a dead human
fetus, including human embryonic stem cells, human pluripotent stem
cells and human embryonic germ cells.

The governing federal statute is the Public Health Service Act, 42
U.S.C. 289g-1 and 289g-2. Implementing regulations and guidance for
conducting research on human fetal tissue may be found at 45 CFR 46,
Subpart B and
[[http://grants1.nih.gov/grants/guide/notice-files/not93-235.html]{.underline}](http://grants1.nih.gov/grants/guide/notice-files/not93-235.html)
and any subsequent revisions to this NIH Guide to Grants and Contracts
(\"Guide\") Notice.

By signing the face page of the proposal, the offeror (authorized
institutional official) certifies that researchers using human fetal
tissue are in compliance with 42 USC 289g-2. This statute specifically
prohibits any person from knowingly acquiring, receiving, or
transferring any human fetal tissue for valuable consideration.
\"Valuable consideration\" is a concept similar to profit, and does not
include reasonable payment for costs associated with the collection
processing, preservation, storage, quality control or transportation of
these tissues.

Research involving the transplantation of human fetal tissue must be
conducted in accordance with applicable Federal, State and local law.

(12) **Research Involving Prisoners as Subjects**

a\. HHS Regulations at 45 CFR Part 46, Subpart C provide additional
protections pertaining to biomedical and behavioral research involving
prisoners or those individuals who, during the period of the contract
become prisoners, as subjects. These regulations also set forth the
duties of the Institutional Review Board (IRB) where prisoners are
involved in the research. HHS-funded research involving prisoners as
subjects may not proceed until the Office for Human Research Protections
(OHRP) issues approval, in writing, as required by 45 CFR 46.306(a)(2).
In addition, OHRP Guidance on the Involvement of Prisoners in Research
may be found at:

[[http://ohrp.osophs.dhhs.gov/humansubjects/guidance/prisoner.htm]{.underline}](http://ohrp.osophs.dhhs.gov/humansubjects/guidance/prisoner.htm)

b\. HHS Waiver for Epidemiological Research Involving Prisoners as
Subjects

On June 20, 2003 the Secretary of HHS waived the applicability of
certain provisions of Subpart C of 45 CFR Part 46, (Additional DHHS
Protections Pertaining to Biomedical and Behavioral Research Involving
Prisoners as Subjects) to specific types of epidemiological research
involving prisoners as subjects.

The applicability of 45 CFR 46.305(a)(1) and 46.306(a)(2) for certain
epidemiological research conducted or funded by DHHS is waived when:

1\. The sole purposes are:

a\) to describe the prevalence or incidence of a disease by identifying
all cases, or

b\) to study potential risk factor associations for a disease, and

2\. The Institution responsible for the conduct of the research
certifies to the OHRP that the Institutional Review Board (IRB) approved
the research and fulfilled its duties under 45 CFR 46.305(a)(2-7) and
determined and documented that:

a\) the research presents no more than minimal risk, and

b\) no more than inconvenience to the prisoner-subjects, and

c\) prisoners are not a particular focus of the research.

For more information about this Waiver see
[[http://www.hhs.gov/ohrp/special/prisoners/Prisoner waiver
6-20-03.pdf]{.underline}](http://www.hhs.gov/ohrp/special/prisoners/Prisoner)

(13) **Research Involving Recombinant DNA Molecules (including Human
     Gene Transfer Research)**

Recombinant DNA Molecules are either 1) molecules that are constructed
outside of living cells by joining natural or synthetic DNA segments to
DNA molecules that can replicate in a living cell, or 2) DNA molecules
that result from the replication of those described in 1).

The NIH Guidelines for Research Involving Recombinant DNA Molecules
([[http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html]{.underline}](http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html)
and the May 28, 2002 Notice, Compliance with the NIH Guidelines for
Research Involving Recombinant DNA Molecules, at:

([[http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-052.html]{.underline}](http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-052.html))

and any subsequent revisions to the Guide Notice) stipulates biosafety
and containment measures for recombinant DNA research and delineates
critical, ethical principles and key safety reporting requirements for
human gene transfer research (See Appendix M of the NIH Guidelines).
These guidelines apply to both basic and clinical research studies.

The Recombinant DNA Advisory Committee (RAC) is charged with the safety
of manipulation of genetic material through the use of recombinant DNA
techniques. Prior to beginning any clinical trials involving the
transfer of recombinant DNA to humans, the trial must be registered with
the RAC. If this contract involves new protocols that contain unique
and//or novel issues, the RAC must discuss them in a public forum and
then the Institutional Biosafety Committee (IBC), the Institutional
Review Board (IRB), and the project officer and contracting officer must
approve the protocol prior to the start of the research.

Failure to comply with these requirements may result in suspension,
limitation, or termination of NIH funding for any work related to
Recombinant DNA Research or a requirement for the contracting officer's
prior approval of any or all Recombinant DNA projects under any contract
awarded from this solicitation. This includes the requirements of the
Standing Institutional Biosafety Committee (IBC) (See
[[http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm]{.underline}](http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm)).

As specified in Appendix M-1-C-4 of the NIH Guidelines, any serious
adverse event must be reported immediately to the IRB, the IBC, the
Office for Human Research Protections (if applicable), and the NIH
Office for Biotechnology Activities (OBA), followed by the filing of a
written report with each office/group and copies to the project officer
and contracting officer.

([[http://www4.od.nih.gov/oba/rac/guidelines_02/Appendix_M.htm#\_Toc7255836]{.underline}](http://www4.od.nih.gov/oba/rac/guidelines_02/Appendix_M.htm#_Toc7255836))

(14) **Human Embryonic Germ Cell (HEGC) Research**

1\. [Guidelines]{.underline}.

Research use of human embryonic germ cells derived from fetal tissue
with Federal funds requires review of compliance with the NIH Guidelines
for Research Using Human Pluripotent Stem Cells
([[http://stemcells.nih.gov/policy/guidelines.asp]{.underline}](http://stemcells.nih.gov/policy/guidelines.asp))
(only the information regarding human embryonic germ cells is relevant).
Embryonic germ cells are pluripotent stem cells derived from human
embryos. See NIH Guide for Grants and Contracts Notice NOT-OD-02-049,
requiring that offerors/contractors submit certain documents to the
Human Pluripotent Stem Cell Review Group (HPSCRG), which will be
reviewed in a public meeting. Research using human embryonic germ cells
may not be performed prior to approval by the HPSCRG.

All offerors should read the \"NIH Guidelines\"
([[http://stemcells.nih.gov/policy/guidelines.asp]{.underline}](http://stemcells.nih.gov/policy/guidelines.asp))
if they either: (1) propose to respond to the Statement of Work
requirements by conducting research that uses human embryonic germ cells
or, (2) are responding to a Statement of Work that requires the use of
human embryonic germ cells.

Offerors may obtain copies of these Guidelines from the website above or
from the contact person listed in this solicitation.

2\. [Procedure for Review by Human Pluripotent Stem Cell Review Group
(HPSCRG)]{.underline}

If the offeror intends to fulfill the requirements of the Statement of
Work by performing research using human embryonic germ cells, it must so
state in its proposal.

If the offeror\'s proposal includes research using human embryonic germ
cells and it receives a contract award, the contractor may not perform
any research using these human embryonic germ cells until the Human
Pluripotent Stem Cell Review Group (HPSCRG) has reviewed and approved
the documentation furnished as prescribed in \"Procedures for Submission
of Compliance Documents to the Human Pluripotent Stem Cell Review Group
(HPSCRG) for the Research Use of Human Embryonic Germ Cells\"
([[http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-02-049.html]{.underline}](http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-02-049.html))
and the contracting officer has notified the contractor of the approval
in writing.

The resultant contract will be divided into discrete phases. During
Phase 1 of the contract, the contractor shall submit the original and
two copies of the required documentation and assurances that address the
areas covered in \"Procedures for Submission of Compliance Documents to
the Human Pluripotent Stem Cell Review Group (HPSCRG) for the Research
Use of Human Embryonic Germ Cells,\" at:

([[http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-02-049.html]{.underline}](http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-02-049.html))

to the contracting officer. This documentation will be forwarded for
review and approval to the HPSCRG.

If the HPSCRG disapproves the documentation presented by the contractor,
the Contracting Officer may elect to either terminate the contract in
accordance with the Termination for Convenience clause of the contract
OR determine not to exercise subsequent option(s) as appropriate based
the terms of the specific contract. Otherwise, when the HPSCRG approves
the documentation, the contracting officer will notify the contractor in
writing that research using the human embryonic germ cells may commence.

Research involving the use of human embryonic germ cells shall not be
conducted under the contract until the HPSCRG review and approval have
been obtained, and the contracting officer has provided written notice
of such approval to the contractor.

(15) **Human Embryonic Stem Cell (HESC) Research**

On August 9, 2001, the President announced the criteria that must be met
for Federal funds to be used for research on existing human embryonic
stem cell lines. These criteria were subsequently published by the NIH
at:
[[http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html]{.underline}](http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html).
The following eligibility criteria must be met:

1\. The derivation process (which commences with the removal of the
inner cell mass from the blastocyst) must have already been initiated
prior to August 9, 2001;

2\. Prior to August 9, 2001, the embryo from which the stem cell line
was derived no longer had the possibility of development as a human
being;

3\. The stem cells must have been derived from an embryo that was
created for reproductive purposes;

4\. The embryo was no longer needed for these purposes;

5\. Informed consent must have been obtained for the donation of the
embryo;

6\. No financial inducements were provided for the donation of the
embryo.

To facilitate research using human embryonic stem cells, the NIH has
established a Human Embryonic Stem Cell Registry (\"the NIH Registry")
that lists the human embryonic stem cells that meet the eligibility
criteria. This registry is available at:
[[http://stemcells.nih.gov/registry/]{.underline}](http://stemcells.nih.gov/registry/).

Research involving the derivation of new stem cells from human embryos
or the use of human embryonic stem cells that are not listed on the NIH
Human Embryonic Stem Cell Registry may not be conducted with Federal
funding.

If a particular human embryonic stem cell line has not been required by
the Statement of Work, an offeror proposing research involving human
embryonic stem cells must cite a human embryonic stem cell line that is
listed in the NIH Registry in its proposal.

(16) **HIV Antiretroviral Treatment Trials**

The NIH is committed to conducting HIV/AIDS research in an effort to
improve the health of people living with this disease, particularly
people in countries most affected by the epidemic. It is important that
individuals who volunteer to participate in NIH-funded HIV
antiretroviral trials be given the option to continue to receive
antiretroviral treatment following their completion of the trial. In
order to accomplish this, the contractor must work with the host
countries\' authorities and other stakeholders to identify sources
available, if any, in the country for the provision of such treatment.
It is noted that NIH cannot provide this treatment following the
completion of the research. See NIH Guide Notice, \"[Guidance for
Addressing the Provision of Antiretroviral Treatment for Trial
Participants Following Their Completion of NIH-Funded HIV Antiretroviral
Treatment Trials in Developing Countries]{.underline},\" located at:

[[http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-038.html]{.underline}](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-038.html).

The offeror\'s proposal must address a plan that describes the
following:

\- A description of available sources, if any (e.g., name of source,
location, contact person of facility/organization) for the provision of
antiretroviral treatment and care following the completion of the trial;

\- A summary of the offeror\'s interaction with the providers;

\- Documents, if any, from available sources/ providers regarding plans
for implementation;

\- A description of how this information will be conveyed to the trial
participants.

If there are no sources for antiretroviral treatment in or available to
the country in which the treatment trials will take place, the offeror
must provide:

\- A statement confirming that at the time of the offer, no sources of
antiretroviral treatment could be identified;

\- A description of how this information will be conveyed to the trial
participants;

\- A commitment to continue to explore potential sources as the trial
proceeds.

This plan or the documentation provided regarding the lack of available
sources of antiretroviral treatment will be evaluated by the Project
Officer as a part of the overall review of the proposal. While an
offeror\'s documentation of the lack of available sources for
antiretroviral treatment will not, of itself, constitute denial of a
contract award, priority for contract awards may be given to those
offerors who identify sources for the provision of antiretroviral
treatment following the completion of the trial.

(17) **(17**) **Information Technology Systems Security**

**IMPORTANT NOTE TO OFFERORS: The following information shall be
addressed in a separate section of the Technical Proposal entitled,
"Information Security."**

> The Statement of Work (SOW) requires the successful offeror to develop
> or access Federal automated information systems. Pursuant to the DHHS
> Information Security Program Policy
> (<http://www.hhs.gov/read/irmpolicy/FINALHHSInformationSecurityProgramP.doc>[)]{.underline},
> the following requirements apply:

\(1\) [Information Type]{.underline}

**\[ \]** **Administrative, Management and Support Information:**

**\[ \] Mission Based Information:**

\(2\) [Security Categories and Levels]{.underline}

Confidentiality Level: **\[ \]** Low **\[x\]** Moderate **\[ \]** High

Integrity Level: **\[ \]** Low **\[x\]** Moderate **\[ \]** High

Availability Level: **\[ \]** Low **\[x\]** Moderate **\[ \]** High

**Overall Level: \[ \] Low \[x\] Moderate \[ \] High**

\(3\) [Position Sensitivity Designations]{.underline}

Prior to award, the Government will determine the position sensitivity
designation for each contractor employee that the successful offeror
proposes to work under the contract. For proposal preparation purposes,
the following designations apply:

**\[ \] Level 6: Public Trust - High Risk (Requires Suitability
Determination with a BI).** Contractor employees assigned to a Level 6
position are subject to a Background Investigation (BI).

**\[\] Level 5: Public Trust - Moderate Risk (Requires Suitability
Determination with NACIC, MBI or LBI).** Contractor employees assigned
to a Level 5 position with no previous investigation and approval shall
undergo a National Agency Check and Inquiry Investigation plus a Credit
Check (NACIC), a Minimum Background Investigation (MBI), or a Limited
Background Investigation (LBI).

**\[x\] Level 1: Non Sensitive (Requires Suitability Determination with
an NACI).** Contractor employees assigned to a Level 1 position are
subject to a National Agency Check and Inquiry Investigation (NACI).

Upon award, the contractor will be required to submit a roster of all IT
staff working under the contract. The Government will determine the
appropriate level of suitability investigation required for each staff
member.

Contractor employees who have met investigative requirements within the
past five years may only require an updated or upgraded investigation.

\(4\) [Systems Security Plan]{.underline}

The offeror's proposal must:

\(1\) Include a plan commensurate with the size and complexity of the
requirements of the Statement of Work. The minimum areas to be addressed
include, but are not limited to administrative, technical, and physical
security as follows:

\(i\) Security Awareness Training

\(ii\) Logical Access Control

-Network (ex: firewall)

-System (ex: network OS, tcp wrappers, SSH)

-Application (ex: S-LDAP, SSL)

-Remote Access (ex: VPN)

-Monitoring and support (ex: IDS, pager, NOC)

\(iii\) Protection against data loss

-OS security (ex: patch management, configuration)

-Application security (ex: patch management)

-Database security

-Back-up and recovery

-Fault tolerance, high availability

\(iv\) Malicious Code Protection (ex: Antivirus, filtering of e-mail
attachments, etc)

\(v\) Physical Security

-Access control (ex: locks, guards)

-Power conditioning and/or UPS

-Air conditioning

-Fire protection

Include an acknowledgment of its understanding of the security
requirements.

Provide similar information for any proposed subcontractor developing or
accessing an AIS.

The SSP that the offeror must submit with its proposal shall be
finalized in coordination with the Project Officer no later than 90
calendar days after contract award.

\(e\) [Information Systems Security Training]{.underline}

DHHS policy requires contractors receive security training commensurate
with their responsibilities for performing work under the terms and
conditions of their contractual agreements.

The successful offeror will be responsible for assuring that each
contractor employee has completed the NIH Computer Security Awareness
Training
course([[http://irtsectraining.nih.gov/]{.underline}](http://irtsectraining.nih.gov/))
prior to performing any contract work, and on an annual basis
thereafter, during the period of performance of the contract. The
successful offeror shall maintain a listing of all individuals who have
completed this training and shall submit this listing to the Project
Officer.

Additional security training requirements commensurate with the position
may be required as defined in NIST Special Publication 800-16,
Information Technology Security Training Requirements
([[http://csrc.nist.gov/publications/nistpubs/800-16/800-16.pdf]{.underline}](../(http://csrc.nist.gov/publications/nistpubs/800-16/800-16.pdf)).
This document provides information about information security training
that may be useful to potential offerors.

\(f\) [Prospective Offeror Non-Disclosure Agreement]{.underline}

The Government has determined that prospective offerors **will not**
require access to Federal information described below in order to
prepare an offer.

Any individual having access to this information must possess a valid
and current suitability determination at the following level:

**\[ \] Level 6: Public Trust - High Risk**

**\[x Level 5: Public Trust - Moderate Risk**

To be considered for access to Federal information, a prospective
offeror must:

1.  Submit a written request to the Contracting Officer identified in
    the solicitation;

2.  Complete and submit the "Prospective Offeror Non-Disclosure
    Agreement" provided as an attachment in Section J of this
    solicitation; and

3.  Receive written approval from the Contracting Officer.

Prospective offerors are required to process their requests for access,
receive Government approval, and then access the Federal information
within the period of time provided in the solicitation for the
preparation of offers.

Nothing in this provision shall be construed, in any manner, by a
prospective offeror as an extension to the stated date, time, and
location in the solicitation for the submission of offers.

\(g\) [References]{.underline}

(1) DHHS Information Security Program Policy:

> [[http://www.hhs.gov/read/irmpolicy/FINALHHSInformationSecurityProgramP.doc]{.underline}](http://www.hhs.gov/read/irmpolicy/FINALHHSInformationSecurityProgramP.doc)

(2) DHHS Personnel Security/Suitability Handbook:
    [[http://www.hhs.gov/ohr/manual/pssh.pdf]{.underline}](http://www.hhs.gov/ohr/manual/pssh.pdf)

(3) NIH Systems Security Plan Template:
    [[http://irm.cit.nih.gov/security/secplantemp.doc]{.underline}](http://irm.cit.nih.gov/security/secplantemp.doc)

(4) NIH Systems Security Plan Outline:
    [[http://irm.cit.nih.gov/nihsecurity/Security_Plan_Outline.doc]{.underline}](http://irm.cit.nih.gov/nihsecurity/Security_Plan_Outline.doc)

(5) NIH Computer Security Awareness Training Course:
    [[http://irtsectraining.nih.gov/]{.underline}](http://irtsectraining.nih.gov/)

(6) NIST Special Publication 800-16, Information Technology Security
    Training Requirements:
    [[http://csrc.nist.gov/publications/nistpubs/800-16/800-16.pdf]{.underline}](http://csrc.nist.gov/publications/nistpubs/800-16/800-16.pdf)

(7) Appendix A-D:
    [[http://csrc.nist.gov/publications/nistpubs/800-16/AppendixA-D.pdf]{.underline}](http://csrc.nist.gov/publications/nistpubs/800-16/AppendixA-D.pdf)

(8) NIST SP 800-18, Guide for Developing Security Plans for Information
    Technology Systems:
    [[http://csrc.nist.gov/publications/nistpubs/index.html]{.underline}](http://csrc.nist.gov/publications/nistpubs/index.html)

(9) NIST SP 800-60, Guide for Mapping Types of Information and
    Information Systems to Security Categories, Volume I:
    [[http://csrc.nist.gov/publications/nistpubs/800-60/SP800-60V1-final.pdf]{.underline}](http://csrc.nist.gov/publications/nistpubs/800-60/SP800-60V1-final.pdf)

(10) NIST SP 800-60, Guide for Mapping Types of Information and
     Information Systems to Security Categories, Volume II:
     [[http://csrc.nist.gov/publications/nistpubs/800-60/SP800-60V2-final.pdf]{.underline}](http://csrc.nist.gov/publications/nistpubs/800-60/SP800-60V2-final.pdf)

(11) NIST SP 800-64, Security Considerations in the Information System
     Development Life
     Cycle:[[http://csrc.nist.gov/publications/nistpubs/800-64/NIST-SP800-64.pdf]{.underline}](http://csrc.nist.gov/publications/nistpubs/800-64/NIST-SP800-64.pdf)

c\. BUSINESS PROPOSAL[]{#LBUSPROPOSAL .anchor} INSTRUCTIONS

**(1)** **Basic Cost/Price Information**

The business proposal must contain sufficient information to allow the
Government to perform a basic analysis of the proposed cost or price of
the work. This information shall include the amounts of the basic
elements of the proposed cost or price. These elements will include, as
applicable, direct labor, fringe benefits, travel, materials,
subcontracts, purchased parts, shipping, indirect costs and rate, fee,
and profit.

(1) **Proposal Cover Sheet**

The following information shall be provided on the first page of your
pricing proposal:

1\. Solicitation, contract, and/or modification number;

2\. Name and address of Offeror;

3\. Name and telephone number of point of contact;

4\. Name, address, and telephone number of Contract Administration
Office, (if available);

5\. Name, address, and telephone number of Audit Office (if available);

6\. Proposed cost and/or price; profit or fee (as applicable); and
total;

7\. The following statement: By submitting this proposal, the offeror,
if selected for discussions, grants the contracting officer or an
authorized representative the right to examine, at any time before
award, any of those books, records, documents, or other records directly
pertinent to the information requested or submitted.

8\. Date of submission; and

9\. Name, title and signature of authorized representative.

This cover sheet information is for use by offerors to submit
information to the Government when cost or pricing data are not required
but information to help establish price reasonableness or cost realism
is necessary. Such information is not considered cost or pricing data,
and shall not be certified in accordance with FAR 15.406-2.

(2) **Information Other than Cost or Pricing Data**

a\) The information submitted shall consist of data to permit the
Contracting Officer and authorized representatives to determine price
reasonableness or cost realism, e.g., information to support an analysis
of material costs (when sufficient information on labor and overhead
rates is already available), or information on prices and quantities at
which the offeror has previously sold the same or similar items.

Any information submitted must support the price proposed. Include
sufficient detail or cross references to clearly establish the
relationship of the information provided to the price proposed. Support
any information provided by explanations or supporting rational as
needed to permit the Contracting Officer and authorized representative
to evaluate the documentation.

\[Unless otherwise stated in this solicitation, the information may be
submitted in the offeror\'s own format.\]

b\) The information submitted shall be at the level of detail described
below.

> 1\. **Direct Labor**
>
> Provide a time-phased (e.g., monthly, quarterly, etc.) breakdown of
> labor hours, rates, and cost by appropriate category. Key personnel
> will be separately estimated as above and identified. Give the basis
> for the estimates in each case.
>
> 2\. **Materials**
>
> Provide a consolidated price summary of individual material quantities
> included in the various tasks, orders, or contract line items being
> proposed and the basis for pricing (vendor quotes, invoice prices,
> etc.).
>
> 3\. **Subcontracted Items**
>
> Include parts, components, assemblies, and services that are to be
> produced or performed by others in accordance with offeror\'s design,
> specifications, or direction and that are applicable only to the prime
> contract. For each subcontract over \$550,000, the support should
> provide a listing by source, item, quantity, price, type of
> subcontract, degree of competition, and basis for establishing source
> and reasonableness of price, as well as the results of review and
> evaluation of subcontract proposals when required by FAR 15.404-3.
>
> 4\. **Raw Materials**
>
> Consists of material in a form or state that requires further
> processing. Provide priced quantities of items required for the
> proposal.
>
> 5\. **Purchased Parts**
>
> Includes material items not covered above. Provide priced quantities
> of items required for the proposal.

6\. **Fringe Benefits**

> Show fringe benefits as a separate line item. Include the rate(s)
> and/or method of calculating fringe benefits. Provide a copy of your
> fringe benefit rate or institutional guidelines.
>
> 7\. **Indirect Costs**
>
> Indicate how offeror has computed and applied offeror\'s indirect
> costs, including cost breakdowns, and provide a basis for evaluating
> the reasonableness of proposed rates. Indicate the rates used and
> provide an appropriate explanation. Where a rate agreement exists,
> provide a copy.
>
> 8\. **Special Equipment**
>
> If direct charge, list any equipment proposed including description,
> price, quantity, total price, purchase or lease, and the basis for
> pricing.
>
> 9\. **Travel**
>
> Provide the cost of travel including destination, duration, purpose,
> per diem, transportation, and the basis for pricing.
>
> 10\. **Other Costs**
>
> List all other costs not otherwise included in the categories
> described above (e.g., computer services, consultant services) and
> provide basis for pricing.

