**U.S. Department of Health and Human Services**

**National Institutes of Health**

**National Institute of Allergy and Infectious Diseases (NIAID)**

[]{#A .anchor}**RFP-NIH-NIAID-DAIDS-06-05**

**Clinical Research Products Management Center**

+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 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.fe |     |   |   |        |     |   |   |                        |
| dbizopps.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 |
| **March 28,    |     |   |   |        |     |   |   |                        |
| 2005**         |  Da |   |   |        |     |   |   | > **8(a) Set-Aside:**  |
|                | te: |   |   |        |     |   |   | > \[ \]Yes \[**X**\]   |
|                |     |   |   |        |     |   |   | > No                   |
|                |     |   |   |        |     |   |   | >                      |
|                | May |   |   |        |     |   |   | > **NAICS #:**         |
|                |     |   |   |        |     |   |   | > [541710]{.underline} |
|                |     |   |   |        |     |   |   | >                      |
|                | 23, |   |   |        |     |   |   | > (See Part IV,        |
|                |     |   |   |        |     |   |   | > Section L.)          |
|                |     |   |   |        |     |   |   |                        |
|                | 200 |   |   |        |     |   |   |                        |
|                | 5** |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                | >   |   |   |        |     |   |   |                        |
|                | **T |   |   |        |     |   |   |                        |
|                | ime |   |   |        |     |   |   |                        |
|                | :** |   |   |        |     |   |   |                        |
|                | >   |   |   |        |     |   |   |                        |
|                | 4** |   |   |        |     |   |   |                        |
|                | :00 |   |   |        |     |   |   |                        |
|                | > p |   |   |        |     |   |   |                        |
|                | .m. |   |   |        |     |   |   |                        |
|                | > , |   |   |        |     |   |   |                        |
|                | >   |   |   |        |     |   |   |                        |
|                |  ES |   |   |        |     |   |   |                        |
|                | T** |   |   |        |     |   |   |                        |
|                | >   |   |   |        |     |   |   |                        |
|                | []{ |   |   |        |     |   |   |                        |
|                | .ma |   |   |        |     |   |   |                        |
|                | rk} |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
|                |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 6.  **Just In  |     | 7 |   |        |     |   | 8 |                        |
|     Time:**    |     | . |   |        |     |   | . |                        |
|                |     |   |   |        |     |   |   |                        |
| > \[**X**\] No |     |   |   |        |     |   |   |                        |
| >              |     | * |   |        |     |   | * |                        |
| > \[ \] Yes    |     | * |   |        |     |   | * |                        |
| > (See Part    |     | N |   |        |     |   | T |                        |
| > IV, Section  |     | u |   |        |     |   | e |                        |
| > L.)          |     | m |   |        |     |   | c |                        |
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|                |     |   |   |        |     |   | } |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
|                |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 9.  **Issued   |     |   |   | 10.    |     |   |   |                        |
|     By:**      |     |   |   |  \[X\] |     |   |   |                        |
|                |     |   |   |     *  |     |   |   |                        |
| Barbara A.     |     |   |   | *NIAID |     |   |   |                        |
| Shadrick       |     |   |   |     re |     |   |   |                        |
|                |     |   |   | serves |     |   |   |                        |
| Contracting    |     |   |   |        |     |   |   |                        |
| Officer        |     |   |   |    the |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
| Contract       |     |   |   |  right |     |   |   |                        |
| Management     |     |   |   |     to |     |   |   |                        |
| Program, DEA   |     |   |   |        |     |   |   |                        |
|                |     |   |   |   make |     |   |   |                        |
| NIH, NIAID     |     |   |   |        |     |   |   |                        |
|                |     |   |   | awards |     |   |   |                        |
| 6700-B         |     |   |   |     w  |     |   |   |                        |
| Rockledge      |     |   |   | ithout |     |   |   |                        |
| Drive          |     |   |   |     d  |     |   |   |                        |