(3) **Requirements for Cost or Pricing Data or Information Other than
    Cost and Pricing Data** \[FAR Clause 52.215-20 (October 1997)\]

\(a\) Exceptions from cost or pricing data.

\(1\) In lieu of submitting cost or pricing data, offerors may submit a
written request for exception by submitting the information described in
the following subparagraphs. The Contracting Officer may require
additional supporting information, but only to the extent necessary to
determine whether an exception should be granted, and whether the price
is fair and reasonable.

\(i\) Identification of the law or regulation establishing the price
offered. If the price is controlled under law by periodic rulings,
reviews, or similar actions of a governmental body, attach a copy of the
controlling document, unless it was previously submitted to the
contracting office.

\(ii\) Commercial item exception. For a commercial item exception, the
offeror shall submit, at a minimum, information on prices at which the
same item or similar items have previously been sold in the commercial
market that is adequate for evaluating the reasonableness of the price
for this acquisition. Such information may include\--

\(A\) For catalog items, a copy of or identification of the catalog and
its date, or the appropriate pages for the offered items, or a statement
that the catalog is on file in the buying office to which the proposal
is being submitted. Provide a copy or describe current discount policies
and price lists (published or unpublished), e.g., wholesale, original
equipment manufacturer, or reseller. Also explain the basis of each
offered price and its relationship to the established catalog price,
including how the proposed price relates to the price of recent sales in
quantities similar to the proposed quantities;

\(B\) For market-priced items, the source and date or period of the
market quotation or other basis for market price, the base amount, and
applicable discounts. In addition, describe the nature of the market;

\(C\) For items included on an active Federal Supply Service Multiple
Award Schedule contract, proof that an exception has been granted for
the schedule item.

\(2\) The offeror grants the Contracting Officer or an authorized
representative the right to examine, at any time before award, books,
records, documents, or other directly pertinent records to verify any
request for an exception under this provision, and the reasonableness of
price. For items priced using catalog or market prices, or law or
regulation, access does not extend to cost or profit information or
other data relevant solely to the offeror\'s determination of the prices
to be offered in the catalog or marketplace.

\(b\) Requirements for cost or pricing data. If the offeror is not
granted an exception from the requirement to submit cost or pricing
data, the following applies:

\(1\) The offeror shall prepare and submit cost or pricing data and
supporting attachments in accordance with Table 15-2 of FAR 15.408.

\(2\) As soon as practicable after agreement on price, but before
contract award (except for unpriced actions such as letter contracts),
the offeror shall submit a Certificate of Current Cost or Pricing Data,
as prescribed by FAR 15.406-2.

(End of provision)

(4) **Qualifications of the Offeror**

You are requested to submit a summary of your \"General Experience,
Organizational Experience Related to this RFP, Performance History and
Pertinent Contracts.\"

> a\) **General Experience**
>
> *General experience* is defined as general background, experience and
> qualifications of the offeror. A discussion of proposed facilities
> which can be devoted to the project may be appropriate.
>
> b\) **Organizational Experience Related to the RFP**
>
> *Organizational experience* is defined as the accomplishment of work,
> either past or on-going, which is comparable or related to the effort
> required by this RFP. This includes overall offeror or corporate
> experience, **but not** the experience and/or past performance of
> individuals who are proposed as personnel involved with the Statement
> of Work in this RFP.
>
> c\) **Performance History**
>
> *Performance history* is defined as meeting contract objectives within
> [delivery]{.underline} and [cost]{.underline} [schedules]{.underline}
> on efforts, either past or on-going, which is comparable or related to
> the effort required by this RFP.
>
> d\) **Pertinent Contracts**
>
> *Pertinent contracts* is defined as a listing of each related contract
> completed within the last three years or currently in process. The
> listing should include: 1) the contract number; 2) contracting agency;
> 3) contract dollar value; 4) dates contract began and ended (or ends);
> 5) description of contract work; 6) explanation of relevance of work
> to this RFP; 7) actual delivery and cost performance versus delivery
> and cost agreed to in the contract(s). For award fee contracts,
> separately state in dollars the base fee and award fee available and
> the award fee actually received. The same type of organizational
> experience and past performance data should be submitted.
>
> e\) **Pertinent Grants**
>
> List grants supported by the Government that involved similar or
> related work to that called for in this RFP. Include the grant number,
> involved agency, names of the grant specialist and the Science
> Administrator, identification of the work, and when performed.
>
> You are cautioned that omission or an inadequate or inaccurate
> response to this very important RFP requirement could have a negative
> effect on the overall selection process. Experience and past
> performance are factors which are relevant to the ability of the
> offerors to perform and are considered in the source selection
> process.

(5) **Other Administrative Data**

a\) **Property**

> \(1\) It is DHHS policy that Contractors will provide all equipment
> and facilities necessary for performance of contracts. Exception may
> be granted to furnish Government-owned property, or to authorize
> purchase with contract funds, only when approved by the Contracting
> Officer. If the offeror is proposing that the Government provide any
> equipment, other than that specified under Government Furnished
> Property in the RFP, the proposal must include comprehensive
> justification which includes:

\(a\) An explanation that the item is for a special use essential to the
direct performance of the contract and the item will be used exclusively
for the purpose. Office equipment such as desks, office machines, etc.,
will not be provided under a contract except under very exceptional
circumstances.

\(b\) No practical or economical alternative exists (e.g., rental,
capital investment) that can be used to perform the work.

> \(2\) The offeror shall identify Government-owned property in its
> possession and/or Contractor titled property acquired from Federal
> funds, which it proposes to use in the performance of the prospective
> contract.
>
> \(3\) The management and control of any Government property shall be
> in accordance with DHHS Publication (OS) 686 entitled, \"Contractor\'s
> Guide for Control of Government Property (1990),\" a copy of which
> will be provided upon request.

c\) **Submission of Electronic Funds Transfer Information with Offer,
FAR Clause 52.232-38**, (May 1999)

The offeror shall provide, with its offer, the following information
that is required to make payment by electronic funds transfer (EFT)
under any contract that results from this solicitation. This submission
satisfies the requirement to provide EFT information under paragraphs
(b)(1) and (j) of the clause at 52.232-34, Payment by Electronic Funds
Transfer\--Other than Central Contractor Registration.

\(1\) The solicitation number (or other procurement identification
number).

\(2\) The offeror\'s name and remittance address, as stated in the
offer.

\(3\) The signature (manual or electronic, as appropriate), title, and
telephone number of the offeror\'s official authorized to provide this
information.

\(4\) The name, address, and 9-digit Routing Transit Number of the
offeror\'s financial agent.

\(5\) The offeror\'s account number and the type of account (checking,
savings, or lockbox).

\(6\) If applicable, the Fedwire Transfer System telegraphic
abbreviation of the offeror\'s financial agent.

\(7\) If applicable, the offeror shall also provide the name, address,
telegraphic abbreviation, and 9-digit Routing Transit Number of the
correspondent financial institution receiving the wire transfer payment
if the offeror\'s financial agent is not directly on-line to the Fedwire
and, therefore, not the receiver of the wire transfer payment.

d\) **Financial Capacity**

> The offeror shall indicate if it has the necessary financial capacity,
> working capital, and other resources to perform the contract without
> assistance from any outside source. If not, indicate the amount
> required and the anticipated source.

e\) **Incremental Funding**

> An incrementally funded cost-reimbursement contract is a contract in
> which the total work effort is to be performed over a multiple year
> period and funds are allotted, as they become available, to cover
> discernible phases or increments of performance. The incremental
> funding technique allows for contracts to be awarded for periods in
> excess of one year even though the total estimated amount of funds
> expected to be obligated for the contract are not available at the
> time of the contract award. If this requirement is specified elsewhere
> in this RFP, the offeror shall submit a cost proposal for each year.
> In addition, the following provisions are applicable:
>
> **HHSAR 352.232-75, Incremental Funding (January 2001)**

\(a\) It is the Government\'s intention to negotiate and award a
contract using the incremental funding concepts described in the clause
entitled Limitation of Funds. Under the clause, which will be included
in the resultant contract, initial funds will be obligated under the
contract to cover the first year of performance. Additional funds are
intended to be allotted to the contract by contract modification, up to
and including the full estimated cost of the contract, to accomplish the
entire project. While it is the Government\'s intention to progressively
fund this contract over the entire period of performance up to and
including the full estimated cost, the Government will not be obligated
to reimburse the Contractor for costs incurred in excess of the periodic
allotments, nor will the Contractor be obligated to perform in excess of
the amount allotted.

\(b\) The Limitation of Funds clause to be included in the resultant
contract shall supersede the Limitation of Cost clause found in the
General Provisions.

(End of provision)

f\) **Facilities Capital Cost of Money**, FAR 52.215-16, (June 2003)

> (This is applicable if you are a commercial organization.)
>
> \(a\) Facilities capital cost of money will be an allowable cost under
> the contemplated contract, if the criteria for allowability in FAR
> 31.205-10(b) are met. One of the allowability criteria requires the
> prospective Contractor to propose facilities capital cost of money in
> its offer.

\(b\) If the prospective Contractor does not propose this cost, the
resulting contract will include the clause Waiver of Facilities Capital
Cost of Money.

(End of Provision)

If the offeror elects to claim this cost, the offeror shall specifically
identify or propose it in the cost proposal for the contract by checking
the appropriate box below.

> **\[ \]** The prospective Contractor has specifically identified or
> proposed facilities capital cost of money in its cost proposal and
> elects to claim this cost as an allowable cost under the contract.
> Submit Form CASB-CMF (see FAR 31.205-10).
>
> **\[ \]** The prospective Contractor has not specifically identified
> or proposed facilities capital cost of money in its proposal and
> elects not to claim it as an allowable cost under the contract.

(6) **Subcontractors**

> If subcontractors are proposed, please include a commitment letter
> from the subcontractor detailing:
>
> a\) Willingness to perform as a subcontractor for specific duties
> (list duties).
>
> b\) What priority the work will be given and how it will relate to
> other work.
>
> c\) The amount of time and facilities available to this project.
>
> d\) Information on their cognizant field audit offices.
>
> e\) How rights to publications and patents are to be handled.

f\) A complete cost proposal in the same format as the offeror\'s cost
proposal.

Note: Organizations that plan to enter into a subcontract with an
educational concern under a contract awarded under this RFP should refer
to the following Web Site for a listing of clauses that are required to
be incorporated in Research & Development (R&D) subcontracts with
educational institutions:

[[http://ocm.od.nih.gov/contracts/rfps/FDP/FDPclausecover.htm]{.underline}](http://ocm.od.nih.gov/contracts/rfps/FDP/FDPclausecover.htm)

(7) **Proposer\'s Annual Financial Report**

All offerors included in the competitive range will be required to
submit a copy of the organization\'s most recent annual financial
report.

(8) **Representations and Certifications**

> One copy of the Representations and Certifications attached as Section
> K shall be completed and be signed by an official authorized to bind
> your organization. Additionally, a completed copy of the
> Representations and Certifications shall be submitted from any
> proposed subcontractor.

(9) **Travel Costs/Travel Policy**

a\) **Travel Costs - Commercial**

> Costs for lodging, meals, and incidental expenses incurred by
> Contractor personnel shall be considered to be reasonable and
> allowable to the extent they do not exceed on a daily basis the per
> diem rates set forth in the Federal Travel Regulations, General
> Services Administration (GSA). Therefore, if travel costs are
> applicable and proposed by offerors, please be advised that they shall
> be calculated using the per diem rate schedule as established by GSA.
> Reimbursement of travel costs under any contract awarded from this RFP
> shall be in accordance with FAR 31.205-46.

b\) **Travel Policy**

> One copy of the offeror\'s (and any proposed subcontractor\'s) written
> travel policy shall be included in the business proposal (original
> only). If an offeror (or any proposed subcontractor) does not have a
> written travel policy, the offeror shall so state.

**(12)** **Certification of Visas for Non-U.S. Citizens**

Proposed personnel under research projects are not required to be
citizens of the United States. However, if non-U.S. citizens are
proposed under a contract to be performed in the United States and its
outlying areas, then the offeror must indicate in the proposal that
these individuals have the required visas.

**(13) Total Compensation Plan - Instructions**

a\) Total compensation (salary and fringe benefits) of professional
employees under service contracts may, in some cases, be lowered by
recompetition of these contracts. Lowering of compensation can be
detrimental in obtaining the necessary quality of professional services
needed for adequate performance of service contracts. It is, therefore,
in the best interest of the Government that professional employees, as
defined in 29 CFR Part 541, be properly compensated in these contracts.
All offerors as a part of their business proposal will submit a \"Total
Compensation Plan\" (salaries and fringe benefits) for these
professional employees for evaluation purposes.

> b\) The Government will evaluate the Total Compensation Plan to ensure
> that this compensation reflects a sound management approach and an
> understanding of the requirements to be performed. It will include an
> assessment of the offeror\'s ability to provide uninterrupted work of
> high quality. The total compensation proposed will be evaluated in
> terms of enhancing recruitment and retention of personnel and its
> realism and consistency with a total plan for compensation (both
> salaries and fringe benefits).
>
> c\) Evaluation for award, therefore, will include an assessment of the
> Total Compensation Plan submitted by each offeror.
>
> **Total Compensation Plan - Evaluation**
>
> a\) **Total Compensation Plan (Professional Employees)**
>
> In establishing compensation levels for professional employees, the
> total compensation (both salaries and fringe benefits) proposed shall
> reflect a clear understanding of the requirements of the work to be
> accomplished and the suitability of the proposed compensation
> structure to obtain and retain qualified personnel to meet mission
> objectives. The salary rates or ranges must recognize the distinct
> differences in professional skills and the complexity of varied
> disciplines as well as job difficulty. Proposals offering total
> compensation levels less than currently being paid by the predecessor
> Contractor for the same work will be evaluated, in addition to the
> above, on the basis of maintaining program continuity, uninterrupted
> work of high quality, and availability of required competent
> professional employees. Offerors are cautioned that instances of
> lowered compensation for essentially the same professional work may be
> considered a lack of sound management judgment in addition to
> indicating a lack of understanding of the requirement.
>
> b\) **Cost (Professional Compensation)**
>
> Proposals which are unrealistically low or do not reflect a reasonable
> relationship of compensation to the professional job categories so as
> to impair the Contractor\'s ability to recruit and retain competent
> professional employees, may be viewed as reflecting a failure to
> comprehend the complexity of the contract requirements. The Government
> is concerned with the quality and stability of the work force to be
> employed on this contract. The compensation data required will be used
> in evaluation of the offeror\'s understanding of the contract
> requirements.
>
> c\) **Other (Labor Relations)**
>
> An assessment of the potential for adverse effect upon performance and
> maintenance of the required number of professional employees with
> requisite skills resulting from an unrealistically low compensation
> structure will also be made.

d\) **Federal Acquisition Regulation Clauses incorporated by Reference**

> FAR Clause 52.222-46, Evaluation of Compensation for Professional
> Employees (FEBRUARY 1993).

[]{#__RefHeading___Toc124312182 .anchor}SECTION M - EVALUATION FACTORS
FOR AWARD

1\. []{#mgeneral .anchor}**GENERAL**

Selection of an offeror for contract award will be based on an
evaluation of proposals against four factors. The factors in order of
importance are: technical, cost, past performance and Small
Disadvantaged Business (SDB) participation. Although technical factors
are of paramount consideration in the award of the contract, past
performance, cost/price and SDB participation are also important to the
overall contract award decision. All evaluation factors other than cost
or price, when combined, are significantly more important than cost or
price. In any event, the Government reserves the right to make an
award(s) to that Offeror whose proposal provides the best overall value
to the Government.

The evaluation will be based on the demonstrated capabilities of the
prospective Contractors in relation to the needs of the project as set
forth in the RFP. The merits of each proposal will be evaluated
carefully. Each proposal must document the feasibility of successful
implementation of the requirements of the RFP. Offerors must submit
information sufficient to evaluate their proposals based on the detailed
criteria listed below.

2\. **HUMAN SUBJECT**[]{#mhumansubjects .anchor} **EVALUATION**

> This research project involves human subjects. NIH Policy requires:

\(a\) **Protection of Human Subjects from Research Risks**

The offeror's proposal must address the involvement of human subjects
and protections from research risk relating to their participation in
the proposed research plan, or provide sufficient information on the
research subjects to allow a determination by NCI that a designated
exemption is appropriate.

If you claim that this research should be considered exempt from
coverage by the Federal Regulations at 45 CFR 46, the proposal should
address why you believe it is exempt, and under which exemption it
applies.

> The reviewers will evaluate the proposal with regard to four issues:
> Risks to Human Subjects, Adequacy of Protection Against Risks,
> Potential Benefits of the Proposed Research to the Subjects and
> Others, and Importance of the Knowledge to be Gained. See Section L
> for a complete discussion of what is required to be addressed for each
> of these issues. Based on the response to this criterion, this section
> of the proposal may be rated "unacceptable" (i.e., concerns are
> identified as to the protections described against risk to human
> subjects or no discussion is found regarding protections against risk
> to human subjects) or "acceptable." If the reviewers find that this
> portion of the proposal is \"unacceptable\" they will provide a
> narrative supporting their finding.

If the Government includes your proposal in the competitive range (for
competitive proposals), or if the Government holds discussions with the
selected source (for sole source acquisitions), you will be afforded the
opportunity to address the concerns raised by the reviewers. You will be
able to further discuss and/or clarify your position until submission of
your Final Proposal Revision (FPR). Once discussions are closed with the
submission of your FPR, if your proposed plan for the protection of
human subjects from research risks is still found to be unacceptable,
then your proposal may not be considered further for award.

\(b\) **Data and Safety Monitoring**

The offeror's proposal must include a general description of the Data
and Safety Monitoring Plan for all clinical trials. The principles of
data and safety monitoring require that all biomedical and behavioral
clinical trails be monitored to ensure the safe and effective conduct of
human subjects research, and to recommend conclusion of the trial when
significant benefits or risks are identified or if it is unlikely that
the trial can be concluded successfully. Risks associated with
participation in research must be minimized to the extent practical and
the method and degree of monitoring should be commensurate with risk.
Additionally, all plans must include procedures for adverse event
reporting. Finally, generally, for Phase III clinical trials, the
establishment of a Data and Safety Monitoring Board (DSMB) is required,
whereas for Phase I and II clinical trials, the establishment of a DSMB
is optional. The reviewers will rely on the Statement of Work and
Section L in the solicitation, as well as any further technical
evaluation criteria in this Section M, as applicable, for the
solicitation\'s specific requirements for data and safety monitoring.

As a part of the evaluation for proposals, the reviewers will consider
the acceptability of the proposed data and safety monitoring plan with
respect to the potential risks to human participants, complexity of
study design, and methods for data analysis. Based on the evaluation of
the response to this criterion, this section of the proposal may be
rated "unacceptable" (i.e., concerns are identified as to the adequacy
of the monitoring plan or no discussion can be found regarding the
proposed monitoring plans) or "acceptable." If the reviewers find that
this portion of the proposal is \"unacceptable\" they will provide a
narrative supporting their finding.

If the Government includes your proposal in the competitive range (for
competitive proposals), or if the Government holds discussions with the
selected source (for sole source acquisitions), you will be afforded the
opportunity to address the concerns raised by the reviewers. You will be
able to further discuss and/or clarify your position until submission of
your Final Proposal Revision (FPR). Once discussions are closed with the
submission of your FPR, if your proposed plan for data and safety
monitoring is still found to be unacceptable, then your proposal may not
be considered further for award.

\(c\) **Women and Minorities**

Women and members of minority groups and their subpopulations must be
included in the study population of research involving human subjects,
unless a clear and compelling rationale and justification are provided
indicating that inclusion is inappropriate with respect to the health of
the subjects or the purpose of the research. In addition, for
NIH-Defined Phase III clinical trials, all proposals and/or protocols
must provide a description of plans to conduct analyses, as appropriate,
to detect significant differences in intervention effect (see NIH Guide
[[http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm]{.underline}](http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm),
Definitions - Significant Difference) by sex/gender, racial/ethnic
groups, and relevant subpopulations, if applicable, unless the
Government has specified that this solicitation involves a sex/gender
specific study or a single or limited number of minority population
groups. The proposal also must include one of the following plans:

\- Plans to conduct valid analysis to detect significant differences in
intervention effect among sex/gender and/or racial/ethnic subgroups when
prior studies strongly support these significant differences among
subgroups, OR

\- Plans to include and analyze sex/gender and/or racial/ethnic
subgroups when prior studies strongly support no significant differences
in intervention effect between subgroups (representation of sex/gender
and/or racial/ethnic groups as subject selection criterion is not
required; however, inclusion and analyses are encouraged), OR

\- Plans to conduct valid analyses of the intervention effect in
sex/gender and/or racial/ethnic subgroups (without requiring high
statistical power for each subgroup) when the prior studies neither
support nor negate significant differences in intervention effect
between subgroups.

Also, the proposal must address the proposed outreach programs for
recruiting women and minorities as participants.

> Reviewers will consider the areas covered here and in Section L of the
> solicitation in narrative form in their evaluation. Some of the issues
> they will evaluate include:

\- whether the plan proposed includes minorities and both genders in
adequate representation

\- how the offeror addresses the inclusion of women and members of
minority groups and their subpopulations in the development of a
proposal that is appropriate to the scientific objectives of the
solicitation

\- the description of the proposed study populations in terms of
sex/gender and racial/ethnic groups and the rationale for selection of
such subjects

\- if exclusion is proposed, that the rationale is appropriate with
respect to the health of the subjects and/or to the purpose of the
research.

\- In addition, for gender exclusion, the reviewers will examine the
rationale to determine if it is because:

\- the purpose of the research constrains the offeror's selection of
study participants by gender (e.g., uniquely valuable stored specimens
or existing datasets are single gender; very small numbers of subjects
are involved; or

\- overriding factors dictate selection of subjects); or

\- gender representation of specimens or existing datasets cannot be
accurately determined, [and]{.underline} this does not compromise the
scientific objectives of the research.

\- For minority group exclusion, the reviewers will examine the
rationale to determine if those minority groups are excluded because:

\- inclusion of those groups would be inappropriate with respect to
their health;or

\- inclusion of those groups would be inappropriate with respect to the
purpose of the research.

\- For NIH-defined Phase III clinical trials, reviewers will also
consider whether there is an adequate description of plans to conduct
analyses to detect significant differences of clinical or public health
importance in intervention effect(s) by sex/gender and/or racial ethnic
subgroups when the intervention effect(s) is expected in the primary
analyses, or if there is an adequate description of plans to conduct
valid analyses of the intervention effect in subgroups when the
intervention effect(s) is [not]{.underline} expected in the primary
analyses.

> If you determine that inclusion of women and minority populations is
> not feasible, you must submit a detailed rationale and justification
> for exclusion of one or both groups from the study population with the
> technical proposal. The Government will review the rationale to
> determine if it is appropriate with respect to the health of the
> subjects and/or the purpose of the research
>
> Based on the evaluation of the response to this criterion, this
> section of the proposal may be rated "unacceptable" (i.e., no
> discussion can be found regarding the proposed gender/minority
> inclusion plans, or concerns are identified as to the gender or
> minority representation, or the proposal does not adequately address
> limited representation of one gender or minority; or the plan is not
> in accordance with NIH policy guidelines) or "acceptable." See Section
> L of the solicitation for the requirements of women/minorities
> inclusion. If the reviewers find that this portion of the proposal is
> \"unacceptable\" they will provide a narrative supporting their
> finding.

If the Government includes your proposal in the competitive range (for
competitive proposals), or if the Government holds discussions with the
selected source (for sole source acquisitions), you will be afforded the
opportunity to address the concerns raised by the reviewers. You will be
able to further discuss and/or clarify your position until submission of
your Final Proposal Revision (FPR). Once discussions are closed with the
submission of your FPR, if your proposed plan for the
inclusion/exclusion of women and minorities is still found to be
unacceptable, then your proposal may not be considered further for
award.

\(d\) **Children**

Children (i.e. individuals under the age of 21) must be included in all
human subject research unless there are clear and compelling reasons not
to include them.

> Your proposal must include a description of plans for including
> children. If you plan to exclude children from the required research,
> your proposal must present an acceptable justification for the
> exclusion. If you determine that exclusion of a specific age range of
> child is appropriate, your proposal must also address the rationale
> for such exclusion. Also, the plan must include a description of the
> expertise of the investigative team for dealing with children at the
> ages included, of the appropriateness of the available facilities to
> accommodate the children, and the inclusion of a sufficient number of
> children to contribute to a meaningful analysis relative to the
> purpose/objective of the solicitation. Also, see Section L of the
> solicitation for further specific requirements on inclusion of
> children.
>
> Based on the reviewers' evaluation of the offeror's response, this
> section of the proposal may be rated "unacceptable" (i.e., no
> discussion can be found regarding the proposed inclusion plans for
> children; or concerns are identified as to the offeror's response
> regarding the inclusion of children; or the plan is not in accordance
> wit h NIH policy guidelines) or "acceptable." If the reviewers find
> that this portion of the proposal is \"unacceptable\" they will
> provide a narrative supporting their finding.

If the Government includes your proposal in the competitive range (for
competitive proposals), or if the Government holds discussions with the
selected source (for sole source acquisitions), you will be afforded the
opportunity to address the concerns raised by the reviewers. You will be
able to further discuss and/or clarify your position until submission of
your Final Proposal Revision (FPR). Once discussions are closed with the
submission of your FPR, if your proposed plan for the inclusion of
children is still found to be unacceptable, then your proposal may not
be considered further for award.

If the information provided in your proposal about the inclusion of
children is rated "unacceptable" and the Government includes your
proposal in the competitive range (for competitive proposals), or if the
Government holds discussions with the selected source (for sole source
acquisitions), you will be afforded the opportunity to further discuss,
clarify or modify your plan during discussions and in your Final
Proposal Revision (FPR). If your plan for inclusion of children is still
considered "unacceptable" by the Government after discussions, your
proposal may not be considered further for award.

e\. **HIV Antiviral Treatment Trials**

The offeror\'s proposal must address a plan to have host countries
authorities and/or other stakeholders identify sources available, if
any, to provide antiretroviral treatment to HIV-affected populations
that have participated in the contract-funded HIV antiretroviral
treatment trial, OR describe why the offeror believes that there are no
such sources available. The information provided must be in accordance
with Section L.

The Project Officer will evaluate the documentation provided. While an
offeror\'s documentation of the lack of available sources for
antiretroviral treatment will not, of itself, constitute denial of a
contract award, priority for contract awards may be given to those
offerors who identify sources for the provision of antiretroviral
treatment following the completion of the trial.

3\. **EVALUATION OF**[]{#moptions .anchor} **OPTIONS**

> It is anticipated that any contract(s) awarded from this solicitation
> will contain option provisions and periods.
>
> Offerors must propose the options described in the Statement of Work.
> Offerors submitting a proposal under this solicitation must prepare a
> Technical Proposal and Business Proposal for the entire Statement of
> Work including options.   Proposals for the basic effort alone, or the
> options alone will not be accepted for review or considered for
> award.  In accordance with FAR Clause 52.217-5, Evaluation of Options.
> (July 1990), the Government will evaluate offers for award purposes by
> adding the total price for all options to the total price for the
> basic requirement, except when it is determined in accordance with FAR
> 17.206(b) not to be in the Government\'s best interests. Evaluation of
> options will not obligate the Government to exercise the option(s).

4\. **EVALUATION OF DATA** []{#mdatasharing .anchor}**SHARING PLAN**

The offeror\'s plan for the sharing of final research data shall be
assessed for appropriateness and adequacy.

> If your proposal does not include a plan or if the plan in your
> proposal is considered "unacceptable," and the Government includes
> your proposal in the competitive range (for competitive proposals), or
> if the Government holds discussions with the selected source (for sole
> source acquisitions), you will be afforded the opportunity to further
> discuss, clarify or modify your data sharing plan during discussions
> and in your Final Proposal Revision (FPR). If your data sharing plan
> is still considered "unacceptable" by the Government after
> discussions, your proposal may not be considered further for award.

5\. []{#evalmodelsharing .anchor}**EVALUATION OF PLAN FOR SHARING MODEL
ORGANISMS FOR BIOMEDICAL RESEARCH**

> The offeror's proposal must address the plans for sharing model
> organisms, OR state appropriate reasons why such sharing is restricted
> or not possible. Offerors must also address as part of the sharing
> plan if, or how, they will exercise their intellectual property rights
> while making model organisms and research resources available to the
> broader scientific community. The discussion areas regarding
> intellectual property outlined in Section L should be addressed.

If your proposal does not include a plan, appropriate reasons for
restricting sharing, or, if the plan in your proposal is considered
"unacceptable," and the Government includes your proposal in the
competitive range (for competitive proposals), or if the Government
holds discussions with the selected source (for sole source
acquisitions), you will be afforded the opportunity to further discuss,
clarify or modify your plan for sharing model organisms during
discussions and in your Final Proposal Revision (FPR). If your plan for
sharing model organisms is still considered "unacceptable," or your
justification for restricting sharing is still considered inappropriate
by the Government after discussions, your proposal may not be considered
further for award.

6\. **TECHNICAL** []{#mtechevalcriteria .anchor}**EVALUATION CRITERIA**

> The evaluation criteria are used by the technical evaluation committee
> when reviewing the technical proposals. The criteria below are listed
> in the order of relative importance with weights assigned for
> evaluation purposes.

**[CRITERIA]{.underline}** **[WEIGHT]{.underline}**

> **CRITERION 1: ORGANIZATIONAL STRUCTURE AND OVERALL**
>
> **MANAGEMENT AND COORDINATION 30**
>
> The strength, appropriateness, adequacy and feasibility of proposed
> plans in the following areas:

1.  [Plan for Scientific Management and Coordination]{.underline},
    including: (i) priority setting; (ii) development, review and
    approval of concepts for proposed studies, including ethical
    issues; (iii) monitoring and evaluating progress and
    performance; (iv) resource allocation; (v) composition and proposed
    policies of the Executive Committee; (vi) composition and proposed
    policies and procedures of the Protocol Review Committee with
    respect to the solicitation, technical evaluation and development of
    recommendations on proposed clinical trials, mechanistic studies,
    tolerance assay studies and nonclinical research and product
    development; and (vii) the composition and roles of other
    committees/organizational entities proposed.

2.  [Protocol Development and Implementation]{.underline},
    including: (i) proposed policies and procedures for full protocol
    development; (ii) procedures and criteria to be used to assess and
    select non-Network CTUs to participate in clinical trials; and (iii)
    proposed policies and procedures to ensure timely and accurate
    completion of clinical trials and reporting on trial results.

3.  [Laboratories]{.underline}, including: (i) plan for the
    establishment and management of Network Laboratories, including
    proposed membership, criteria for selection and capabilities; (ii)
    policies, procedures and criteria to be used to assess and select
    non-Network laboratories; and (iii) proposed distribution of
    responsibilities, lines of reporting authority, and communications.

> **CRITERION 2: TECHNICAL APPROACH AND PLANS** **25**
>
> The soundness, appropriateness, adequacy and feasibility of:

1.  [Strategic Plan and Research Agenda, including]{.underline}: (i) the
    proposed approaches to the design of clinical trials and mechanistic
    studies; (ii) immediate and long-range goals, and timelines and
    milestones for meeting major goals; (iii) proposed approaches to
    address new scientific or programmatic developments and objectives
    through periodic review and revision of the Plan; (iv) approaches to
    identify and capitalize on opportunities for industry
    partnerships; (v) proposed clinical trials and mechanistic studies
    and the rationale for their prioritization; and (vi) suitability of
    the plan to establish a national and international consortium of
    experts to design and conduct clinical trials and mechanistic
    studies for tolerance induction in the areas of transplantation,
    autoimmune and asthma and allergic diseases.

2.  [Nonclinical Research and Product Development,
    including]{.underline} the proposed approach and methods to be used
    to: (i) conduct feasibility assessments of clinical trials proposals
    with respect to the need for additional nonclinical studies required
    prior to study initiation and the availability and quality of the
    candidate drug; (ii) conduct nonclinical studies (including, proof
    of principle, toxicology, pharmacodynamics and pharmacokinetics
    studies, and absorption, distribution, metabolism and excretion
    studies); (iii) perform cGMP manufacture of candidate drugs; (iv)
    develop and use qualified assays to measure study product levels
    and/or immunogenicity; (v) evaluate study data; and (vi) audit and
    oversee test facilities, personnel and equipment for compliance with
    cGLP and cGMP requirements.

3.  [Clinical Trial Units (CTUs)]{.underline}:

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a.  CTUs, including: the number of Network and non-Network CTUs proposed
    in relation to the feasibility of implementing the Strategic Plan
    and Research Agenda; (ii) demonstrated availability of a patient
    pool adequate to ensure the timely screening and enrollment of study
    participants; (iii) demonstrated experience of the
    organizations/institutions proposed with respect to: the conduct and
    management of clinical trials, including patient screening,
    recruitment, enrollment and retention; informed consent; assessment
    and reporting of adverse events; collection and laboratory analysis
    of patient specimens; management of study products; collection,
    quality control and management of study data; and creation,
    maintenance and storage of research records; and (iv) clinical and
    pharmacy facilities as well as facilities and equipment for the
    collection, testing, storage and shipping of protocol-related
    patient samples in accordance with protocol specifications and
    requirements.

    1.  [Assay and Mechanistic Studies and Laboratories]{.underline}:
        Proposed approaches, methods and plans to: (i) evaluate,
        prioritize and select assays; (ii) design and conduct
        mechanistic studies and evaluations of potential
        immune/surrogate markers; (iii) process, ship, track, store and
        distribute samples and sample collection kits; (iv) establish
        performance standards and metrics for assays and
        laboratories; (v) develop standard operating procedures for
        quality assurance and quality control of assays; and (vi) assess
        and implement new technologies and transitions from existing to
        new technologies. Adequacy of the number of proposed
        Laboratories in relation to the feasibility of implementing the
        Strategic Plan and Research Agenda.

    2.  [Bioinformatics, Data Collection and Validation]{.underline}:
        Proposed approaches, methods and plans to: (i) establish a data
        management system for the collection, storage, archiving and
        exchange of clinical and mechanistic study data from multiple
        sources; (ii) develop software for the capture, analysis, query
        and storage of scientific data; (iii) build a scalable network
        and computer infrastructure; (iv) establish and implement a
        sample tracking and inventory system; (v) create an integrated
        electronic data repository; (vi) disseminate software
        applications; (vii) develop and disseminate protocols and
        standard operating procedures; (viii) develop and implement a
        long-range plan for the long-term maintenance and survival of
        scientific data and the data system and for monitoring security
        and system performance; (ix) ensure the interoperability of data
        systems and/or portability of data; (x) design and implement a
        reliable system of quality control; and (xi) provide scientific
        leadership in the design and selection studies and conduct data
        analyses for mechanistic and combined clinical and mechanistic
        data.

    3.  [Collaborations with Other Clinical Research Programs and
        Organizations]{.underline}: Proposed plans for the development
        of future collaborations, including the anticipated benefit of
        such collaborations to furthering progress in immune tolerance
        research.

    4.  [Initial and final transition plans]{.underline}: Ability to
        develop and implement initial and transition plans to execute
        the orderly transfer of this project to a successor contractor.

> **CRITERION 3: QUALIFICATIONS OF PROPOSED PERSONNEL 20**
>
> Appropriateness and relevance of the documented training, experience,
> expertise and availability of proposed scientific, technical staff and
> administrative in relation to their specific duties and
> responsibilities, as follows:

1.  [Qualifications of the proposed Principal Investigator]{.underline}
    to lead and direct the activities to be carried out under this
    contract either directly or indirectly through subcontracts. This
    includes: scientific and technical expertise in scientific
    disciplines relevant to tolerance induction; the evaluation of
    tolerance induction therapies in humans for transplantation,
    autoimmune disorders, and asthma and allergic diseases; the
    development and conduct of immune/surrogate markers and studies of
    underlying mechanisms; the solicitation and evaluation of the
    technical merit of subcontract proposals; and the capacity to
    monitor progress, assess performance, identify performance problems
    and implement corrective actions.

2.  [Qualifications of all scientific and technical staff]{.underline},
    including subcontractors, with respect to conducting the range of
    studies and services required, including a proven track record in
    the design and conduct of clinical trials, mechanistic studies,
    development of immune/surrogate markers, nonclinical research and
    product development, and bioinformatics, data management and
    analysis activities carried out under subcontract.

3.  [Adequacy, thoroughness and feasibility of the detailed technical
    approaches and plans]{.underline} proposed for soliciting,
    evaluating, executing and post-award administration of subcontracts,
    including:

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a.  Qualifications and experience of contract management staff in the
    acquisition, award and monitoring of subcontracts, including
    financial monitoring and reporting and adherence to subcontract
    terms and conditions.

b.  Understanding of peer review processes and procedures, including
    principles for avoidance of review conflict of interest with
    subcontract proposals;

c.  Plans and procedures for developing solicitations, assembling
    qualified technical evaluation panels, conducting peer review of
    proposals received, and negotiating and awarding subcontracts in an
    objective and efficient manner; and

d.  Plans for closely monitoring and assessing technical, administrative
    and operational performance of subcontractors and implementing
    remedial actions to correct performance problems.

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4.  [Appropriateness of the proposed mix and balance of key
    personnel]{.underline} in relation to their specific
    responsibilities and time commitments.

> **CRITERION 4: FACITITIES AND OTHER RESOURCES** **25**
>
> The adequacy and availability of facilities, equipment and other
> resources necessary to carry out all contract activities, including,
> where appropriate, compliance with GLP and cGMP requirements, for the
> following:

1.  Laboratories for mechanistic studies and development of
    immune/surrogate markers;

2.  Nonclinical research and product development activities, including
    GLP facilities for the conduct of studies on product safety,
    toxicology, etc., and for the manufacture of pilot lots under cGMP
    when necessary; and

3.  Bioinformatics, data collection and validation functions.

**CRITERION 5: EXPANSION OPTION(S) 20**

> Demonstrated ability of the Principal Investigator to oversee and
> manage the expansion; adequacy of the resources and facilities to
> address expansion needs; adequacy of plans for subcontracting for the
> necessary expertise and capabilities to conduct work required in the
> expansion.

**TOTAL POSSIBLE POINTS [120]{.underline}**

7\. **PAST PERFORMANCE**[]{#mpastperformance .anchor} **FACTOR**

> An evaluation of offerors\' past performance information will be
> conducted prior to any communications with offerors leading to
> establishment of the competitive range. However, this evaluation will
> not be conducted on any offeror whose proposal will not be admitted to
> the competitive range on the basis of the results of the evaluation of
> factors other than past performance.
>
> The evaluation will be based on information obtained from references
> provided by the offeror, other relevant past performance information
> obtained from other sources known to the Government, and any
> information supplied by the offeror concerning problems encountered on
> the identified contracts and corrective action taken.
>
> The government will assess the relative risks associated with each
> offeror. Performance risks are those associated with an offeror\'s
> likelihood of success in performing the acquisition requirements as
> indicated by that offeror\'s record of past performance.
>
> The assessment of performance risk is not intended to be a product of
> a mechanical or mathematical analysis of an offeror\'s performance on
> a list of contracts but rather the product of subjective judgment by
> the Government after it considers relevant information.
>
> When assessing performance risks, the Government will focus on the
> past performance of the offeror as it relates to all acquisition
> requirements, such as the offeror\'s record of performing according to
> specifications, including standards of good workmanship; the
> offeror\'s record of controlling and forecasting costs; the offeror\'s
> adherence to contract schedules, including the administrative aspects
> of performance; the offeror\'s reputation for reasonable and
> cooperative behavior and commitment to customer satisfaction; and
> generally, the offeror\'s business-like concern for the interest of
> the customer.
>
> The Government will consider the currency and relevance of the
> information, source of the information, context of the data, and
> general trends in the offeror\'s performance.
>
> The lack of a relevant performance record may result in an unknown
> performance risk assessment, which will neither be used to the
> advantage nor disadvantage of the offeror.

8\. **EXTENT OF SMALL DISADVANTAGED BUSINESS**[]{#msdb .anchor}
**PARTICIPATION**

> **SDB participation will not be scored**, but the Government's
> conclusions about overall commitment and realism of the offeror's SDB
> Participation targets will be used in determining the relative merits
> of the offeror's proposal and in selecting the offeror whose proposal
> is considered to offer the best value to the Government.
>
> The extent of the offeror's Small Disadvantaged Business Participation
> Targets will be evaluated before determination of the competitive
> range. Evaluation of SDB participation will be assessed based on
> consideration of the information presented in the offeror's proposal.
> The Government is seeking to determine whether the offeror has
> demonstrated a commitment to use SDB concerns for the work that it
> intends to perform.
>
> Offers will be evaluated on the following sub-factors:

\(a\) Extent of commitment to use SDB concerns

> \(b\) Realism of the proposal
>
> \(c\) Extent of participation of SDB concerns in terms of the value of
> the total acquisition.

**SOLICITATION ATTACHMENTS INCLUDED WITH THE RFP**

The following pages[]{#attachmentstoRFP .anchor} include Attachments
applicable to this RFP as specified in SECTION J - List of Attachments

**PROPOSAL INTENT RESPONSE SHEET**

**RFP No.:** NIH-NIAID-DAIT-07-33[]{#proposalintent .anchor}

**RFP Title:** **Collaborative Network for Clinical Research on Immune
Tolerance**

Please review the attached Request for Proposals. Furnish the
information requested below and return this page by April 1, 2006. Your
expression of intent is not binding but will greatly assist us in
planning for proposal evaluation.

\[ \] DO INTEND TO SUBMIT A PROPOSAL

\[ \] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING REASONS:

**Company/Institution Name (print):**
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Address (print):**
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Project Director\'s Name (print):**
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Title (print):**
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Signature/Date:**
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Telephone Number and E-mail Address (print clearly):**

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**\*Name of individual to whom electronic proposal instructions should
be sent:**

**Name:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**Title:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**E-Mail Address:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**Telephone Number:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**Names of Collaborating Institutions and Investigators (include
Subcontractors and Consultants) (print):**

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

*(Continue list on a separate page if necessary)*

RETURN VIA FAX OR E-MAIL TO:

Office of Acquisitions, NIAID, NIH, DHHS

Room 3214

6700-B Rockledge Drive, MSC 7612

Bethesda, MD 20892-7612

Delivery service address: Bethesda, MD 20817

Attn: Erin M. Goldstein

RFP NIH-NIAID- DAIT-07-33

FAX# (301) 480-0972

Email : <eg108r@nih.gov>

**STATEMENT OF WORK**[]{#SOW .anchor}

**RFP-NIH-NIAID-DAIT-07-33**

**INTRODUCTION**: The purpose of this solicitation is to recompete the
"Collaborative Network for Clinical Research on Immune Tolerance"
(hereinafter referred to as the "Network") and to expand the
requirements to include nonclinical research and product development,
bioinformatics, and data collection, validation, and analysis. For
purposes of this solicitation and the resulting contract, immune
tolerance is defined as a selective lack of pathogenic immune responses
to relevant antigens (e.g., alloantigens, autoantigens or allergens) by
any of a variety of approaches, including: deletion, induction of
anergy, immune deviation, sequestration, or suppression. Approaches may
target antigen-specific pathways, costimulatory pathways, homing or
adhesion molecules, or other relevant molecules, and may use a variety
of agents, including antigens, peptides, altered peptide ligands,
monoclonal antibody blockade, cytokines, adjuvants, molecularly
engineered cells or tissues, DNA vectors or other relevant approaches.
Clinical research protocols that include minimally immunosuppressive
drug regimens will be allowable only in the context of efforts to
withdraw such agents as a component of an overall plan to achieve a
functional state of immune tolerance.

**SCOPE**: The scope of work to be performed by the Network includes:

> 1\. The design and conduct of Phase I-IV clinical trials of
> investigational approaches intended to lead to a functional state of
> immune tolerance in three clinical areas: autoimmune diseases; asthma
> and allergic diseases; and graft rejection of transplanted solid
> organs, tissues and cells;
>
> 2\. The design and conduct of mechanistic studies and the development
> of tolerance assays as integral components of the clinical trials
> undertaken, including establishing and directing a consortium of
> laboratories;
>
> 3\. Focused product development and nonclinical studies (e.g.,
> toxicology, pharmacology, and pharmacokinetics, etc.) essential for
> the subsequent evaluation of promising tolerance induction approaches
> in humans; and
>
> 4\. The provision of biostatistics, data collection, validation and
> analysis resources.

The Network will require strong leadership to provide for the overall
scientific direction, coordination and management of complex research
studies involving a large number of geographically distributed
facilities, subcontractors, and Network personnel. The Network will also
establish collaborations with pharmaceutical and biotechnology
companies, other NIH-sponsored clinical research programs, and private
research organizations to identify and evaluate tolerance induction
therapies, conduct mechanistic studies, and perform assays to assess the
induction, maintenance, and loss of tolerance.

**TECHNICAL REQUIREMENTS:**

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
under the terms of this contract, as needed to perform the Statement of
Work.

The functions to be performed by the Contractor are comprised of ten
task areas (Items I-X), and are briefly described below in the
**Overview** section. The work to be performed for each of these tasks
is described in the **Detailed Statement of Work** section below.

**OVERVIEW**:

I.  Strategic Plan and Research Agenda: Develop a Strategic Plan and
    Research Agenda to advance immune tolerance induction strategies
    through clinical trials, and to integrate studies of the underlying
    mechanisms of the induction, maintenance, and loss of tolerance.

II. Organizational Structure and Overall director and Coordination of
    Network Activities: Establish and manage a network of scientific and
    clinical investigators to include expertise in three areas: (1)
    transplantation, autoimmune

> diseases, and asthma and allergic diseases; (2) assay techniques to
> measure the induction, maintenance, and loss of tolerance; and (3)
> nonclinical development and production of candidate drugs.

III. Nonclinical Research and Candidate Drug Development: Design and
     conduct nonclinical research and product development activities for
     candidate drugs needed to accomplish the goals and objectives set
     forth in the Strategic Plan and Research Agenda. Such activities
     may include proof-of-principle studies, production,
     pharmacokinetics and pharmacodynamics studies, and nonclinical
     toxicity studies in suitable animal models. Manufacturing and
     laboratory studies shall be conducted under Good Manufacturing
     Practices (GMP) or current Good Laboratory Practices (cGLP), as
     appropriate.

IV. Clinical Trials: Implement the Strategic Plan and Research Agenda
    through the design and conduct of Phase I-IV clinical trials to
    evaluate the safety and efficacy of promising approaches to achieve
    immune tolerance in asthma and allergic diseases, autoimmune
    diseases, and transplantation.

V.  Mechanistic Studies and Laboratories: Establish and direct a
    consortium of laboratories to design and conduct mechanistic studies
    as an integral part of the Network clinical trials, using a broad
    range of assays to assess: (1) stage of disease and likelihood of
    progression; (2) effect of treatment on immunological status and/or
    clinical outcome; (3) maintenance of protective immunity; (4) safety
    of immunosuppressive withdrawal; and (5) identify and evaluate
    potential immune/surrogate markers of the induction, maintenance,
    and loss of tolerance.

VI. Bioinformatics, Data Collection, and Validation: Establish and
    maintain a data management and bioinformatics analytical resource
    with appropriate security and quality control measures. HHS is
    responsible for implementing a Department-wide information security
    program to assure that each information system and associated
    facility provides a level of security that is commensurate with the
    risk and magnitude of the harm that could result from the loss,
    misuse, disclosure, or modification of the information contained in
    the system. Each system\'s level of security shall protect the
    confidentiality, integrity, and availability of the information and
    comply with all security and privacy-related laws and regulations.
    The *HHS Information Security Program Policy* *and Handbook*, known
    as \"Secure ONE HHS\", provides a baseline of security policies for
    the Department. These policies apply to the Department, which
    includes Operating Division (OPDIV) and Staff Division (STAFFDIV)
    personnel, contractors, and other authorized users. All information
    technology related issues such as technical security, information
    security, personnel security, web management, application
    management, database management, electronic communications,
    electronic reporting, etc., defined within this contract is subject
    to the prescribed methods defined within \"Secure ONE HHS\".

VII. Collaboration with Clinical Research Programs and Organizations:
     Develop and implement a plan to collaborate with, including
     information-sharing, other NIH-sponsored clinical research
     programs, private organizations, and companies involved in research
     to advance the understanding of immune-mediated diseases.

VIII. Project Management

IX. Initial and Final Transition:

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A.  Initial Transition: Develop and implement an Initial Transition Plan
    to ensure the efficient and effective transfer of contract
    activities and resources.

B.  Final Transition Plan: Develop and implement a plan to transition
    studies, data, equipment and other contract resources upon
    termination of this contract to any successor organization(s)
    designated by the Government.

> X. Expanded Services through the Exercise of Option(s).

**DETAILED STATEMENT OF WORK:** Specifically, the Contractor and/or
subcontractors shall perform the following tasks:

I.  **STRATEGIC PLAN AND RESEARCH AGENDA**

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A.  Two (2) months after contract award, submit a draft Strategic Plan
    and Research Agenda for review and

> approval by the NIAID Project Officer. The Strategic Plan and Research
> Agenda shall:

1.  Describe the state-of-the-art of efforts to induce tolerance and
    define the underlying mechanisms in animal models and human studies.
    The discussion must include a description of safety concerns,
    knowledge gaps, and scientific opportunities relevant to the
    clinical application of tolerance induction strategies in human
    immune-mediated diseases and transplantation.

2.  Delineate approaches to tolerance induction for the prevention or
    treatment of asthma and allergic diseases, autoimmune diseases, and
    the prevention of immune-mediated rejection of solid organ, tissue
    and cell transplants.

3.  Delineate mechanisms underlying the induction, maintenance, or loss
    of immune tolerance.

4.  Describe the state-of-the-art of research on the identification,
    assessment,\
    and validation of immune/surrogate markers, biological samples
    (e.g., blood, tissue, cellular isolates), and new and existing
    techniques for measuring tolerant states in rodents, non-human
    primates and humans.

5.  Describe the knowledge gaps and opportunities relevant to the
    further development and improvement of immune/surrogate markers,
    samples and techniques, including the major sources of variability
    that may confound clinical applications (biological and sampling
    diversity, specimen handling, shipping, storage; and variability of
    detection procedures); validation against acknowledged disease
    endpoints; proposed strategies and methods for overcoming and/or
    reducing variability.

6.  Identify immediate and long-range goals of the Network, potential
    barriers to success, and potential solutions to overcome those
    barriers.

7.  Delineate approaches to identify and capitalize on opportunities for
    industry partnerships to accomplish the goals of the Network.

8.  Establish timelines and milestones to assess adherence to and
    success in meeting the major aims of the plan.

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B.  Following approval by the NIAID Project Officer, post the Strategic
    Plan and Research Agenda on the

> Network public website and notify the Network members that the
> document is available.

C.  At a minimum, conduct annual reviews of the Strategic Plan and
    Research Agenda to address new scientific, programmatic and fiscal
    developments; submit a concise report of recommended revisions to
    the NIAID Project Officer for review and approval. Following
    approval, revise the Strategic Plan and Research Agenda as required,
    post the revised version on the Network public website, and notify
    the Network members that the revised plan is available.

D.  Two (2) months after contract award, develop and submit, for review
    and approval by the NIAID Project Officer, a plan to identify and
    capitalize on opportunities for industry partnerships to accomplish
    the goals and objectives described in the Network Strategic Plan and
    Research Agenda. Revise and update the plan periodically, but no
    less than annually, to reflect new collaborative opportunities.

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II. **ORGANIZATIONAL STRUCTURE AND OVERALL DIRECTION AND COORDINATION OF
    NETWORK ACTIVITIES**

> The Contractor shall establish and direct the scientific, technical
> and operational infrastructure of the Network, consisting of a
> multi-institutional consortium of national and international experts
> in the areas of: (1) transplantation, autoimmune disorders, and asthma
> and allergic diseases; (2) assay techniques to measure the induction,
> maintenance, and loss of tolerance; (3) nonclinical research and
> product development; and (4) bioinformatics and data collection,
> validation and analysis. Specifically, the Contractor shall be
> responsible for planning, establishing, implementing and directing the
> organizational entities and activities delineated below.

A.  Two (2) months after contract award, develop and submit, for NIAID
    Project Officer review and approval, a plan for the scientific
    structure, management and coordination of all Network studies. The
    plan shall encompass the following: (1) priority setting procedures
    and criteria; (2) a process for developing, reviewing and approving
    concepts for proposed studies; (3) monitoring and evaluating
    progress and performance, including: augmenting the Network with
    additional institutions/organizations as may be necessary to
    capitalize on new scientific opportunities; discontinuing,
    temporarily or permanently, the services of subcontractors; and
    terminating or curtailing ongoing and planned research projects; (4)
    a process for allocating resources; and (5) a plan to determine the
    need for redirecting the research focus, including reallocation of
    funds, as needed to achieve the goals of the Strategic Plan and
    Research Agenda.

B.  The Network organizational structure must include, at a minimum, the
    two committees delineated below. Additional committees and
    subcommittees may be established to carry out the overall management
    and coordination functions listed in item C. below.

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1.  [Network Executive Committee]{.underline}: Provides scientific
    leadership and overall governance of the Network and directs the
    implementation of the Strategic Plan and Research Agenda. The
    composition and specific responsibilities of the Network Executive
    Committee include:

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a.  Chaired by the Network Principal (PI) and consisting of additional
    Network members, appointed by the PI, to provide leadership in each
    of the major medical/scientific areas critical to the success of the
    Network (i.e., nonclinical research and product development,
    clinical trial design and implementation; autoimmune diseases;
    asthma and allergic diseases; transplantation; immunological
    assessment of tolerance; bioinformatics and data analysis). The
    Network shall develop and implement a plan for the systematic
    rotation of membership of Network committees that ensures continuity
    of deliberations and processes. The NIAID Project Officer or
    designee shall be a voting member of the Network Executive
    Committee.

b.  Establishes Network priorities and serves as the main
    decision-making body. In addition, provides second-level review and
    approval of recommendations emanating from other Network committees
    and organizational entities. The Network Executive Committee shall
    also be responsible for communicating these decisions to the NIAID
    Project Officer, Network committees, and Principal Investigators of
    nonclinical studies, clinical trials, and mechanistic studies.

c.  Reviews and updates the Strategic Plan and Research Agenda on an
    annual basis.

d.  Establishes and maintains communication with the NIAID Project
    Officer regarding major Network activities, progress, obstacles and
    proposed approaches to overcome obstacles; submits requests,
    documents, manuscripts, reports, and other data and information for
    NIAID Project Officer review and approval.

e.  Plans and convenes three (3) 1-2-day Network Executive Committee
    meetings per year, in the Bethesda, MD area (or elsewhere, subject
    to approval of the NIAID Project Officer), and monthly
    teleconferences during months in which meetings are not held. The
    purpose of these meetings and teleconferences is to review
    governance and fiscal policies and procedures; progress of ongoing
    clinical trials, mechanistic studies, and nonclinical product
    development; progress of clinical studies in development; other
    performance assessments; and future plans.

f.  Two (2) weeks prior to each Network Executive Committee meeting,
    prepares an agenda for NIAID Project Officer review and approval;
    distributes agenda to Committee members and any ad hoc experts.

g.  Within one (1) week after each Network Executive Committee meeting
    or teleconference, prepares a list of participants and summary of
    discussions, action items and recommendations for review and
    approval by the NIAID Project Officer.

h.  Designs and implements a performance evaluation plan to include the
    criteria and measures to be used to assess Network performance.
    Conducts performance evaluations on an annual basis and prepares and
    submits a report on the results of each performance evaluation for
    NIAID Project Officer review and approval, including recommendations
    for approaches to improve efficiency, organizational structure,
    policies and procedures, adherence to established timelines for
    Network studies, and other factors relevant to the effective
    performance of Network activities.

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2.  [Network Steering Committee]{.underline}: Serves as the primary
    governing body for Network activities related to: clinical trials;
    nonclinical research and product development; mechanistic studies
    and tolerance assays; and bioinformatics/data analysis activities.
    Makes recommendations to the Network Executive Committee regarding
    implementation of new projects and direction of ongoing studies.

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a.  The composition of the Network Steering Committee shall include:

    i.  The Network Steering Committee Chair, designated by the Network
        Executive Committee;

    ii. The directors of the dedicated Network Clinical Trial Units (see
        Statement of Work Section III), other Network members, and
        ad-hoc representatives appointed by the Network Steering
        Committee Chair; and

    iii. Up to six (6) additional voting members appointed by the NIAID
         Project Officer. The NIAID-appointed members may include NIAID
         staff or ad hoc experts, as deemed necessary by the NIAID
         Project Officer.

b.  The responsibilities of the Network Steering Committee shall
    include:

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i.  Develops and implements a process for the solicitation and review of
    proposals for clinical trials, nonclinical research and product
    development, mechanistic studies, and tolerance assays. The process
    shall include a standardized form that provides at a minimum: the
    Principal Investigator name; study hypothesis, goals, and
    objectives; patient population(s) and proposed clinical trial sites,
    including documentation of access to the appropriate patient
    population(s); a statistical analysis plan; documentation of the
    availability of study product; and a description of any proposed
    collaborations, e.g., pharmaceutical companies, NIH-sponsored
    clinical research programs.

ii. Conducts reviews to assess the scientific merit and feasibility of
    all proposed studies; prepares written reports to document the
    results of all reviews; and communicates the results of reviews to
    the Network Executive Committee, including recommendations to the
    Network Executive Committee regarding Network support for clinical
    trials; nonclinical research and product development; mechanistic
    studies and tolerance assays; and bioinformatics/data analysis
    activities.

iii. Assumes responsibility for the oversight and direction of Network
     clinical trials; nonclinical research and product development;
     mechanistic studies and tolerance assays; and bioinformatics/data
     analysis activities.

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c.  The Network Steering Committee shall convene two (2) to three (3)
    meetings annually, of one to two (1-2) days in duration, in order
    to:

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i.  Review study proposals submitted by Network members and non-Network
    investigators; and

ii. Monitor progress of, and take remedial actions to address delays or
    other problems with Network-sponsored clinical trials; nonclinical
    research and product development activities; mechanistic studies and
    tolerance assays; and bioinformatics/data analysis activities.
    Meeting locations must be approved by the NIAID Project Officer. The
    Network Steering Committee Chair may convene additional
    teleconferences, videoconferences, or electronic reviews to avoid
    delays in addressing key issues that cannot be evaluated at the
    Network Steering Committee's regularly scheduled meetings.

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d.  One month prior to each Network Steering Committee meeting,
    teleconference or videoconference, the Network Steering Committee
    Chair shall prepare an agenda for NIAID Project Officer review and
    approval, and distribute the approved agenda to members of the
    Network Steering Committee and the Network Executive Committee.

e.  Within two weeks of completion of each Network Steering Committee
    meeting, teleconference or videoconference, the Network Steering
    Committee Chair shall prepare a list of participants and summary of
    discussions, action items, and recommendations for review and
    approval by the Network Steering Committee Chair.

f.  Prior to implementation, all clinical trial protocols must be
    reviewed by the NIAID DAIT Clinical Research Committee and approved
    by the NIAID Project Officer. The NIAID DAIT Clinical Research
    Committee is comprised of DAIT Medical Officers, Regulatory
    Officers, and Project Managers designated by the DAIT Associate
    Director for Clinical Research.

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C.  The Network shall also be responsible for day-to-day management and
    coordination with respect to clinical trials, core laboratories and
    assay studies, bioinformatics and data collection and analysis,
    ethical aspects of clinical trials and assay studies, conflict of
    interest, and publications and communications. The Network may
    establish subcommittees or project-specific working groups, or
    assign responsibility to key staff for the following activities:

    1.  Management of Clinical Trials

        a.  Oversee protocol development for clinical trials approved
            for implementation by the Network Executive Committee.

        b.  Assign Protocol Managers to oversee the implementation and
            conduct of each clinical trial and to serve as the primary
            contact to the NIAID medical monitors, NIAID project
            managers, and NIAID regulatory affairs officers.

        c.  Identify need for protocol amendments and or remedial
            actions to ensure adequate patient accrual and retention,
            adherence to protocol requirements and overall progress of
            clinical trials in collaboration with the NIAID project
            officer; make recommendation to the NIAID staff for
            appropriate actions.

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2.  Tolerance Assays and Laboratory Facilities

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a.  Establish and direct a consortium of institutions necessary to
    execute the laboratory component of the Network Strategic Plan and
    Research Agenda.

b.  Assess requirements for specific tolerance assays and laboratory
    facilities.

c.  Develop and disseminate standard operating procedures and operations
    manuals governing sample collection, shipment, and processing.

d.  Establish performance metrics for laboratory facilities, assess
    performance, and recommend and implement improvements and remedial
    actions when necessary.

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3.  Bioinformatics and Data Collection and Analysis

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a.  Assess requirements for data collection, validation, analysis and
    security.

b.  Develop and implement the Network bioinformatics and information
    management processes.

    4.  Review and Oversight of Ethical Aspects of Clinical Trials and
        Tolerance Assays

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a.  Develop and implement a process for the review of the ethical
    aspects of all clinical trial and tolerance assay proposals to
    identify potential ethical issues, and recommend modifications to
    resolve all such issues.

b.  Develop and implement periodic reviews of ongoing clinical trials
    for potential ethical issues and recommend modifications for the
    resolution of all such issues to the Network Executive Committee.

    5.  Conflict of Interest

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    a.  Develop and implement policies and procedures for
        identification, disclosure, reporting and management of
        potential and actual conflicts of interest for members of the
        Network and subcontractors. Conflict of Interest information
        must be reported to the NIAID Project Officer annually, and more
        frequently as required to address new or changing conflicts.

    b.  Update and modify Network conflict of interest policies and
        procedures as needed to remain in compliance with academic
        standards and other Federal regulations and policies described
        at <http://www.hhs.gov/ohrp/special/conflict.html>.

        6.  Publications and Communications

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a.  Develop and implement policies and procedures for authorship,
    preparation, review, and final approval of manuscripts resulting
    from Network studies, and for submission of manuscripts for
    publication in peer reviewed journals. The Network must submit
    manuscripts to the NIAID Project Officer for NIAID approval before
    submission to journals. The respective role and responsibilities of
    pharmaceutical companies in the publication review and approval
    process will be addressed in specific Clinical Trial Agreements
    (CTA), as appropriate.

b.  Establish and implement policies and procedures for publicizing
    Network solicitations, accomplishments, and developments to the
    scientific and lay communities and other relevant audiences.

c.  Design and maintain a publicly-accessible, Americans with
    Disabilities Act Section 508-compliant, internet-based website to
    provide information regarding Network activities for lay and
    scientific audiences and Network members. Information about Section
    508 can be found at
    [http://www.section508.gov](http://www.section508.gov/).

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III. **NONCLINICAL RESEARCH AND PRODUCT DEVELOPMENT**

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A.  As directed by the NIAID Project Officer, the Network may
    manufacture candidate drugs and/or conduct nonclinical safety and
    efficacy studies (e.g., toxicity, pharmacokinetic and
    pharmacodynamic) if needed to address priorities in the Network
    Strategic Plan and Research Agenda. The NIAID Project Officer or the
    Network may initiate proposals to manufacture candidate drugs and/or
    the conduct of nonclinical safety and efficacy studies. Proposals
    initiated by the Network must be submitted for NIAID Project Officer
    approval. All Network proposals for nonclinical studies and cGMP
    manufacturing will require consultation with NIAID staff and
    approval by the NIAID Project Officer. Approval will be based on
    well-documented needs (e.g., lack of an industry sponsor and/or need
    for additional nonclinical studies to meet regulatory requirements)
    or the high priority of clinical trial proposals based on the
    Network Strategic Plan and Research Agenda.

B.  For each clinical trial proposal, the Contractor shall:

    1\. Assess available data from nonclinical pharmacology and
    toxicology studies against International Conference on Harmonization
    (ICH) guidelines
    ([www.fda.gov/cder/guidance/index.htm](http://www.fda.gov/cder/guidance/index.htm)
    ). Determine if the studies, data and information are sufficient to
    meet Health Authority requirements and allow the proposed clinical
    trial to proceed. Identify and determine deficiencies, gaps, data
    and information that will be required prior to the initiation of a
    proposed clinical trial.

    2\. Assess the availability of study products for proposed clinical
    trials and additional nonclinical studies needed per the above
    assessments. Determine amount of product required to perform the
    proposed studies prior to initiation of the nonclinical studies or
    clinical trials.

    3\. If subcontracting is necessary, identify subcontractors to
    perform the nonclinical studies and identify the source of
    cGMP-grade study product supply:

    a.  Pharmaceutical drug manufacturer.

    b.  Contract manufacturer.

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4.  If a contract manufacturer is necessary, the Network shall
    subcontract for:

    a.  The manufacture of drug substance and drug product in accordance
        with cGMP;

    b.  Release testing of drug substance and drug product;

    c.  Stability testing of drug product and drug substance, as
        necessary;

    d.  Provision of documentation in formats necessary to meet FDA
        submission requirements; and

    e.  Oversight and audit of facilities and studies to ensure
        personnel, equipment and facilities are compliant with FDA
        regulatory requirements.

        5.  Prepare a Nonclinical Product Development Plan that outlines
            the cGMP manufacturing requirements for all nonclinical
            studies and clinical trials and the cGLP and non-cGLP
            nonclinical studies to be conducted. The Nonclinical Product
            Development Plan must propose a list of potential
            subcontractors capable of performing the required tasks.
            Submit the Nonclinical Product Development Plan to the NIAID
            Project Officer for review and approval. The Nonclinical
            Product Development Plan may include:

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a.  Determination of maximally tolerated dose (MTD);

b.  Determination of acute and subchronic system toxicity;

c.  Determination of relevant pharmacokinetic/toxicokinetic parameters;

d.  Bioavailability studies;

e.  Absorption distribution, metabolism, and excretion studies;

f.  Genetic toxicity, reproductive toxicity, and immunotoxicity studies;

g.  Immunogenicity studies;

h.  Biotransformation assays;

i.  Other safety and pharmacology assays and studies, as required;

j.  Drug concentration, identity, integrity, purity, potency, and
    contamination required for release for nonclinical or clinical use;
    and

k.  Assessment of post-production stability.

    6.  Solicit and evaluate technical and cost proposals from potential
        subcontractors and execute and manage subcontracts when
        necessary to carry out the activities called for in the
        NIAID-approved Nonclinical Product Development Plan.

    7.  Develop qualified assays to measure study product levels and/or
        immunogenicity in appropriate tissues to support nonclinical
        studies and clinical trials, as necessary.

    8.  As necessary, evaluate production and laboratory reports, or
        oversee and/or audit manufacturing and test facilities to ensure
        that personnel, equipment and facilities are compliant with the
        requirements of the relevant Health Authorities in the countries
        in which the proposed clinical trial study sites are located.
        All testing must be performed in accordance with cGLP
        regulations (21 CFR 58) unless otherwise specified by the NIAID
        Project Officer.

    9.  Evaluate the data resulting from the conduct of the above
        studies and draw relevant conclusions about pharmacokinetics,
        target organ(s) of toxicity, and likely human adverse reactions
        to the candidate drugs evaluated. Prepare and submit study
        reports to the NIAID Project Officer in formats compliant with
        the International Conference on Harmonization (ICH) guidelines
        ([www.fda.gov](http://www.fda.gov/)).

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IV. **CLINICAL TRIALS**

> Directly, or indirectly through subcontracts, the Contractor shall
> provide all personnel, resources, and facilities necessary to design
> and conduct Phase I-IV clinical trials to evaluate the safety and
> efficacy of immune tolerance strategies as specified in the Network
> Strategic Plan and Research Agenda. Specifically, the Contractor shall
> carry out the following tasks:

A.  Design and implement a protocol development process:

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1.  For each approved clinical trial, establish a Protocol Development
    Team to include the protocol Principal Investigator, Network
    Clinical Trials Management staff, Network investigators with
    expertise in the design and conduct of clinical trials and
    mechanistic studies, and NIAID staff to include the Medical Officer,
    Regulatory Affairs Officer, and Project Manager.

2.  The Network staff and protocol Principal Investigator shall be
    responsible for overall protocol development and shall assign
    responsibilities and establish specific timelines, milestones, and
    performance guidelines for protocol development.

3.  For each trial that includes mechanistic studies, the Protocol
    Development Team shall:

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a.  Define mechanistic study data that may be required for, or
    contribute to, interim safety, efficacy or utility analyses;

b.  Prioritize the proposed mechanistic studies for each trial; and

c.  Establish timelines for generating and reporting mechanistic data
    from each trial.

    B.  Data and Safety Monitoring:

        1.  Data and Safety Monitoring Plan: For each clinical trial,
            the Protocol Development Team shall develop a Data and
            Safety Monitoring Plan to ensure adequate monitoring of
            human subjects research. All Data and Safety Monitoring
            Plans shall be reviewed and approved by the designated
            ethics experts, committee or subcommittee as established by
            the Network Executive Committee, and revised as needed to
            address recommendations of the NIAID Data and Safety
            Monitoring Boards.

        2.  NIAID Data and Safety Monitoring Boards (DSMBs): As directed
            by the NIAID Project Officer, participate in and prepare
            materials for review by independent NIAID DSMBs. The
            Principal Investigator of each clinical trial shall present
            the final clinical protocol and the data and safety
            monitoring plan to the appropriate NIAID DSMB prior to study
            implementation, and shall also participate in the
            preparation of materials for and respond to questions and
            recommendations emanating from DSMB deliberations, including
            interim and final analyses of clinical study data.

            C.  Establish Clinical Trial Units (CTUs)

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1.  Dedicated Network CTUs**:** A dedicated group of CTUs shall be
    established from among the institutions participating in the
    scientific infrastructure of the Network to ensure maximum quality,
    consistency, timeliness and cost-efficiency in the conduct of
    Network clinical trials. Seventy-five percent (75%) of Network
    clinical trials must include dedicated CTUs and the majority of
    institutions participating in Network clinical trials must be from
    among the dedicated Network CTUs, unless otherwise directed by the
    NIAID Project Officer.

2.  Non-Network CTUs: CTUs at institutions outside of the Network
    scientific infrastructure may participate in the conduct of clinical
    trials with the approval of the NIAID Project Officer.
    Recommendations and procedures for the participation of non-Network
    CTUs in the conduct of clinical trials will be developed by the
    Network Executive Committee and submitted to the NIAID Project
    Officer for approval.

3.  Requirements for all CTUs: All CTUs participating in Network
    clinical trials must meet the following requirements:

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a.  Provide clinical investigators, nurse coordinators and other
    clinical and technical personnel experienced in the conduct and
    management of clinical trials in accordance with GCP standards and
    guidelines, including: patient screening, recruitment, enrollment
    and retention; informed consent; assessment and reporting of adverse
    events; collection and laboratory testing of protocol-specific
    patient specimens; receipt, storage, packaging, labeling and
    management of study products; collection, quality control and
    management of study data; and creation, maintenance and storage of
    research records, including participant files, source documents,
    regulatory files, subject identification information, clinical
    reports, and case report forms.

b.  Demonstrate the availability of a patient pool adequate to ensure
    the timely screening and enrollment of study participants.

    D.  Management and Oversight of Clinical Trials

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1.  Establish procedures and policies for the management and oversight
    of Network clinical trials.

2.  Develop and implement policies and procedures to ensure the timely
    and accurate completion of all clinical trials in compliance with
    NIH and other Federal or Health Authority regulations, requirements
    and policies.

3.  Provide protocol managers to facilitate study implementation,
    monitor patient accrual and retention, assess compliance with
    protocol requirements and adherence to study timelines, and report
    progress to designated NIAID Project Manager.

4.  Design and implement policies and procedures to ensure the safe,
    ethical and timely conduct of clinical research. Provide
    documentation of local Institutional Review Board approval for all
    clinical research.

5.  Provide ongoing training to clinical site personnel regarding
    protocol requirements and compliance with Federal regulations.

6.  Plan and conduct Investigator Kick-off Meetings at the start of each
    new clinical trial. The purpose of these meetings is to provide
    uniform study specific information to investigators and study
    personnel prior to study start-up.

7.  Develop and implement procedures for specimen collection, processing
    and shipping for each clinical trial and mechanistic. Train and
    qualify all appropriate laboratory and clinical personnel in these
    procedures for all approved protocols.

8.  Ensure that all clinical sites receive the required supply of study
    products for clinical trial initiation and conduct, and monitor
    supply throughout the duration of the clinical trial. Report to the
    designated NIAID Project Manager any changes in requirements for
    study products.

9.  Establish and maintain regular communications about clinical trial
    progress, report problems and concerns to the designated NIAID
    Project Manager.

10. Prepare and submit, for review and approval by the NIAID Project
    Officer, "Final Clinical Study Reports" for completed clinical
    trials within six (6) months of the database freeze. Formats of
    these reports must be compliant with ICH Guidelines (see
    [http://www.fda.gov](http://www.fda.gov/) ).

    V.  **MECHANISTIC STUDIES AND LABORATORIES**

        A.  Establish and direct a consortium of institutions and/or
            companies to:

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1.  Design and conduct studies to identify and evaluate potential
    immune/surrogate markers of the induction, maintenance, and loss of
    tolerance in autoimmune disorders, asthma and allergic diseases, and
    transplantation.

2.  Develop and submit for Network Executive Committee approval
    budgetary requirements for specific tolerance assays and
    laboratories.

3.  Serve as a central resource for all immune/surrogate marker and
    mechanistic studies conducted by the Network, including the
    development of protocol-specific instructions for clinical trial
    sites for the collection, storage, inventory, packaging and shipping
    of patient specimens to laboratories and the distribution of sample
    collection kits.

4.  In addition to Network-sponsored clinical trials, at the direction
    of the NIAID Project Officer, develop mechanistic studies for
    clinical trials conducted by other Federal agencies, private
    organizations and companies.

5.  At the request of the NIAID Project Officer, the Contractor shall be
    responsible for packaging and shipping biological materials
    collected during the clinical trials and mechanistic studies to
    other laboratories, Clinical Trials Units, or repositories. These
    will include blood and other body fluids and tissue samples.
    Specimens shall either be classified as Infectious Substances (the
    material is known or reasonably expected to contain pathogens that
    can cause disease in humans or animals) or diagnostic specimens. No
    materials on the Center for Disease Control and Prevention's (CDC)
    Select Agent List shall be collected or shipped
    (<http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm>). All
    material shall be classified, labeled, documented, packaged,
    shipped, and tracked according to Federal regulations and the
    International Air Transport Association (IATA) requirements
    (<http://www.iata.org/ps/publications/9065.htm>) for dangerous goods
    shipment. Samples must be shipped under appropriate cold storage
    conditions and in a timely fashion as specified in the clinical
    protocols or other documents.

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B.  Within three (3) months of contract award, develop and implement a
    process for the selection of laboratories and the development and
    validation of assays. This shall include the following:

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1.  Evaluate, prioritize and select assays and participating
    laboratories.

2.  Develop performance standards and metrics for assays and
    laboratories.

3.  Develop standard operating procedures for mechanistic assays
    including quality assurance and quality control.

4.  Ensure that laboratories meet GLP or equivalent standards or
    performance and establish appropriate performance standards where
    none exist (e.g., for emerging technologies). Within three months of
    contract award, develop for NIAID Project Officer review and
    approval, a plan to evaluate laboratories and to identify and
    remediate problems and deficiencies.

5.  Assess and implement new technologies and transitions from existing
    to new technologies.

6.  Disseminate current versions of assay protocols, standard operating
    procedures and performance standards to the research community via
    publications or posting on the Network website.

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C.  Develop and implement standard operating procedures for the conduct
    of mechanistic studies and reporting of study results, including:

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1.  Adherence to timelines for generating and reporting mechanistic data
    from each clinical trial as established by the Protocol Development
    Team.

2.  Timely reporting of mechanistic data required for interim and final
    analyses for each clinical trial.

    VI. **BIOINFORMATICS, DATA COLLECTION AND VALIDATION**

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A.  Establish a data management system for the collection, storage,
    archiving, and exchange of clinical and mechanistic data from
    multiple sources and make these data accessible to Network staff and
    investigators, and NIAID staff. Specifically, the Contractor shall:

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1.  Design, implement and maintain a scaleable architecture for a widely
    distributed, networked system for biomedical and scientific data
    collection, storage, and exchange. Data collected will be of many
    types, including but not limited to, genetic, cellular, molecular,
    and clinical data.

2.  Utilize the latest advances in software engineering and computer
    sciences and translate those advances into practical tools that are
    easily used by the target users, including Network staff and
    investigators, and NIAID staff, in this project. The software
    development to be conducted under this task shall, whenever
    possible, integrate rather than displace existing applications.

3.  Using good software development practices, rapidly develop software
    for the capture, analysis, query, and storage of scientific data.

4.  Build a scalable network and computer infrastructure to meet end
    user needs.

5.  Create an integrated electronic data repository containing relevant
    scientific data for each research subject or patient sample,
    including but not limited to, clinical, diagnostic, and laboratory
    information. All such data shall be maintained in integrated
    electronic databases in a format that permits rapid and efficient
    production of files for analysis. Verify and validate all data in
    the data repository in collaboration with the originating
    laboratories and the clinical Data Management Contract Research
    Organization (CRO).

6.  Develop, implement, and/or disseminate software applications to make
    data accessible to the scientific community in accordance with the
    timelines detailed in the NIH Data Sharing Policy
    <http://grants.nih.gov/grants/policy/data_sharing/index.htm> ).

7.  Within six (6) months after contract award, develop standard
    operating procedures for the collection, storage, archival, and
    exchange of biomedical data to participating laboratories and the
    Data Management Contract Research Organization.

8.  Provide technical assistance in the collection, submission,
    exchange, and analysis of data to participating laboratories,
    clinical sites, and Data Management CRO.

9.  Design and implement a reliable system of quality control applied to
    all data and media.

10. Within six months of contract award, develop and implement a
    long-range plan for the long-term maintenance and survival of the
    data and data system. Integrate system updates according to changing
    technological advances and user needs.

11. Fully document systems and software developed.

12. Ensure that software applications and standards facilitate the
    interoperability of the data systems and/or the portability of data.

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B.  Establish a Sample Tracking and Inventory System for the Processing
    of Laboratory Samples

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1.  Establish an end-to-end automated bar coded system for tracking
    laboratory samples from the time the sample is obtained from a
    patient to the time the results from the sample are stored in the
    final production database.

2.  Incorporate the ability to generate audit trails and reports from
    the system at any point in the process to determine the status of a
    specific sample or batch of samples and to identify problems in the
    processing pipeline.

3.  Ensure the quality and integrity of the data generated throughout
    this process.

    C.  Provide to participating Principal Investigators for Network
        clinical trials and mechanistic studies access to data and
        ongoing bioinformatics analytical support for the primary and
        secondary analyses of data. This support shall include:

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1.  Provide scientific leadership in the development and review of
    cutting edge design and analytic approaches that fully utilize the
    network of clinical sites, laboratories, and specimen repositories.
    Specifically, provide input into the development, review, and
    implementation of concepts and sub-studies by:

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a.  Delineating research questions that can be addressed with study data
    in areas of high priority for the accomplishment of Network
    scientific objectives.

b.  Selecting appropriate study populations and control or comparison
    groups to address the research questions.

c.  Selecting and developing alternative study designs and data analysis
    plans, including approaches for limited sample size, and delineating
    the compromises that must be made in the face of immutable
    circumstances (e.g., small sample size due to rarity of disease or
    procedure).

d.  Assessing the feasibility of accessing appropriate data for
    retrospective analyses and for recruiting and retaining adequate
    numbers of study participants for proposed sub-studies.

e.  Ensuring that the type, number and volume of participant samples
    required are available and consulting clinical sites on the
    appropriate collection, testing, storage, and shipping of
    participant samples

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2.  Conduct data analyses of mechanistic study data and combined
    clinical and mechanistic data and participate in the preparation of
    and manuscripts. Data analyses for clinical trials alone will be
    handled by the Data Management Contract Research Organization (CRO).
    The Network shall receive clinical data sets from the Data
    Management CRO for integration with the mechanistic data. These
    combined data will be the source for integrated mechanistic and
    clinical analyses. Formats and frequency for transfer of the
    clinical data to the Network will be determined at the time of
    contract award.

The NIAID has awarded separate contracts to assist the Network with
protocol development, implementation, monitoring progress, and data
analysis. Refer to Appendix E for more information regarding support
through such contracts in the following areas: (1) design of clinical
protocols, including statistical parameters and patient data and patient
samples to be collected; (2) preparation of Investigational New Drug
Applications (INDs), adherence to regulatory requirements of the Health
Authorities or equivalent including reporting of adverse events,
clinical site monitoring, ensuring the confidentiality of patient data,
documentation of Institutional Review Board approval of protocols, etc;
(3) development of procedures for obtaining patient data from clinical
sites, establishment and maintenance of a consolidated database for all
clinical trials, and data management and quality assurance; (4) analysis
of clinical study data; and (5) distribution of investigational agents
to clinical sites.

3.  In addition, the Contractor shall:

    a.  Provide staff with expertise in the following areas:

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i)  Theoretical statistics

ii) Epidemiology

iii) Data modeling, particularly longitudinal data

iv) Methodologies in controlling for effects of, yet optimizing,
    repeated measures

v)  Marginal structural modeling

vi) Causal inference, including appropriate use of propensity scores and
    instrumental variables

vii) Exploratory data analysis and robust methods in determining
     population and person-level effects

     b.  Develop *a priori* data analysis plans as well as plans for
         secondary analyses.

     c.  Develop innovative statistical methods to address scientific
         questions posed by the Network investigators.

     d.  Identify statistical parameters substantiating the choice of
         statistical tests employed in the techniques and methodologies
         used to conduct data analyses.

     e.  Maintain a tracking system to document the analytic progress
         and status of Network research proposals.

     f.  Maintain and distribute to all Network investigators and the
         NIAID Project Officer, a list of all publications, manuscripts
         in progress and presentations using data from Network studies.

     g.  Make drafts of manuscripts available for review (electronically
         or in hard copy) by the NIAID Project Officer, NIAID Medical
         Monitors and the NIAID Regulatory Affairs Officers at the time
         they are circulated to co-authors, and when the final
         manuscripts are submitted for publication.

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D.  Develop and implement a system for monitoring security and system
    performance with the aim of maintaining data and system security and
    integrity, as well as high levels of service to Network staff and
    investigators and NIAID staff. Specifically, the Contractor shall:

    1.  Develop a program for monitoring use of the system.

    2.  Develop and implement a plan to protect data derived from human
        subjects in compliance with current Federal regulations.

    3.  Test the system according to best and standard practices in
        computer and engineering services to ensure that it is
        performing according to service levels agreed to at the time of
        contract award.

    4.  Report to the NIAID Project Officer or designee and the Network
        Executive Committee any potential problems with the system;
        repair problems within seventy-two (72) hours of problem
        identification. Reports should be made to the NIAID Project
        Officer or designee and the Network Executive Committee in a
        timely way.

    5.  Inform and train designated Network system security staff in the
        security procedures of the system.

    6.  Develop, implement, and maintain security requirements,
        including:

        a.  An Automated Information System Security Profile, which at a
            minimum shall include: the System\'s Security Plan; the Risk
            Analysis Plan; and the Continuity of Operations Plan (also
            known as the Contingency Plan).

        b.  Continuity of Operations Plan testing shall be conducted and
            the results recorded at least every six months. Maintain a
            log or record of the results from testing the Continuity of
            Operations Plan, any existing plans, and progress reports
            for implementing additional security safeguards and
            controls; and the system access authorization list. The
            profile shall be kept up-to-date for review and potential
            inspection upon demand by the U.S. Department of Health and
            Human Services and/or the NIH. Upon request, copies of
            specified profile documents shall be presented to NIH/DHHS
            for its own system\'s security reporting purposes.

        c.  The preparation and submission, for NIAID Project Officer
            approval, of a Risk Analysis Plan following the guidance
            given in the NIH Security Plan Template
            (<http://irm.cit.nih.gov/security/secplantemp.doc>). The
            Risk Analysis Plan is to be maintained and updated every
            three years, or in advance of implementing major system
            modifications or enhancements.

        d.  The preparation and submission of an annual Systems Security
            Plan, following the instruction in OMB Bulletin 90-08, for
            review and approval by the NIAID Project Officer and the NIH
            System Security Officer
            (<http://irm.cit.nih.gov/itmra/omb90-08.html>).

        e.  The development and maintenance of an up-to-date Continuity
            of Operations Plan following the guidance in the NIH
            Security Plan Template
            (<http://irm.cit.nih.gov/security/secplantemp.doc>). At a
            minimum, the Continuity of Operations Plan shall cover
            emergency operations, backup operations, and recovery plans
            to ensure continuous operations of the system\'s facility.

        f.  Plans, procedures, and a recommended schedule for
            implementation of security safeguards required to satisfy
            the anticipated conditions of acquiring data from clinical
            and basic research study sites. This includes data integrity
            and security during electronic transmission or during
            transit from the sites to the data repository if
            non-electronic data transmission is used. All patient
            identifiable data are subject to the Privacy Act and Health
            Insurance Portability and Accountability Act of 1996
            ("HIPAA") regulations. Plans, procedures, and schedules must
            be reviewed and approved by the NIAID Project Officer or
            designee.

        g.  Provision for the appropriate labeling, storage, handling,
            and disposal of sensitive or controlled data, media, and
            output.

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7.  Collaborate and coordinate activities in conjunction with other
    NIAID and bioinformatics groups:

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a.  Deposit all clinical and mechanistic data to the NIAID-supported
    Bioinformatics Integration Support Contract (BISC) data repository
    (<http://www.niaid.nih.gov/research/bisc.htm>). Clinical data will
    be deposited once the clinical study has been closed and the initial
    findings have been published. In accordance with the NIH Data
    Sharing Policy
    (http://grants.nih.gov/grants/policy/data_sharing/index.htm), both
    clinical and mechanistic data will be deposited to BISC no later
    than sixty (60) days after the initial publication of study results.

b.  All Network data will have all patient identifiers removed before
    deposition to BISC. The BISC system is able to accept most standard
    file formats that are produced in scientific research. The BISC is
    responsible for mapping data coming from the Network studies into
    the BISC data model. The format of the data files and of the data
    transfer methods from Network to BISC will be determined at the time
    of award.

c.  Work with BISC to develop standards and formats that will lead to
    ease of interoperability among bioinformatics tools, databases and
    software developed by the Network, BISC and other NIH-funded
    programs.

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VII. **COLLABORATION WITH NIH-FUNDED CLINICAL RESEARCH PROGRAMS AND
     OTHER ORGANIZATIONS**

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A.  The Contractor shall collaborate with and disseminate research
    information to other NIH-sponsored networks, private organizations,
    foundations, and companies involved in research on immune-mediated
    and infectious diseases. Within six (6) months of contract award,
    the Contractor shall:

    1.  Develop policies and procedures governing collaborations with
        other clinical research programs and organizations.

    2.  Develop a written plan that delineates ongoing collaborations
        with other clinical research programs/organizations and plans
        for future collaborations with these and other entities. The
        plan must specify the role of Network investigators and staff in
        ongoing and proposed collaborations, and the resources to be
        shared or provided between the collaborating organizations,
        including:

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a.  The proposed resources, personnel, and services to be provided to,
    or shared with, the other research entities and what biological
    samples, personnel, services or remuneration, if any, the
    collaborating organizations will provide to the Network;

b.  The type of mechanism to be used to formally engage in the
    collaboration, e.g., Memorandum of Understanding (MOU), subcontract,
    or Cooperative Research and Development Agreement (CRADA);

c.  If financial remuneration is planned, a complete description of the
    estimated charges to this contract and the costs to be charged to
    the collaborating research entity.

d.  Management of intellectual property developed through these
    collaborations;

e.  Methods to be used for dissemination of the research findings
    developed through the collaboration.

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3.  Execute, and manage agreement mechanisms and subcontracts needed to
    implement such collaborations. The NIAID Project Officer and NIAID
    Contracting Officer must approve the Network collaboration plan and
    financial arrangements prior to entering into an agreement or
    research collaboration.

    VIII. **PROJECT MANAGEMENT**

          A.  **Overall Project Management**. Provide a technical and
              administrative infrastructure to ensure the efficient
              planning, initiation, implementation and management of all
              projects carried out under this contract and effective
              communications with the NIAID Project Officer and the
              NIAID Contracting Officer. This infrastructure shall
              include a Principal Investigator (PI) with responsibility
              for overall project management and communications,
              tracking, monitoring and reporting on project status and
              progress, and recommending modifications to project
              requirements and timelines, including projects undertaken
              by subcontractors. The PI shall devote not less than 35%
              effort to this contract. This infrastructure shall also
              include Protocol Managers to oversee the implementation
              and conduct of clinical trials and serve as the primary
              contact to NIAID staff, as well as administrative staff
              with responsibility for financial management and financial
              reporting on all activities conducted by the Contractor
              and subcontractors.

          B.  **Financial Management**. Manage and track the ITN budget
              and provide updated budget reports, including actual and
              projected expenditures. Reported categories shall
              include,: total direct labor; accountable personal
              property; supplies; travel; lease and rental consultants;
              clinical trials; tolerance assays; subcontracts; service
              agreements for laboratories and laboratory facilities;
              vendor agreements; and prime contract and subcontract
              indirect rates and costs.

          C.  **Subcontract Execution, Management and Reporting.** The
              Contractor shall manage the subcontracting activity and
              shall ensure that the award and management of subcontracts
              is in accordance with FAR Clause 52.244-2. Specifically,
              the Contractor shall carry out the following:

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1.  Execute and manage subcontracts, oversee the technical,
    administrative and operational activities of subcontractors on a
    daily basis, including auditing subcontractor facilities, services,
    financial expenditures, and track deliverables and reporting
    requirements;

2.  Assess and provide quarterly technical reports on subcontractor
    performance and progress toward achievement of defined milestones;
    and identify and resolve problems with subcontractor performance;

3.  Ensure that subcontractor personnel, equipment and facilities are
    compliant with regulatory requirements in effect throughout the
    contract period;

4.  Ensure the complete and effective transfer of technology by the
    subcontractors to the Contractor, the United States Government, or a
    third party as designated by the NIAID Project Officer; and

5.  Perform all necessary transition and closeout functions on each
    subcontract.

6.  For subcontracts exceeding \$500,000, the Contractor shall establish
    technical review panels for the purpose of evaluating the technical
    portion of subcontract proposals. The technical review panel shall
    provide its recommendations to the Contractor. The Contractor shall
    base its selections for subcontractor awards on the panels'
    recommendation and forward the subcontract and all required
    supporting documentation to the NIAID Project Officer and
    Contracting Officer for final approval.

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IX. **INITIAL AND FINAL TRANSITION**

> **A. Initial Transition.** The Contractor shall develop and submit,
> within six (6) weeks of contract award, a draft Initial Transition
> Plan for receipt of work in progress by the ITN and describe how all
> activities, including clinical trials in development, implementation,
> follow-up, or analysis phases, will be continued and/or completed
> after contract award. The Initial Transition Plan must:

a.  Describe how the Contractor proposes to communicate with and receive
    from the incumbent contractor information regarding work in
    progress;

b.  Propose detailed plans for the continuation and completion of all
    work in progress and for the movement of other contract-generated
    resources, including equipment, scientific and clinical data,
    patient samples, etc.

c.  Identify the staff assigned to the initial transition and describe
    their roles, responsibilities, and qualifications; and

d.  Include a plan to establish subcontracts, consulting agreements,
    purchase orders/agreements, confidentiality/intellectual property
    agreements, and leasing agreements in an expedited manner to enable
    the continuation and/or completion of clinical trials and other
    research activities without interruptions or delays.

> After NIAID Project Officer approval of the draft Initial Transition
> Plan, the Contractor shall implement the plan to ensure completion of
> the transition within twelve (12) months of contract award.
>
> **B. Final Transition**

1.  The Contractor shall submit a Final Transition Plan to ensure the
    orderly transition of the contract data, equipment, animals and
    other materials to Government designated locations, grantees, or
    contractors. The Plan shall be submitted six (6) months prior to
    contract completion and shall be subject to review and revision by
    the NIAID Project Officer.

2.  Develop and execute the Final Transition Plan during the phase-out
    and transfer of the contract to the Government or to a successor
    contractor:

    a.  The Final Transition Plan shall provide for the orderly transfer
        of all or part of this project to a designated Contractor or the
        Government at the end of the contract period. The Final
        Transition Plan shall include an estimate of transition costs,
        timeframe to completion, and the staff required to execute a
        successful and timely transition. In addition, the Final
        Transition Plan shall include:

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i)  A description of how all databases, data/information, equipment and
    other materials identified by NIAID Project Officer will be
    transferred.

ii) A schedule for delivery of data, datasets, databases, and/or systems
    developed under this contract to the NIAID Project Officer.

iii) A list of open clinical trials and actions needed to ensure their
     continuation or completion during the transition period.

iv) A list of incomplete remedial site actions or pending safety issues
    and plans for their resolution.

v)  A list of facilities, leases, maintenance contracts, and equipment
    support provided and any scheduled support to be provided during the
    transition period.

vi) A list of subcontracts with a transition plan to either continue
    through transition to another subcontractor or terminate if the
    subcontract is at its completion date. If the subcontract is
    transitioned to a new organization, all subcontracts must be
    terminated to coincide with the completion date of the current
    Network prime contract. The new contractor must negotiate new
    subcontract agreements.

    b.  Should the responsibilities of the Network be transferred to a
        successor organization or to the Government, the Contractor
        shall provide the following deliverables not later than the
        completion date of the contract:

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i)  A cleaned and edited data set, on media and in a format to be
    determined at the time of delivery by the NIAID Project Officer, and
    copies of all data management tools, including data documentation,
    data dictionaries, and data entry software and editing programs to
    allow reading and analysis of the data.

ii) All computer programs used for reading, cleaning, manipulating,
    graphing, and analyzing data and programs used for generating new
    datasets.

iii) An audit trail of all raw data corrections, hard copies of the
     original data collected from study participants from all studies
     supported by this contract, and all logs and other records related
     to data collection, entry, editing, analysis, and transfer.

iv) Final summaries of analyses performed by the Contractor during the
    contract period.

v)  All electronic files in a well-documented format to a location
    specified by the NIAID Project Officer.

> **X. EXPANDED SERVICES THROUGH EXERCISE OF OPTION(S)**

A.  In addition to the tasks outlined in the above Statement of Work to
    be provided for the basic requirement, Option(s) for additional
    tasks under the contract may be exercised. The Government
    anticipates a potential need for the following additional tasks
    during the course of the contract's established seven year period of
    performance:

    1.  Nonclinical research and product development

    2.  Clinical trials

    3.  Mechanistic studies

    4.  Bioinformatics support

> Such an increase in the Contractor's activities may be activated, at
> the discretion of the Government, as an Option. Under each Option for
> expansion of services in a task area, the Contractor shall provide the
> following:

1.  EXPANSION PLAN:

> The Contractor shall develop a plan for the necessary services called
> for to exercise an option, including all tasks involved in
> implementing the expansion. Because the additional tasks fall within
> items I-IX of the Statement of Work, the Government does not
> anticipate a substantial increase in Network staff or infrastructure
> required to implement the expansion. Accordingly, with the exception
> of Option 4, above (Bioinformatics Support), the plan should NOT
> include modifications to the organizational structure, personnel,
> management procedures or infrastructure of the Network.

2.  PLAN IMPLEMENTATION:

> Based on NIAID Project Officer recommendation to implement the
> expansion plan, the NIAID Contracting Officer will authorize the
> exercise of each Option through a Modification to the contract. Each
> option may be exercised more than once. More than one, but not more
> than [ten]{.underline} [(10)]{.underline} Options may be exercised in
> any year.
>
> **\[END OF STATEMENT OF WORK\]**

**Collaborative Network for Research on Immune Tolerance**

**RFP-NIH-NIAID-DAIT-07-33**

**[APPENDIX A]{.underline} -** []{#APPENDIXA .anchor}**ADDITIONAL
TECHNICAL PROPOSAL INSTRUCTIONS**

**FORMAT FOR TECHNICAL PROPOSAL -- [TABLE OF CONTENTS]{.underline}**

+-----------------------------------------------------------------------+
| **It is strongly recommended that offerors use the following template |
| as the [Table of Contents]{.underline} for the technical proposal.    |
| All information presented in the technical proposal should be         |
| presented in the order specified below.**                             |
|                                                                       |
| The following additional technical proposal instructions reflect the  |
| requirements of the RFP and are meant to provide additional           |
| instructions as well as a uniform format for technical proposals. The |
| information requested in these instructions should be used as a guide |
| for formatting and preparing the proposal.                            |
|                                                                       |
| Offerors are advised to give careful consideration to the statement   |
| of work, all reference material, appendices and attachments, the      |
| technical evaluation criteria, and, the RFP as a whole, in the        |
| development of their proposal.                                        |
|                                                                       |
| Offerors who propose subcontracts to perform portions of the          |
| statement of work should clearly identify the specific tasks for      |
| which they plan to utilize subcontractors, as well as the method and  |
| level of integration between the prime and subcontractor(s), and the  |
| expected advantages of such an approach.                              |
|                                                                       |
| Offerors are reminded that the total page limit for the               |
| **[entire]{.underline}** technical proposal package is 300 pages,     |
| including appendixes providing standard operating procedures,         |
| operation manuals, policies and procedures, curriculum vitas, and     |
| selected references for publications.                                 |
+-----------------------------------------------------------------------+

**APPENDIX A- ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS**

**[TECHNICAL PROPOSAL -- TABLE OF CONTENTS]{.underline}**

**SECTION 1: TECHNICAL PLAN**

> **PART A: STRATEGIC PLAN AND RESEARCH AGENDA**

1.  The Technical Proposal must include a proposed Strategic Plan and
    Research Agenda for the Network that address the following:

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a.  Identify the immediate and long-range goals of the proposed Network,
    potential barriers to success, and solutions to overcome identified
    barriers.

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b.  A discussion of the state-of-the-art of efforts to induce tolerance
    and define the underlying mechanisms in animal models and human
    studies; a description of safety concerns, knowledge gaps, and
    scientific opportunities relevant to the clinical application of
    tolerance induction strategies in autoimmune and allergic diseases
    and transplantation.

c.  A prioritized list or table of clinical trials and mechanistic
    studies proposed to be conducted by the Network. Trials of minimal
    immunosuppression are acceptable if they involve immunosuppression
    withdrawal as an approach for achieving clinical tolerance. Include
    the rationale for selection and ranking of specific approaches,
    taking the following into consideration: the strength of preliminary
    data; the importance of the hypotheses to be tested; the relevance
    of anticipated findings to more than a single disease or condition;
    proposed timelines and milestones for proposed clinical trials and
    mechanistic studies; the feasibility of designing, implementing and
    completing proposed clinical trials and mechanistic studies; access
    to adequate numbers of patients; safety and equipoise; availability
    of study products and other essential reagents; level of industry
    support; and budgetary and time constraints. The Government
    recognizes that the ranking of opportunities and priorities will
    change with future developments.

d.  Plans for assessing adherence to the plan and success in meeting the
    major aims of the plan, and a discussion of how the Network will
    address new scientific or programmatic developments/objectives
    through periodic review and revision of the Plan. Such reviews will
    be one component of the broader periodic assessment of Network
    progress in meeting the objectives and milestones outlined in
    Sections I to VIII of the Statement of Work.

> The Government recognizes that proposed clinical trials, mechanistic
> studies, and assays can be based only on currently available
> knowledge. Therefore, the award of this contract does not commit the
> Government to approve or implement any of the clinical trials and
> mechanistic/assay studies proposed in the Strategic Plan and Research
> Agenda.
>
> **PART B: ORGANIZATIONAL STRUCTURE AND OVERALL MANAGEMENT AND
> COORDINATION**

1.  The Technical Proposal must include a plan for the organizational
    structure and membership of the Network, including policies and
    procedures to meet the scientific, technical and
    functional/operational requirements outlined in item II. of the
    Detailed Statement of Work. A broad range of scientific, clinical
    and program management expertise will be necessary to carry out the
    requirements of this solicitation. The Government recognizes that no
    single institution or organization will have the expertise and
    facilities necessary to perform all the requirements of the and,
    therefore, it will be necessary for the Prime Contractor to
    subcontract portions of the work to be performed. It is also likely
    that the Network's leadership will require multiple scientific and
    clinical investigators in various disease areas. The Government also
    recognizes that the specific processes to be used by the Network to
    manage and coordinate studies, establish priorities, and redirect
    scientific and fiscal resources will be developed fully after
    contract award. All proposed plans, procedures and policies should
    address the point outlined immediately below in the Technical
    Proposal and will be subject to review, approval and modification,
    if necessary by the Government post award.

    a.  Describe the proposed Network structure and membership and the
        specific responsibilities, tasks, decision-making processes, and
        reporting lines of authority for all proposed key organizational
        entities and key scientific and technical personnel for both the
        Contractor and any subcontractors. This includes the Network
        Executive Committee, the Network Protocol Review Committee, and
        any other committees or subcommittees proposed, as well as the
        organizational structure and responsibilities, policies and
        procedures for the overall management and coordination of
        clinical trials, tolerance assay studies and Laboratories,
        bioinformatics and data collection, validation and analysis,
        review and oversight of ethical aspects of clinical trials and
        tolerance assay studies, and conflict of interest. The use of
        tables, schematics, and flow charts to clarify roles and
        responsibilities is highly recommended.

    b.  Propose a plan for the evaluation of the performance of the
        Network. The plan must include criteria, measures and methods to
        objectively evaluate the effectiveness, productivity, and
        overall performance of the Network and Network subcontractors.

> **PART C: NONCLINICAL RESEARCH AND PRODUCT DEVELOPMENT**

1.  The government anticipates that to address this requirement, the
    Network will independently, or through subcontractors, access a
    range of product development expertise and services (e.g., cGMP
    manufacture; nonclinical safety and efficacy assessments;
    pharmacokinetics, absorption, distribution, metabolism and excretion
    assessments; cGLP nonclinical toxicology studies). The required
    product development activities will be identified and delineated in
    a Nonclinical Product Development Plan tailored to each proposed
    drug candidate to be evaluated in Network clinical trials.

2.  Although the study products to be assessed and the type and extent
    of nonclinical studies or product manufacturing that will be
    required cannot be defined at this time, the Offerors must provide
    in the Technical Proposal a detailed discussion of:

    a.  Methods, techniques and approaches to be utilized to assess the
        availability and quality of study products;

    b.  The range of manufacturing activities and nonclinical studies to
        be performed by the Network or its subcontractors; and

    c.  The range of product release and stability testing criteria to
        be used by the Network or its subcontractors.

3.  The Technical Proposal must document the Network's capabilities to
    address the activities outlined in the Nonclinical Product
    Development Plan, including:

    a.  Directly, or through subcontractors, manufacturing and/or
        testing of study products;

    b.  Overseeing and auditing nonclinical testing and/or cGMP
        manufacturing facilities to ensure timely, on-budget task
        completion and compliance with cGLP and/or cGMP requirements;
        and

    c.  Meeting regulatory requirements of the relevant Health
        Authorities;

4.  Describe the process of identifying, qualifying, auditing, and
    subcontracting with the necessary nonclinical testing or
    manufacturing facilities.

> **PART D: CLINICAL TRIALS**

1.  Protocol review and selection

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a.  Describe proposed policies and procedures for the evaluation,
    prioritization and approval of concept proposals for further
    development by the Network. Such policies and procedures must ensure
    that Network clinical trials address the priorities outlined in the
    Network Strategic Plan and Research Agenda and apply to proposals
    developed internally by the Network investigators and to proposals
    submitted by non-Network investigators.

b.  Describe policies and procedures for review and development of full
    protocols.

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2.  Protocol implementation

    a.  Describe proposed policies and procedures for the selection of
        clinical trial sites, including dedicated Network Clinical Trial
        Units (CTUs) and non-Network CTUs. Describe proposed policies
        and procedures for the conduct and monitoring of clinical trials
        (e.g., adherence to established timelines for study initiation,
        patient recruitment and enrollment, and study completion,
        adherence to GCP standards and practices and to
        protocol-specific requirements, management and quality control
        of study data, collection and laboratory analysis of patient
        specimens, etc.).

    b.  Identify and describe the capabilities of the proposed dedicated
        Network CTUs (i.e., membership, organization, and lines of
        authority); delineate the proposed criteria to be used to select
        dedicated Network CTUs and to propose recommendations for future
        modification of the CTU membership as may be required to meet
        performance standards and timelines.

    c.  Describe criteria, policies, and procedures for determining the
        need for and recommending to NIAID the expansion, curtailment,
        or discontinuance of clinical trials, including the
        participation of individual CTUs, taking into account adherence
        to milestones, availability of funds, availability of study
        product, and changing priorities and scientific opportunities.

3.  Roles and Responsibilities of NIAID Staff and NIAID-Funded Clinical
    Research Support Services Contractors

> The primary role of NIAID staff will be to facilitate, but not to
> direct, protocol selection, development and implementation activities.
> NIAID staff and ongoing NIAID clinical research support contracts will
> provide a broad range for services to the Contractor for the design,
> development, implementation and analysis of Network studies.
> Specifically,

a.  Regulatory Affairs**:** NIAID will provide regulatory guidance
    throughout protocol development and study conduct. In most
    instances, and at its discretion, NIAID will serve as the sponsor of
    Investigational New Drug Applications (INDs) or equivalent clinical
    trial applications outside the U.S. or delegate this role to
    industry partners. As IND sponsor, NIAID will be responsible for
    tracking and reporting of Adverse Events to appropriate Health
    Authorities. NIAID will also monitor the collection of essential
    documents from individual CTUs.

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a.  cGCP Training: Provide cGCP training directly or through NIAID
    Contract Research Organizations (CROs) (see Appendix F).

b.  Biostatistical Support**:** NIAID will provide biostatistical
    support for protocol development and analysis of clinical endpoints
    through CROs (see Appendix F) or through staff of the NIAID
    Biostatistics Branch. Independent of the government, the Network
    will be responsible for the statistical analyses outlined in Section
    VI of the Statement of Work: "Bioinformatics, Data Collection, and
    Validation."

c.  Case Report Forms**:** NIAID will support development of Case Report
    Forms CRFs) for the collection of clinical data either directly or
    through NIAID CROs.

d.  Medical Monitoring: NIAID staff will serve as medical monitors for
    all Network clinical trials and as liaisons to the relevant NIAID
    Data and Safety Monitoring Boards (DSMBs). DSMB reviews will be held
    at regular intervals as described in each protocol and/or at the
    discretion of the primary Medical Officer from NIAID. The DSMBs are
    advisory to NIAID and are managed by NIAID.

e.  Project Management Support**:** NIAID will provide the following
    project management support services:

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i.  Site Management: Assess individual site competence and direct site
    training and auditing.

ii. Timelines and Milestones**:** Review study progress timelines to
    ensure adherence to established timelines.

iii. Clinical Trial Oversight**:** Directly oversee Network activities,
     or do so through NIAID CROs (see Appendix F), to ensure site
     compliance with cGCP and safe clinical trial management.

iv. Study Product Distribution**:** Manage all activities related to
    study product distribution, tracking and retrieval and ensure that
    such activities are in compliance with cGCP and consistent with
    relevant Clinical Trial Agreements, where applicable.

> **PART E: LABORATORIES FOR THE DEVELOPMENT AND VALIDATION OF ASSAYS
> AND THE CONDUCT OF MECHANISTIC STUDIES**

1.  The Technical Proposal must include a plan for establishment and
    management of a consortium of institutions and/or companies capable
    of providing the scientific and technical expertise to design and
    execute mechanistic studies and to develop and validate new/improved
    assays to assess the induction, maintenance, or loss of immune
    tolerance. This plan must include the following:

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a.  Describe the proposed membership of the consortium, criteria for
    selection of member laboratories, and the capabilities of each
    proposed laboratory to include experience in performing laboratory
    assessments in support of clinical studies and performance in
    quality management programs. All work conducted in such laboratories
    shall use or be directly relevant to the determination of tolerance
    in human cells and tissues. Assay development in animal models for
    ultimate application in humans, other than as described in the
    Statement of Work, Section 3, Nonclinical Research and Product
    Development, will not be supported under this contract.

    b.  Describe laboratory services and assays previously or currently
        provided by each proposed laboratory.

    c.  Provide a proposed plan for the management and oversight of the
        laboratories and for the coordination of studies under taken by
        these laboratories. The use of schematics and flow charts to
        delineate responsibilities, communications, and lines of
        reporting authority is highly recommended.

    d.  Describe existing systems or capabilities to design and develop
        systems for shipping, distribution, storage, and processing of
        patient samples. Note that Network capabilities related to
        sample tracking systems should be addressed separately in the
        response to Statement of Work, Section 6: "Bioinformatics, Data
        Collection, and Validation."

    e.  Provide examples of standard operating procedures for quality
        assurance and quality control and document the capabilities of
        the proposed laboratories to meet cGLP or equivalent performance
        standards.

    f.  As required above (Part A, Section 1), the Technical Proposal
        must include a Strategic Plan and Research Agenda that describes
        the mechanistic studies to accompany Network clinical trials.
        Document the Offeror's capacity to address the relevant elements
        of the research agenda and to redirect resources to pursue new
        opportunities as they arise.

> **PART F: BIOINFORMATICS, DATA COLLECTION, AND VALIDATION**

1.  Provide a detailed plan for developing and disseminating
    applications that enable scientists working independently in
    different studies to generate, normalize, archive, and exchange data
    of all types easily and without risk of data corruption.

2.  Provide a detailed plan for establishing a sample tracking and
    inventory system. Describe how bar codes will be used throughout the
    sample processing.

3.  Provide a detailed plan for ongoing analytical support.

4.  Briefly describe how the Network will interact with the
    Bioinformatics Integration Support Contract (BISC) and other support
    contractors in this area.

5.  In order to avoid redundancy and maximize efficiency, it is
    anticipated that the ontology, data models, software and many of the
    analyses tools developed by the BISC project will have general
    applicability to Network activities and will be utilized by the
    Network when appropriate.

> **PART G: COLLABORATION WITH OTHER CLINICAL RESEARCH PROGRAMS AND
> ORGANIZATIONS**
>
> To date, the Network has collaborated with the National Institute of
> Diabetes and Digestive Diseases and Kidney Disorders (NIDDK)-led Type
> 1 Diabetes TrialNet; the range of collaborative activities includes
> co-development and implementation of clinical trial protocols,
> separate conduct of mechanistic studies on behalf of the Type 1
> Diabetes TrialNet, and utilization of a common DSMB. Offerors should
> include plans for continuation of these activities and future
> collaborations involving other NIAID-sponsored networks, potentially
> including: the Autoimmunity Centers of Excellence (ACEs), the Clinical
> Trials in Organ Transplantation (CTOT), and the Environmental
> Determinants of Diabetes in the Young (TEDDY). Brief descriptions of
> these research programs are provided in Appendix F "NIH- Sponsored
> Clinical Research Programs."
>
> The Technical Proposal should briefly describe any proposed
> collaborations beyond those mentioned immediately above. In preparing
> the Technical Proposal, Offerors should assume that collaborations
> with pharmaceutical and biotechnology industry partners will be
> governed by Clinical Trial Agreements or Cooperative Research and
> Development Agreements to be negotiated between the industry partner
> and the NIAID. Where appropriate, the Network will be included as a
> third party to such agreements.
>
> **PART H: TRANSITION PLANS**

1.  **Initial Transition**

> Describe the proposed plan for the initial transition of ongoing
> clinical and mechanistic studies from the incumbent contractor,
> including the orderly receipt of work in progress from the incumbent
> contractor. At a minimum, the initial transition plan must include the
> proposed timeframe to complete all transition activities and a
> description of the staff required to execute an orderly and efficient
> transition. The transition plan also shall include the items described
> below and any additional information the Contractor deems necessary
> for an orderly transition.

a.  Describe how the Offeror proposes to communicate with and receive
    from the incumbent contractor information regarding work in
    progress;

b.  Propose detailed plans for the continuation and completion of all
    work in progress and for the movement of other contract-generated
    resources, including equipment, scientific and clinical data,
    patient samples, etc.

c.  Identify the staff assigned to the initial transition and describe
    their roles, responsibilities, and qualifications; and

d.  Include a plan to establish subcontracts, consulting agreements,
    purchase orders/agreements, confidentiality/intellectual property
    agreements, and leasing agreements in an expedited manner to enable
    the continuation and/or completion of clinical trials and other
    research activities without interruptions or delays.

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2.  **Final Transition**

> Describe how activities being carried out under this contract will be
> transitioned to the Government or to a successor contractor. Include
> timelines for the initiation and completion of all transition
> activities outlined in the Statement of Work and a description of the
> staffing requirements to execute an orderly and efficient transition.
>
> In the event the contract awarded under this solicitation is
> recompeted, describe how ongoing activities will be transitioned to a
> new contractor, including movement of all Government-furnished
> property to the site of the new contractor by the completion date of
> this contract. It is estimated this shall take no longer than 6
> calendar months.
>
> PART I: EXPANSION OPTIONS
>
> The Government anticipates a need for additional nonclinical research
> and product development, clinical trials, mechanistic studies, and
> bioinformatics support as outlined in this Statement of Work. Such an
> increase in the Contractor's activities may be required, at the
> discretion of the NIAID, through exercise of an Option for additional
> tasks under the terms of this contract. Up to ten (10) options may be
> exercised in any contract year.
>
> The Offeror shall provide a description of plans to implement the
> options based on the assumptions below. The description shall describe
> the Network capabilities required to implement and direct the
> expansion and timelines for all tasks required to carry out such an
> expansion.

1.  Production of two (2) additional lots of cGMP manufactured study
    product. The amount of finished product must be sufficient to
    complete the nonclinical and clinical studies outlined in (2)
    and (3) below.

2.  Two (2) 28-day toxicity studies conducted in two (2) species per
    study.

3.  One (1) additional four-year, Phase II clinical trial of eighty (80)
    subjects.

4.  Two (2) additional one-year, new mechanistic studies.

5.  One (1) additional Senior Bioinformatician at 25% effort and one (1)
    additional Software Engineer at 25% effort.

SECTION 2: PROJECT MANAGEMENT

1.  Describe how the project will be staffed, organized and managed.
    Describe in detail the responsibilities and level of effort for all
    proposed personnel who will be assigned to the contract, and an
    administrative framework indicating clear lines of authority and
    responsibility for the personnel. In addition, provide a description
    of proposed project management controls to keep multiple tasks on
    time and on budget. Outline how the Principal Investigator will
    communicate and interact with the NIAID Contracting Officer and the
    NIAID Project Officer and how the Principal Investigator will
    communicate, monitor, and manage the project both internally and
    externally (at subcontractor sites and facilities).

2.  Subcontract Acquisition and Management:

    a.  Provide a proposed plan for subcontract acquisition and
        management, including soliciting, evaluating, negotiating,
        awarding, and post-award administration in accordance with the
        requirements established by Federal contracting regulations.

    b.  Describe proposed plans and methods to assess subcontractor
        performance, identify performance problems and approaches for
        their remediation, including noncompliance with subcontract
        terms and conditions, and implement corrective actions when
        necessary.

SECTION 3: SCIENTIFIC, TECHNICAL AND ADMINISTRATIVE PERSONNEL

> The Technical Proposal should include all information relevant to
> document organizational and individual experience and management
> capabilities necessary for the successful completion of all contract
> requirements. Proposals should include a Staffing Plan for the conduct
> of the Statement of Work, including role descriptions and level of
> effort of key scientific, technical and administrative personnel.
> Summarize the experience, expertise, and other relevant qualifications
> of each CTU Principal Investigator and key staff.

1.  Principal Investigator (PI): Describe the PI's experience, training,
    expertise, and qualifications, as well as proposed percentage of
    effort. Describe the PI's experience in leading and directing
    projects of similar complexity to this contract either directly or
    indirectly through subcontracts. This includes: scientific and
    technical expertise in scientific disciplines relevant to tolerance
    induction; the evaluation of tolerance induction therapies in humans
    for transplantation, autoimmune disorders, and asthma and allergic
    diseases; the development and conduct of immune/surrogate markers
    and studies of underlying mechanisms; the solicitation and
    evaluation of the technical merit of subcontract proposals; and the
    capacity to monitor progress, assess performance, identify
    performance problems and implement corrective actions. Limit the
    PI's CV to 2-3 pages and provide selected references for
    publications relevant to the scope of requirements for the contract.

> 2\. Other Key Scientific and Technical Personnel: Describe the
> experience, training, expertise and qualifications, as well as the
> percentage of effort for all proposed key scientific and technical
> personnel, including subcontractors. Include experience in designing
> and conducting projects of similar complexity. Limit CVs to 2-3 pages
> and provide [selected]{.underline} references for publications
> relevant to the scope of requirements for the contract. Also provide
> information on ongoing support for training and professional
> development of key scientific and technical staff to maintain
> appropriate qualifications.
>
> 3\. Other Personnel: Describe the responsibilities and document the
> relevant experience, training and expertise of other personnel
> proposed to carry out contract requirements, including all proposed
> subcontractors. In particular, Offerors should document their
> abilities to address the extensive and complex range of subcontracting
> activities required throughout the duration of the contract,
> including:

a.  The ability to solicit, negotiate, and execute a large number of
    subcontracts supporting a range of clinical, nonclinical, and
    mechanistic activities.

b.  The ability to oversee and manage the administrative and operational
    activities of subcontractors on a daily basis, including financial
    monitoring, tracking of deliverables and reporting requirements,
    subcontractor performance, and achievement of milestones.

c.  Experience with identification and remediation of subcontractor
    performance deficiencies or noncompliance with subcontract terms and
    conditions.

d.  Ability and availability of key staff to communicate closely with
    NIAID Project Officer and the NIAID Contracting Officer.

```{=html}
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```
4.  Confidentiality of Data and Intellectual Property

> Describe how the Contractor will safeguard confidentiality and
> intellectual property rights of the data and materials provided by
> third parties or the U.S. Government, as well as data generated during
> the contract.

SECTION 4: FACILITIES AND OTHER RESOURCES

> The Technical Proposal should document the availability and adequacy
> of facilities, equipment, space and other resources necessary to carry
> out the contract requirements, including:

1.  Location and features of facilities (lease or ownership information
    should be provided);

2.  Identification and description of ALL support resources (including
    IT systems) which will be required to effectively carry out contract
    requirements.

**SECTION 5: TABLE OF CONTENTS FOR DOCUMENTATION REQUIRED UNDER SECTION
L OF THE SOLICITATION**

I.  **Human Subjects**

> Section L of the RFP specifies the minimum documentation requirements
> for Human Subjects use. All related documentation should be included
> in the proposal in a clearly marked section. The Technical proposal
> should document all information necessary to evaluate Human Subject
> use. The following information is essential:

a.  Human Subjects: Include plans for compliance with applicable
    domestic and international regulations on the use of human subjects
    (e.g., IRB submission and approval plans, consent procedures, etc.).

b.  Health Insurance Portability & Accountability Act (HIPAA). Include
    plans for compliance with HIPAA.

```{=html}
<!-- -->
```
II. **Privacy Act**

> Section L of the RFP specifies the minimum documentation requirements
> for Privacy Act compliance. All related documentation should be
> included in the proposal in a clearly marked section.

III. **Animal Welfare**

> Section L of the RFP specifies the minimum documentation requirements
> for Animal Welfare compliance. All related documentation should be
> included in the proposal in a clearly marked section. The Technical
> proposal should document all information necessary to evaluate Animal
> welfare issues.

IV. **Data Sharing Plan**

> Section L of the RFP specifies the minimum documentation requirements
> for Data Sharing. All related documentation should be included in the
> proposal in a clearly marked section. The Technical Proposal should
> include a plan for Data Sharing as required by the RFP.

V.  **Plan for Sharing Model Organisms**

> Section L of the RFP specifies the minimum documentation requirements
> for Model Organism sharing. All related documentation should be
> included in the proposal in a clearly marked section. The Technical
> Proposal should include a plan for sharing Model Organisms as required
> by the RFP.

VI. **Biohazard Safety**

> The Technical Proposal should include a plan for biohazard security
> requirements.

VII. **IT Systems Security.**

> The Technical Proposal should include a plan for IT Systems security.

VIII. **Fetal Tissue or DNA Molecule Research**

> Section L of the RFP specifies the minimum documentation requirements
> for Fetal Tissue or DNA Molecule research. All related documentation
> should be included in the proposal in a clearly marked section.

IX. **Project Objectives NIH 1688-1**

The offeror shall insert a completed NIH Form 1688-1, Project Objective,
as provided in Section J, Attachments, behind the Title Page of each
copy of the proposal, along with the "Government Notice for Handling
Proposals." The NIH Form 1688-1 is to be completed as follows:

For an **Institution of Higher Education:** The form [MUST]{.underline}
be completed in its entirety.

For **OTHER** than an Institution of Higher Education: The starred items
(Department, Service, Laboratory or Equivalent, and Major Subdivision)
should be left blank.

> []{#APPENDIXB .anchor}**Collaborative Network for Clinical Research on
> Immune Tolerance**

**RFP-NIH-NIAID-DAIT-07-33**

**[APPENDIX B]{.underline}** **- ADDITIONAL BUSINESS PROPOSAL
INSTRUCTIONS**

**(UNIFORM COST ASSUMPTIONS)**

+-----------------------------------------------------------------------+
| **In addition to the format requirements for the business proposal    |
| that are contained in Section L of the solicitation, the information  |
| provided in this appendix is intended to provide uniform cost         |
| assumptions and business clarifications.**                            |
|                                                                       |
| Offerors are advised to give careful consideration to the statement   |
| of work, all reference material provided as appendices and            |
| attachments, and the technical evaluation criteria, and, the RFP as a |
| whole, in the development of their proposal. The information          |
| requested in these instructions should be used as a guide for the     |
| development and formatting of the business proposal. Offerors should  |
| consider and include the information requested in this appendix.      |
+-----------------------------------------------------------------------+

**APPENDIX B -- ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS**

**[BUSINESS PROPOSAL -- TABLE OF CONTENTS]{.underline}**

**SECTION 1 --** **PROPOSAL COVERSHEET**

**SECTION 2 --** **COST OR PRICE SUPPORT**

Section L of the RFP specifies the minimum documentation requirements
for cost data and all cost related support. All related documentation
should be included in the proposal in a clearly marked section.

**SECTION 3 --** **UNIFORM COST ASSUMPTIONS**

1.  **Meetings and Travel**

    a.  Offerors should assume three (3) 2 -day Steering Committee
        meetings per year, one located on the east coast, one located on
        the west coast and one in the Midwest for no more than
        forty-five (45) participants.

    b.  Offerors should assume three (3) 2-day Network Executive
        Committee meetings per year, one located on the east coast, one
        located on the west coast and one located in the Midwest for no
        more than six (6) participants.

    c.  Offerors should assume four (4) 2-day clinical trial
        Investigator Kick-off Meetings per year, two located on the east
        coast, one located on the west coast and one located in the
        Midwest for no more than twenty (20) participants.

    d.  Offerors should assume seven (7) 1-day face-to-face protocol
        development meetings per year, two on the east coast, two on the
        west coast and three in the Midwest for no more than twenty (20)
        participants.

    e.  Offerors should assume an additional two (2) 2-day meetings per
        year, conducted on an as needed basis, one on the east coast and
        one on the west coast for no more than four (4) participants.

    f.  Offerors should assume thirty (30) 2-day trips for non-local
        professional development per year.

2.  **Clinical Trials**

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```
a.  Offerors should assume that six (6) clinical trials in autoimmunity,
    eight (8) clinical trials in transplantation, and three (3) clinical
    trials in asthma/allergy will be in progress at the time of award
    and will be transitioned to the successful Offeror.

b.  Offerors should assume that approximately six (6) new clinical
    trials at five (5) clinical trial sites will be approved for
    implementation in each year of the contract. Assume that three (3)
    clinical trials will be two-year, Phase II studies with an average
    of 20 study participants each. Additionally, assume that three (3)
    clinical trials will be multi-center, Phase II/III studies with an
    average of 150 study participants each.

c.  Offerors should assume that agents, molecules and reagents for the
    clinical trials conducted by the Network will be provided at no cost
    to the Contractor through Clinical Trial Agreements or Cooperative
    Research and Development Agreements (CRADAs) established between
    NIAID and partners in the pharmaceutical or biotechnology
    industries. For certain high priority trials, where no commercial
    partnership can be formed, the Network may elect to purchase study
    products. However, Business Proposals should **NOT** include any
    costs associated with the purchase of such investigational agents.

d.  Offerors should **NOT** include any costs associated with the
    purchase of investigational agents. Note, however, that costs for
    the manufacture or preclinical evaluation of study products under
    the Statement of Work, Section III, should be included in the
    Business Proposal (see specific uniform assumptions in item 3.
    below).

```{=html}
<!-- -->
```
3.  **Nonclinical Research and Product Development**

    a.  Offerors should assume two (2) single dose toxicity studies (2
        species/study- Rodent and Non-rodent species) per year.

    b.  Offerors should assume two (2) 28-day toxicity studies (2
        species/study- Rodent and Non-rodent species) per year.

    c.  Offerors should assume two (2) pharmacokinetic studies (2
        species/study- Rodent and Non-rodent species) per year.

    d.  Offerors should assume two (2) safety pharmacology studies per
        year.

    e.  Offerors should assume they will be responsible for two (2)
        batches of cGMP manufacture of drug product for Nonclinical and
        Clinical Studies per year.

4.  **Mechanistic Studies**

    a.  Offerors should assume that there will be six (6) new
        mechanistic studies sponsored by the Network each year, and
        four (4) additional mechanistic studies incorporated into
        non-Network clinical trials.

    b.  Offerors should assume that there will be two (2)
        non-Network-sponsored mechanistic studies each year, and that
        these will be cost-neutral.

5.  **Information Technology Hardware and Software**

    a.  Offerors should assume upgrade of a percentage of existing
        hardware and software in years three (3) and five (5) of the
        contract.

**SECTION 4 --** **OPTIONAL ACTIVITIES (If and to the extent
exercised)**

> Offerors submitting a proposal under this solicitation must prepare a
> Technical Proposal and Business Proposal for the entire Statement of
> Work including options.   Proposals for the basic effort alone, or the
> options alone will not be accepted for review or considered for
> award. 
>
> Options will be included in the contract as the government anticipates
> a need for additional nonclinical research and product development,
> clinical trials, mechanistic studies, and bioinformatics support.
> Exercise of the options shall be solely at the discretion of the
> Government and will be based on technical merit, need, and the
> availability of funds during the seven-year period of performance.

The Offeror shall price each option separately based on the following
assumptions:

1.  Production of two (2) additional lots of cGMP manufactured study
    product. The amount of finished product must be sufficient to
    complete the nonclinical and clinical studies outlined in (2)
    and (3) below.

2.  Two (2) 28-day toxicity studies conducted in two (2) species per
    study.

3.  One (1) additional four-year, Phase II clinical trial of eighty (80)
    subjects.

4.  Two (2) additional one-year, new mechanistic studies.

5.  One (1) additional Senior Bioinformatician at 25% effort and one (1)
    additional Software Engineer at 25% effort.

**SECTION 5 - BUDGET INSTRUCTIONS TO OFFEROR**

1.  Offerors shall provide a one-page budget summary for all years of
    the contract for:

    a.  Network scientific, technical and administrative infrastructure
        alone including all committees, meetings, teleconferences,
        dedicated CTUs, laboratories, etc. (no costs for studies)

    b.  Clinical trials in transplantation

    c.  Clinical trials in asthma and allergic diseases

    d.  Clinical trials in autoimmune diseases

    e.  Mechanistic studies and biomarker/surrogate marker development,
        including laboratories

    f.  Nonclinical research and product development

    g.  Bioinformatics and data validation/analysis

2.  Offerors shall provide individual budget breakdowns for each of the
    items listed above.

3.  Offerors shall provide a separate one-page summary for each of the
    five options.

**SECTION 6 - SECURE ONE HHS PERSONNEL REQUIREMENTS**

### [Background Investigations]{.underline}: All contractor personnel designated with position-sensitivity levels that are commensurate with the responsibilities and risks associated with the position require suitability background investigations to be completed and favorably adjudicated for personnel assigned to these positions prior to allowing access to sensitive Departmental systems and networks.

### [Disciplinary Action]{.underline}: Disciplinary or adverse actions against contractors who violate the *HHS Information Security Program Policy*, *HHS Information Security Program Rules of Behavior*, and system-specific rules of behavior will be enforced throughout the life of the contract.

### [Personnel Separation]{.underline}**:** Upon contract or contractor employee termination, or other departure, all access and privileges to Departmental systems, networks, and facilities will be immediately revoked. 

**SECTION 7 -- SUBCONTRACTING**

**1.** Offerors should demonstrate a thorough understanding of the
subcontracting process, procedures, rules and regulations as set forth
in the Federal Acquisition Regulations, FAR Part 44 and FAR Clause
52.244-2, "subcontracts"; The Contractor's Request to Subcontract
Checklist is provided as [Attachment 37](#subKchecklist) as a guide.

**SECTION 8 - TABLE OF CONTENTS FOR DOCUMENTATION REQUIRED UNDER SECTION
L OF THE SOLICITATION**

I.  **Small Business Subcontracting Plan**

> Section L of the RFP specifies the minimum documentation requirements
> for completing a subcontracting plan. This plan should be turned in
> with the original proposal. All related documentation should be
> included in the proposal in a clearly marked section.

II. **Extent of Small Disadvantaged Business Participation**

> Section L of the RFP specifies the minimum documentation requirements
> for small disadvantaged business utilization. This information should
> be turned in with the original proposal. All related documentation
> should be included in the proposal in a clearly marked section.

III. **Past Performance Data, including references**

> Section L of the RFP specifies the minimum documentation requirements
> for providing past performance information. This information should be
> turned in with the original proposal. All related documentation should
> be included in the proposal in a clearly marked section.

**GOVERNMENT PROPERTY - SCHEDULE**[]{#govtproperty .anchor}

  ------------------- ------------------ ------------ ------------------ -------------
  **Description**     **Manufacturer**   **Item       **Serial Number**  **Total
                                         number**                        Cost**

  Computer            Dell               L-C610, P3   TW-06E929-         \$ 2,382

  Computer            Dell               L-C610, P3   TW-06E929-         \$ 2,493

  Laserjet Printer    HP                 4100N        SUSJNF20444        \$ 1,594

  Computer            Dell               GX400        2J98711            \$ 2,441

  Computer            Dell               GX400        BCDG911            \$ 1,529

  Laptop              Sony               R505, P3     S0131023061        \$ 2,290

  Laserjet Printer    HP                 4100TN       USJNF35831         \$ 2,142

  Computer            Dell               PC-800       C8ZNV11            \$ 1,723

  Computer            Dell               PC-800       2J98711            \$ 1,793

  Affymetrix          LIMS               900253       900253             \$ 131,752

  Server              Compaq             142673-B22   D244JQ31D006       \$ 8,224

  Server              Compaq             33SCSI       8F2ADDC8Y0HS       \$ 1,362

  Server              Compaq             Compaq       E84-00125-ZZ       \$ 3,078

  Server              Compaq             Compaq       M02-000222-ZZ      \$ 1,200

  Server              Compaq                          257913-B21         \$ 3,647

  Server              Compaq             DL380        D246KJN2D006       \$ 17,780

  Server              Compaq             COM 36GB     8H2AFFV6HoTN       \$ 3,696

  Server              Compaq             HPL HD                          \$ 3,562

  Server              Compaq             R3000        TU433A0023         \$ 1,224

  Server              Compaq             COM 36GB     8H2AFFV6H0K3       \$ 1,584

  Desktop computer    Dell               OptiPlex     F5PLG21            \$ 2,194

  Desktop computer    Dell               OptiPlex     JCDNL21            \$ 1,856

  Desktop computer    Dell               OptiPlex     2MSZL21            \$ 1,626

  Desktop computer    Dell               OptiPlex     FHN8B21            \$ 1,613

  Laptop computer     Dell               C640         BL68K21            \$ 2,536

  Laptop computer     Dell               C640         32FF521            \$ 2,883

  Laptop computer     Dell               C640         B7YB821            \$ 2,153

  Laptop computer     Dell               C640         JHT6221            \$ 1,731

  Desktop             Dell               C640         GKJGC21            \$ 1,915

  Laptop computer     Dell               C640         F6YTJ21            \$ 2,480

  Laptop computer     Dell               C640         J5YTJ21            \$ 2,659

  Laptop Computer     Dell               C640         43N1B21            \$ 2,369

  Laptop Computer     Dell               C640         65X0B21            \$ 2,593

  Laptop computer     Dell               C640         1M68K21            \$ 2,563

  Laptop computer     Dell               C640         18BG221            \$ 2,452

  Desktop             Dell               8200         5JD811             \$ 1,793

  Laptop computer     Dell               C640         84M5M21            \$ 2,620

  Desktop             Dell               OptiPlex     64J9R21            \$ 1,546

  Desktop             Dell               OptiPlex     J4J9R21            \$ 1,590

  Desktop             Dell               OptiPlex     D5J9R21            \$ 1,546

  Laptop computer     Dell               C640         5SF0V21            \$ 2,600

  Laptop computer     Dell               C640         5R26Y11            \$ 2,624

  Laptop computer     Dell               C640         FQ26Y11            \$ 2,624

  Laptop computer     Dell               PP03L        2D166A01           \$ 2,421

  Laptop computer     Dell               C640         5H4H521            \$ 2,883

  Laptop computer     Dell               C640         63N1B21            \$ 2,306

  Laptop Computer     Dell               Latitude     6FN6M831           \$ 2,684
                                         D600                            

  **Description**     **Manufacturer**   **Item       **Serial Number**  **Total
                                         number**                        Cost**

  DNA Engine          MJ Research        EN 021789    AL062882           \$ 9,825

  Desktop Computer    Dell               Precision    CK45831            \$ 2,540

  Laptop Computer     Dell               Latitude     JTFX331            \$ 2,575

  Minolta Copier      Minolta            D1351        4026311-31009000   \$ 14,054

  Desktop Computer    Dell               OptiPlex     2LQ8831            \$ 1,621

  Laptop Computer     Dell               Latitude     39BCH31            \$ 2,677

  Laptop Computer     Dell               Latitude 600 2HQHG31            \$ 2,639

  Bioanalyzer System  Dell               HP 2100      DE24802455         \$ 20,253

  Dell Powevault      Dell               221S Tower   9PJV231            \$ 12,034

  Affymetrix          GC 3000            GC 3000      FS0779             \$ 154,613

  Fisher Scientific   Centrifuge         H2380914     N/A                \$ 5,588

  Laptop Computer     Dell               Latitude     4P77241            \$ 2,718
                                         X300                            

  Desktop Computer    Dell               Precision    FV79441            \$ 2,787
                                         360                             

  Laptop Computer     Dell               Latitude     1JFH941            \$ 2,592
                                         D600                            

  Laptop Computer     Dell               Latitude     4FW7941            \$ 2,694
                                         D600                            

  Laptop Computer     Dell               Latitude     783Z541            \$ 2,257
                                         D600                            

  Minolta Copier      Minolta            DI 351       31729347           \$ 9,025

  Minolta Copier      Minolta            DI 351       22003226           \$ 10,279

  Minolta Copier      Minolta            D1351        4026311-31009000   \$ 14,054

  Minolta Copier      Minolta            PS3          4397311-3001603    \$ 18,110

  Laser Jet Printer   Hewlett Packard    4650         JPDAC03123         \$ 2,271

  Laser Jet Printer   Hewlett Packard    4650         JPDAC03124         \$ 2,271

  Dell Precision      Dell               650 Tower    JMH7Y41            \$ 8,637
  Workstation                                                            

  Inspirion laptop    Dell               X300         JSW0X41            \$ 3,895

  Dell Laptop         Dell               D600         7VB5351            \$ 2,251

  Dell Laptop         Dell               D600         2QB5351            \$ 2,251

  Dell laptop         Dell               D600         2TFIJ31            \$ 2,797

  Dell laptop         Dell               D600         HSB5351            \$ 2,251

  Dell Laptop         Dell               D600         6WB5351            \$ 2,251

  Dell laptop         Dell               D600         9HKBP41            \$ 3,379

  Dell laptop         Dell               D600         H2Y1G41            \$ 2,780

  LCD Projector       Dell               3200MP       25B2X21            \$ 1,797

  Power Edge          Dell               Dell 6600    COMY441            \$ 21,086

  Dell laptop         Dell               D600         D6JQB51            \$ 2,692

  Dell laptop         Dell               D600         8X8FC51            \$ 2,732

  Dell laptop         Dell               D600         G8DGC51            \$ 2,732

  Latitude            Dell               D800         BF7PX41            \$ 3,816

  Laptop Computer     Dell               Latitude     B7XGP51            \$ 2,713
                                         D600                            

  Laptop Computer     Dell               Latitude     11PTF51            \$ 3,155
                                         D600                            

  Laptop Computer     Dell               Latitude     5WVXM51            \$ 2,763
                                         D600                            

  Laptop Computer     Dell               Latitude     HXVXM51            \$ 2,713
                                         X300                            

  Laptop Computer     Dell               Latitude     6HLGZ51            \$ 2,555
                                         X300                            

  Laptop Computer     Dell               Latitude     DPNWT51            \$ 2,788
                                         X300                            

  OptiPlex SX270      Dell               SX270        2CP9G41            \$ 1,720

  Video Conferencing  Dell               C640         510029             \$ 9,487

  Laptop Computer     Dell               Latitude     C37Q461            \$ 2,929
                                         D600                            

  Laptop Computer     Dell               Latitude     D508J61            \$ 2,710
                                         D610                            

  Laptop Computer     Dell               Latitude     9WCVP61            \$ 2,655
                                         D610                            

  Laptop Computer     Dell               Latitude     DHJQV61            \$ 2,941
                                         D610                            

                                                                         

  **Description**     **Manufacturer**   **Item       **Serial Number**  **Total
                                         number**                        Cost**

  Video Conferencing  VSGI                            19737              \$ 49,645

  Laptop Computer     Dell               Latitude     HQ6JL71            \$ 1,657
                                         D610                            

  Gene Spring                                                            \$ 84,808
  Software                                                               

  Laptop Computer     Dell               Latitude     J1ZFL71            \$ 1,657
                                         D610                            

  Laptop Computer     Dell               Latitude     FM6JL71            \$ 1,657
                                         D610                            

  Laptop Computer     Dell               Latitude     DFZ2P71            \$ 1,793
                                         D610                            

  Beckman Coulter     BCI                                                \$ 112,954

  Server              Hewlett Packard    HP Proliant  H15896200          \$ 22,337

                                                                         

  HP Rack             Hewlett Packard    ML 570G3     USE533C31L         \$ 11,966

                                                                         
  ------------------- ------------------ ------------ ------------------ -------------

**Collaborative Network for Clinical Research on Immune Tolerance**

**RFP-NIH-NIAID-DAIT-07-33**

[]{#AppendixC .anchor}**APPENDIX C**: **Ongoing Immune Tolerance Network
Clinical Trials and Tolerance Assay Studies**

+-------+-----+------------+------+--------+------+-------+-------+
| **I   |     |            |      |        |      |       |       |
| mmune |     |            |      |        |      |       |       |
| Tole  |     |            |      |        |      |       |       |
| rance |     |            |      |        |      |       |       |
| Netw  |     |            |      |        |      |       |       |
| ork** |     |            |      |        |      |       |       |
+=======+=====+============+======+========+======+=======+=======+
|       |     |            |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| *     | *   | **Protocol | **Ta | **Pr   | **S  | **PRO | **    |
| *AREA | *Pr | Name**     | rget | otocol | tudy | TOCOL | Clini |
| of    | oto |            | Enr  | St     | Comp | CHAIR | cal** |
| ST    | col |            | ollm | atus** | leti | (S)** |       |
| UDY** | \   |            | ent/ | (P     | on** |       | **T   |
|       | #** |            | \#   | SD=Pro |      |       | rials |
|       |     |            | of   | jected |      |       | \#**  |
|       |     |            | sit  | Start  |      |       |       |
|       |     |            | es** | Date)  |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| ** ** |     |            |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| **ITN |     |            |      |        |      |       |       |
| CLI   |     |            |      |        |      |       |       |
| NICAL |     |            |      |        |      |       |       |
|   **  |     |            |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| A     | IT  | AIC in     | 60/  | Pr     | \~   | David |       |
| utoim | N03 | Ragweed    | 3    | otocol | 2010 | B     |       |
| mune: | 1AD | Induced    |      | Devel  |      | roide |       |
| Al    |     | Asthma     |      | opment |      |       |       |
| lergy |     |            |      | PSD:   |      |       |       |
|       |     |            |      | 2005   |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| A     | IT  | A Trial of | 440/ | Pr     | \~   | G     |       |
| utoim | N03 | Oral       | 2    | otocol | 2011 | ideon |       |
| mune: | 2AD | Tolerance  |      | Devel  |      | Lack, |       |
| Al    |     | Induction  |      | opment |      | MD    |       |
| lergy |     | for        |      | PSD:   |      |       |       |
|       |     | Prevention |      | 2006   |      |       |       |
|       |     | of Peanut  |      |        |      |       |       |
|       |     | Allergy    |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| A     | IT  | P          | 200/ | Pr     | \~   | Pa    |       |
| utoim | N02 | rophylaxis | 5    | otocol | 2010 | trick |       |
| mune: | 5AD | of Atopy   |      | Devel  |      | Holt, |       |
| A     |     | and Asthma |      | opment |      | DSC   |       |
| sthma |     | in         |      | PSD:   |      |       |       |
|       |     | Children   |      | 2006   |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| A     | IT  | New Phase  | 81/  | Active | \~   | Kevan | N     |
| utoim | N02 | II         | 6    | Start  | 2009 | He    | CT001 |
| mune: | 7AI | Multiple   |      | Date:  |      | rold, | 29259 |
| Dia   |     | Dose       |      | 2005   |      | MD    |       |
| betes |     | Treatment  |      |        |      |       |       |
|       |     | of Type 1  |      |        |      |       |       |
|       |     | Diabetes   |      |        |      |       |       |
|       |     | Mellitus   |      |        |      |       |       |
|       |     | with       |      |        |      |       |       |
|       |     | hOKT3γ1    |      |        |      |       |       |
|       |     | (Ala-Ala)  |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| A     | IT  | A Pilot    | 10/  | Pr     | \~   | Alex  |       |
| utoim | N01 | Study to   | 1    | otocol | 2009 | Ra    |       |
| mune: | 8AI | Evaluate   |      | Devel  |      | binov |       |
| Dia   |     | the Safety |      | opment |      | itch, |       |
| betes |     | of         |      | PSD:   |      | MD    |       |
|       |     | Int        |      | 2006   |      |       |       |
|       |     | erleukin-2 |      |        |      |       |       |
|       |     | (IL-2) and |      |        |      |       |       |
|       |     | Sirolimus  |      |        |      |       |       |
|       |     | (          |      |        |      |       |       |
|       |     | Rapamycin) |      |        |      |       |       |
|       |     | C          |      |        |      |       |       |
|       |     | ombination |      |        |      |       |       |
|       |     | Therapy In |      |        |      |       |       |
|       |     | Re         |      |        |      |       |       |
|       |     | cent-Onset |      |        |      |       |       |
|       |     | Type 1     |      |        |      |       |       |
|       |     | Diabetes   |      |        |      |       |       |
|       |     | Mellitus   |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| A     | IT  | Thy        | 78/  | Pr     | \~   | St    |       |
| utoim | N02 | moglobulin | 6    | otocol | 2009 | ephen |       |
| mune: | 8AI | for new    |      | Devel  |      | Git   |       |
| Dia   |     | onset T1DM |      | opment |      | elman |       |
| betes |     |            |      | PSD:   |      |       |       |
|       |     |            |      | 2005   |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| A     | IT  | Treatment  | 24/  | Active | \~   | Betty | N     |
| utoim | N00 | of         | 4    | Start  | 2    | Dia   | CT000 |
| mune: | 2AI | Systemic   |      | Date:  | 006; | mond, | 94380 |
| Rh    |     | Lupus      |      | 2004   | foll | MD;   |       |
| eumat |     | Ery        |      |        | owed | David |       |
| ology |     | thematosus |      |        | by a | W     |       |
|       |     | with       |      |        | P    | ofsy, |       |
|       |     | CTLA-41g   |      |        | hase | MD    |       |
|       |     | Plus       |      |        | II   |       |       |
|       |     | Cycloph    |      |        | t    |       |       |
|       |     | osphamide: |      |        | rial |       |       |
|       |     | A Phase II |      |        |      |       |       |
|       |     | Study      |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| A     | IT  | Rituximab  | 200/ | Active | \~   | John  | N     |
| utoim | N02 | Therapy    | 9    | Start  | 2009 | S     | CT001 |
| mune: | 1AI | for the    |      | Date:  |      | tone, | 04299 |
| Rh    |     | Induction  |      | 2004   |      | MD;\  |       |
| eumat |     | of         |      |        |      | U     |       |
| ology |     | Remission  |      |        |      | lrich |       |
|       |     | and        |      |        |      | Sp    |       |
|       |     | Tolerance  |      |        |      | ecks, |       |
|       |     | in         |      |        |      | MD    |       |
|       |     | ANCA-      |      |        |      |       |       |
|       |     | Associated |      |        |      |       |       |
|       |     | Vasculitis |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| A     | IT  | A          | 152/ | Active | \~   | Scott | N     |
| utoim | N02 | R          | 14   | Start  | 2010 | Za    | CT000 |
| mune: | 0AI | andomized, |      | Date:  |      | mvil, | 94172 |
| Mul   |     | Dou        |      | 2005   |      | MD    |       |
| tiple |     | ble-Blind, |      |        |      |       |       |
| Scle  |     | Placebo-C  |      |        |      |       |       |
| rosis |     | ontrolled, |      |        |      |       |       |
|       |     | Mu         |      |        |      |       |       |
|       |     | lti-Center |      |        |      |       |       |
|       |     | Study to   |      |        |      |       |       |
|       |     | Evaluate   |      |        |      |       |       |
|       |     | the        |      |        |      |       |       |
|       |     | Efficacy   |      |        |      |       |       |
|       |     | and Safety |      |        |      |       |       |
|       |     | of         |      |        |      |       |       |
|       |     | At         |      |        |      |       |       |
|       |     | orvastatin |      |        |      |       |       |
|       |     | in         |      |        |      |       |       |
|       |     | Patients   |      |        |      |       |       |
|       |     | with       |      |        |      |       |       |
|       |     | Clinically |      |        |      |       |       |
|       |     | Isolated   |      |        |      |       |       |
|       |     | Syndrome   |      |        |      |       |       |
|       |     | and High   |      |        |      |       |       |
|       |     | Risk of    |      |        |      |       |       |
|       |     | Conversion |      |        |      |       |       |
|       |     | to         |      |        |      |       |       |
|       |     | Multiple   |      |        |      |       |       |
|       |     | Sclerosis  |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| T     | IT  | Evaluation | 12/  | On     | TBD  | Ber   |       |
| ransp | N01 | of the     | 1    | Hold   |      | nhard |       |
| lant: | 5CT | T          |      |        |      | He    |       |
| Islet |     | olerogenic |      |        |      | ring, |       |
|       |     | Efficacy   |      |        |      | MD    |       |
|       |     | of hOKT3γ1 |      |        |      |       |       |
|       |     | (Ala-Ala)  |      |        |      |       |       |
|       |     | and        |      |        |      |       |       |
|       |     | Sirolimus  |      |        |      |       |       |
|       |     | Imm        |      |        |      |       |       |
|       |     | unotherapy |      |        |      |       |       |
|       |     | in Type I  |      |        |      |       |       |
|       |     | Diabetic   |      |        |      |       |       |
|       |     | Islet      |      |        |      |       |       |
|       |     | Allograft  |      |        |      |       |       |
|       |     | Recipients |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| T     | IT  | The Use of | 10/  | Active | \~   | S     | N     |
| ransp | N01 | C          | 1    | Start  | 2008 | tuart | CT000 |
| lant: | 3ST | ampath-1H, |      | Date:  |      | Knec  | 78559 |
| K     |     | T          |      | 2004   |      | htle, |       |
| idney |     | acrolimus, |      |        |      | MD    |       |
|       |     | and        |      |        |      |       |       |
|       |     | Sirolimus  |      |        |      |       |       |
|       |     | Followed   |      |        |      |       |       |
|       |     | by         |      |        |      |       |       |
|       |     | Sirolimus  |      |        |      |       |       |
|       |     | Withdrawal |      |        |      |       |       |
|       |     | in Renal   |      |        |      |       |       |
|       |     | Transplant |      |        |      |       |       |
|       |     | Patients   |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| T     | IT  | LEA29Y in  | 30/  | Pr     | \~   | F     |       |
| ransp | N02 | an         | 2    | otocol | 2009 | lavio |       |
| lant: | 3ST | Immunos    |      | Devel  |      | Vinc  |       |
| K     |     | uppression |      | opment |      | enti, |       |
| idney |     | Withdrawal |      | PSD:   |      | MD    |       |
|       |     | Regimen in |      | 2005   |      |       |       |
|       |     | Recipients |      |        |      |       |       |
|       |     | of Non-HLA |      |        |      |       |       |
|       |     | Identical  |      |        |      |       |       |
|       |     | Living     |      |        |      |       |       |
|       |     | Donor      |      |        |      |       |       |
|       |     | Renal      |      |        |      |       |       |
|       |     | T          |      |        |      |       |       |
|       |     | ransplants |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| T     | IT  | Combined   | 10/  | Active | \~   | Megan | N     |
| ransp | N00 | H          | 1    | Start  | 2009 | S     | CT000 |
| lant: | 8ST | LA-Matched |      | Date:  |      | ykes, | 62621 |
| Kidne |     | Bone       |      | 2001   |      | MD;\  |       |
| y/BMT |     | Marrow and |      |        |      | A.    |       |
|       |     | Kidney     |      |        |      | Ben   |       |
|       |     | Trans      |      |        |      | edict |       |
|       |     | plantation |      |        |      | Co    |       |
|       |     | for        |      |        |      | simi, |       |
|       |     | Multiple   |      |        |      | MD    |       |
|       |     | Myeloma    |      |        |      |       |       |
|       |     | with Renal |      |        |      |       |       |
|       |     | Failure    |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| T     | IT  | Renal      | 10/  | Active | \~   | David | N     |
| ransp | N01 | Allograft  | 1    | Start  | 2010 | S     | CT000 |
| lant: | 0ST | Tolerance  |      | Date:  |      | achs, | 63817 |
| Kidne |     | Through    |      | 2002   |      | MD;\  |       |
| y/BMT |     | Mixed      |      |        |      | A.    |       |
|       |     | Chimerism  |      |        |      | Ben   |       |
|       |     |            |      |        |      | edict |       |
|       |     |            |      |        |      | Co    |       |
|       |     |            |      |        |      | simi, |       |
|       |     |            |      |        |      | MD    |       |
+-------+-----+------------+------+--------+------+-------+-------+
| T     | IT  | Pilot      | 10/  | Active | \~   | J     |       |
| ransp | N02 | Study      | 1    | Start  | 2009 | oshua |       |
| lant: | 2ST | Using      |      | Date:  |      | Mi    |       |
| K     |     | Donor Stem |      | 2003   |      | ller, |       |
| idney |     | Cells And  |      |        |      | MD    |       |
| /Stem |     | Campath-1H |      |        |      |       |       |
| Cell  |     | To Induce  |      |        |      |       |       |
|       |     | Renal      |      |        |      |       |       |
|       |     | Transplant |      |        |      |       |       |
|       |     | Tolerance  |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| T     | IT  | Immunos    | 211/ | Active | \~   | Ri    | N     |
| ransp | N02 | uppression | 14   | Start  | 2012 | chard | CT001 |
| lant: | 4ST | Withdrawal |      | Date:  |      | Thist | 05235 |
| Liver |     | in Liver   |      | 2004   |      | lethw |       |
|       |     | Transplant |      |        |      | aite, |       |
|       |     | Recipients |      |        |      | MD    |       |
+-------+-----+------------+------+--------+------+-------+-------+
| T     | IT  | IS         | 157/ | Active | \~   | Avi   |       |
| ransp | N03 | Withdrawal | 2    | Start  | 2011 | S     |       |
| lant: | 0ST | in Liver   |      | Date:  |      | haked |       |
| Liver |     | Tx         |      | 2005   |      |       |       |
|       |     | Recipients |      |        |      |       |       |
|       |     | with HCV   |      |        |      |       |       |
|       |     | Infection. |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+
| T     | IT  | IS         | 20/  | Pr     | \~   | Sandy |       |
| ransp | N02 | Withdrawal | 2    | otocol | 2012 | Feng  |       |
| lant: | 9ST | in Stable  |      | Devel  |      |       |       |
| Liver |     | Pediatric  |      | opment |      |       |       |
|       |     | LD Liver   |      | PSD:   |      |       |       |
|       |     | Tx         |      | 2005   |      |       |       |
|       |     | Recipients |      |        |      |       |       |
+-------+-----+------------+------+--------+------+-------+-------+

**Collaborative Network for Clinical Research on Immune Tolerance**

**RFP-NIH-NIAID-DAIT-07-33**

**APPENDIX D - Immune Tolerance Network Core Facilities/Laboratories**

**[DNA-based Assays]{.underline}:**

![](media/image1.png){width="1.0416666666666666e-2in"
height="1.0416666666666666e-2in"}[**HLA-Typing
Core**](http://www.immunetolerance.org/research/core/facilities/HLAtyping.html)\
![](media/image1.png){width="1.0416666666666666e-2in"
height="1.0416666666666666e-2in"} *Director:* Lee Ann Baxter-Lowe,
University of California San Francisco

[**RNA-based Assays** (Gene expression profiling)]{.underline}:

[**High Throughput Real Time PCR
Core**](http://www.immunetolerance.org/research/core/facilities/HT_pcr.html)\
*Director:* Mimi Roque-Biewer, Applied Biosystems

> [**RNA Preparation
> Core**](http://www.immunetolerance.org/research/core/facilities/RNAprep.html)\
> *Directors*: P. Suzanne Hart & Paul Wood, University of Pittsburgh;
>
> McKesson Bioservices, Rockville, MD

**[Protein & Cellular Assays]{.underline}**:

**Enzyme-linked Immunospot (ELISPOT) Assay Core**\
*Directors:* TBD

[**MHC-Peptide Tetramer
Facility**](http://www.immunetolerance.org/research/core/facilities/mhcpeptide.html)

*Directors*: Gerald Nepom, Virginia Mason Research Center, Seattle, WA;

> Jeffrey A. Bluestone, University of California San Francisco, San
> Francisco, CA
>
> [**Type 1 Diabetes Autoantibody
> Facility**](http://www.immunetolerance.org/research/core/facilities/autoantibody.html)*\
> Director*: George Eisenbarth, University of Colorado Health Science
> Center, Denver, CO

**Flow Cytometry Core, United States**

*Director*: Paul Wallace, Roswell Park Cancer Institute

**Flow Cytometry Core, Europe**

*Director:* Peter Trinder, Thymed GmbH, Mainz, Germany

**Alloantibody & Flow Cross-match Core**

*Director*: Robert Bray, Emory University, Atlanta, GA

**IDO Core**

> *Director*: David Munn, Medical College of GA, GA

**AlloELISPOT Core**

*Director:* Peter Heeger, Cleveland Clinic Foundation, Cleveland, OH

**Luminex Core**

*Director:* Ger T. Rijkers, Wilhelmina Children's Hospital, Utrecht,
Netherlands

**Trans-vivo Delayed Type Hypersensitivity Core**

*Director:* Will Burlingham, University of Wisconsin, Madison, WI

**ELISA Core**

*Director: R*obert Hamilton, Johns Hopkins Allergy and Asthma Center,
Baltimore, MD

**[Tissue & Histochemical Assays]{.underline}:**

[**Liver Tissue Analysis
Core**](http://www.immunetolerance.org/research/core/facilities/liver_tissue.html)\
*Director:* Anthony Demetris, University of Pittsburgh

[**Renal Pathology
Core**](http://www.immunetolerance.org/research/core/facilities/kidney_tissue.html)\
*Director*: Robert Colvin, Harvard University

**[Additional Cores]{.underline}:**

> **CMV/EBV Viral Load Core**\
> *Contractors:* ViraCore, Lee\'s Summit, MO

**[Specimen Support]{.underline}:**

> **[Clinical Specimen
> Repository](http://www.immunetolerance.org/research/core/facilities/repository.html)**\
> *Contractors:* McKesson Biosciences, Rockville MD

**[Data Support]{.underline}:**

> [**Bioinformatics/Data Analysis
> Core**](http://www.immunetolerance.org/research/core/facilities/bioinformatics.html)\
> *Director:* Dave Parrish, Immune Tolerance Network
>
> **Collaborative Network for Clinical Research on Immune Tolerance**

**RFP- NIH-NIAID-DAIT-07-33**

[]{#APPENDIXE .anchor}**APPENDIX E: NIAID-Funded Clinical Research
Support Services Contracts**

NIAID/DAIT holds contracts with companies that currently provide and
will continue to provide regulatory, clinical site monitoring, data
management and analysis, and drug distribution support to the Network.
The contractors with whom the successful Offeror is expected to interact
in order to perform functions specified within the Statement of Work are
described below. Notifications will be sent to the successful Offeror of
this competition when awards are made for new or recompeted contracts
that provide support for these Network functions.

**[NIAID/DAIT Regulatory Management Center]{.underline}**

> Social & Scientific Systems, located in Silver Spring, MD, provides
> regulatory support services. They will continue to provide support for
> regulatory and clinical compliance functions and requirements
> associated with Health Authority Applications such as Investigational
> New Drug (IND) Applications and Amendments as described below
> \[<http://www.niaid.nih.gov/contract/archive/rfp0444.pdf>\]:

1.  Technical assistance for regulatory and current Good Clinical
    Practice (cGCP) compliance;

2.  Electronic tracking of IND safety reports;

3.  Electronic clinical site registration system;

4.  General administrative support for regulatory affairs and cGCP
    compliance;

5.  Logistical support for all DAIT-sponsored clinical trials; and

6.  Services to facilitate an orderly transition.

**[NIAID/DAIT Clinical Site Monitoring Group]{.underline}**

> PPD Development, LP located in Wilmington, NC, provides evaluations of
> good clinical research practices, regulatory compliance, accurate
> protocol implementation, international quality assurances, and test
> agent accountability during periodic on-site visits to all DAIT-funded
> clinical trial sites. PPD Development specific responsibilities
> include, but are not limited to, the following
> \[<http://www.niaid.nih.gov/contract/archive/rfp0446.pdf>\]:

1.  Examine source documents to assess accuracy and completeness of
    trial data;

2.  Identify problems with protocol implementation, adherence to GCP and
    all applicable regulatory requirements;

3.  Verify proper storage, dispensing and accountability of
    investigational study products;

4.  Provide training on general protocol conduct, cGCP, quality
    management, and DAIT procedures;

5.  Review internal quality assurance/quality control plans;

6.  Report progress during the contract and file ending reports that are
    comprehensive and specific to the description and time tables set
    forth in the contract; and

7.  Facilitate an orderly transition.

**[NIAID/DAIT Drug Distribution Center]{.underline}**

> EMINENT Services Corporation, located in Frederick, MD, establishes
> and maintains the Clinical Products Distribution Center for the
> purpose of purchasing, dispensing and providing quality control of
> study products for Network clinical trials. Specific responsibilities
> of the Contractor include, but are not limited to, the following:\[
> http://[[www.emiserv.com]{.underline}](http://www.emiserv.com/)\].

1.  Purchasing, receiving, storing, labeling, packaging, shipping and
    distribution of study products;

2.  Inventory control and quality assurance of study supplies for each
    protocol;

3.  Pharmaceutical services to including to written reviews, reports,
    transfers, packaging, storage, dosage, labeling, usage and returns
    of products in conjunction with the NIAID Project Officer's approval
    while establishing a secure clinical web site for clinical site
    pharmacists that supplies protocol-specific information and
    requirements;

4.  Security/safety measures and procedures;

5.  Processing and disposal of returned and unused drug product;

6.  Record maintenance; and

7.  Services to facilitate an orderly transfer of all or part of this
    project to a subsequent contractor or the Federal Government.

**[NIAID/DAIT Coordinating Center for Biostatistics, Data Management and
Pharmaco Vigilance]{.underline}**

> PPD Development, LP, located in Wilmington, NC, provides a resource to
> the Network to assure efficient clinical study design, conduct, safety
> monitoring and data analysis. Responsibilities of the Contractor
> include, but are not limited to, the following
> \[<http://www.niaid.nih.gov/contract/archive/rfp0459.pdf>\]:

1.  Providing statistical leadership and clinical trial design expertise
    for the development of protocols and analysis of study data;

2.  Establishing and administering data collection, management, quality
    assurance and reporting systems;

3.  Establishing and managing a safety reporting center;

4.  Detailed record maintenance and timely reporting;

5.  Collaboration with DAIT and research groups; and

6.  Completion of the final deliverables.

**[NIAID/DAIT Bioinformatics Integration Support Contract
(BISC)]{.underline}**

> Northrop Grumman Information Technology, located in Rockville, MD,
> provides information technology support in the production, analysis,
> archiving, exchange and integration of genomic, proteomic and related
> data to NIAID/DAIT-funded research programs via the Immunology and
> Data Analysis Portal (ImmPort at
> [[http://www.immport.org/index.html]{.underline}](http://www.immport.org/index.html)).
> Specific responsibilities of the Contractor include, but are not
> limited, to the following:

1.  Accelerate a more collaborative and coordinated research environment

2.  Create an integrated database that broadens the usefulness of
    scientific data and advances hypothesis-driven and
    hypothesis-generating research

3.  Integrate relevant data sets from participating laboratories, public
    and government databases, and private data sources

4.  Provide analysis tools to advance immunological research

**Collaborative Network for Clinical Research on Immune Tolerance**

**RFP-NIH-NIAID-DAIT-06-25**

[]{#APPENDIXF .anchor}**Appendix F - Descriptions of NIH-Funded Clinical
Research Programs**

**[The Autoimmune Centers of Excellence (ACEs)]{.underline}**

> Nine Autoimmunity Centers of Excellence (ACEs) conduct collaborative
> basic and clinical research on autoimmune diseases, including
> single-site and multi-site pilot clinical trials of immunomodulatory
> therapies and mechanism-of-action studies. The ACEs support close
> interaction between clinicians and basic researchers, which should
> facilitate the identification of effective tolerance induction and
> immune modulation strategies to treat or prevent disease, and
> accelerate the translation of scientific advances to the clinic.
> Examples of ACEs-supported clinical trials include: anti-CD20 for
> systemic lupus erythematosus; sirolimus for multiple sclerosis; and a
> double-masked study of the combination of copaxone and albuterol
> versus copaxone alone for multiple sclerosis. The ACEs are
> co-sponsored by the NIDDK and the NIH Office of Research on Women's
> Health.

**[The Clinical Trials in Organ Transplantation (CTOT)]{.underline}**

> In FY 2004, NIAID, in collaboration with NIDDK and NHLBI, established
> a clinical consortium to improve the success of organ transplants. The
> goals of the consortium are to identify genetic factors in patients
> that could help doctors predict transplant outcomes as well as
> responses to post-transplant therapy; develop diagnostic tests that
> enable early detection and ongoing monitoring of immune-related
> processes; and test the safety and effectiveness of new, less toxic
> immunosuppressive drugs. The consortium is comprised of three
> institutions: Brigham and Women\'s Hospital, Boston; Cleveland Clinic
> Lerner College of Medicine of Case Western Reserve University; and the
> University of Pennsylvania, Philadelphia.

**[Diabetes TrialNet]{.underline}**

> TrialNet is an international network of investigators, clinical
> centers, and core support facilities. It supports the development and
> implementation of clinical trials of agents to slow the progression of
> type 1 diabetes in new onset patients and to prevent the disease in
> at-risk patients. The network also supports "natural history studies"
> that will provide information on risk factors associated with
> development of type 1 diabetes and that will inform the design of
> future trials. TrialNet is supported by the NIDDK, NIAID, NICHD, and
> JDRF.

**[The Environmental Determinants of Diabetes in the Young
(TEDDY)]{.underline}**

> TEDDY is an international consortium to recruit
> genetically-susceptible newborns for studies that test the role of
> infectious agents, dietary factors, and other environmental conditions
> that may trigger type 1 diabetes. Funded by the NIDDK, NIAID, National
> Institute of Child Health and Human Development (NICHD), National
> Institute of Environmental Health Sciences (NIEHS), CDC, and Juvenile
> Diabetes Research Foundation International (JDRF), this long-term
> project will follow participating individuals through adolescence to
> ascertain the onset of autoimmunity and/or type 1 diabetes.

[]{#APPENDIXG .anchor}**Appendix G: Informational Internet sites for the
Immune Tolerance Network and RFP**:

> Introduction and Background
>
> Immune Tolerance Network website:
> [http://www.immunetolerance.org](http://www.immunetolerance.org/)
>
> NIAID Plan for Research on Immune Tolerance and the Report of the
> NIAID Expert Panel on Immune Tolerance:
> <http://www.niaid.nih.gov/research/publications.htm>
>
> Recommendations of the NIAID Expert Panel on Ethical Issues in
> Clinical Trials of Transplant Tolerance:
> <http://www.niaid.nih.gov/publications/immune/page2.htm>
>
> Information about Section 508 \[of the Americans With Disabilities
> Act\] can be found at
> [http://www.section508.gov](http://www.section508.gov/)
>
> NIH Data Sharing Policy
> <http://grants2.nih.gov/grants/policy/data_sharing/index.htm>).
>
> NIH Security Plan Template
> <http://irm.cit.nih.gov/security/secplantemp.doc>

OMB Bulletin 90-08 <http://irm.cit.nih.gov/itmra/omb90-08.html>

NIH Security Plan Template
<http://irm.cit.nih.gov/security/secplantemp.doc>

> Bioinformatics Integration Support Contract (BISC). Additional
> information about BISC can be found at
> <http://www.niaid.nih.gov/research/bisc.htm>
>
> **Contractor's Request to Subcontract Checklist**[]{#subKchecklist
> .anchor}
>
> Prime Contract Number:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Prime Contractor Name and Point of Contact/Address:
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Prime Contract Type: Cost Reimbursement Fixed Price Other
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Proposed Subcontractor Name and Address:
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Proposed Subcontract Type: Cost Reimbursement Fixed Price Other
> \_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Proposed Subcontract cost ceiling or price:
> \$\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **Checklist of Documentation**
>
> ***Contractor: Review the following list and attach the documents
> needed for your specific circumstances. Guidance on required
> documentation can be found in the Federal Acquisition Regulations,
> Part 44. This list is not meant to be all inclusive. This document is
> a tool designed to assist contractors in developing and submitting
> complete packages for expedited consent to subcontract. Please refer
> to the terms and conditions of your contract, NIAID's Standard
> Operating Procedure entitled, "Providing Consent to Subcontract SOP,"
> and FAR Part 44 for all subcontracting requirements.***
>
> **The following documents are being submitted for subcontract
> consent:**
>
> Signed request for consent to subcontract from an individual
> authorized to bind the organization. Submitted with Package
>
> Description of Work to be subcontracted along with a technical
> justification documenting the scientific necessity in relation to the
> project. Submitted with Package
>
> Draft subcontract agreements. Submitted with Package
>
> A written description of attempts to secure competition, or, the
> circumstances which prohibit competition. Submitted with Package
>
> Documentation of a sound basis for selecting the proposed
> subcontractor. Submitted with Package
>
> Documentation of the rationale used to determine the responsibility of
> the proposed subcontractor. Submitted with Package
>
> Confirmation that the proposed subcontractor has current electronic
> [Representations and Certifications]{.underline}. Submitted with
> Package
>
> Confirmation that the proposed subcontractor is not listed on the
> Excluded Parties List System (FAR Subpart 9.4). Submitted with Package
>
> Estimates of the cost impact on the prime budgets. Submitted with
> Package
>
> Cost estimates or pricing information for the subcontract. Submitted
> with Package
>
> Description of the cost or price analysis or price comparisons made
> for the subcontract, or a copy of the analysis.
>
> Submitted with Package
>
> Accurate, complete, and current cost or pricing data, including any
> required certifications. Submitted with Package
>
> Supporting cost documentation, if required, and the negotiated
> indirect rate agreement for proposed subcontractors. Submitted with
> Package Not Required
>
> Confirmation that the prime contractor has complied with applicable
> requirements regarding small business subcontracting. Submitted with
> Package Not Required
>
> Small business subcontracting plans from proposed subcontractors, for
> subcontracts with an estimated cost of \$500,000 or more. Submitted
> with Package Not Required
>
> Three quotations for requested equipment purchases, or, the absence of
> competition has been documented. Submitted with Package Not Required
>
> Human subjects or animal assurance documentation. Submitted with
> Package Not Required
>
> Confirmation of CDC certification or application date for select agent
> use. Submitted with Package Not Required

[^1]:
    > See NIH Guide
    > [<http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm>,]{.underline}
    > for the Definition of an "NIH-Defined Phase III clinical trial.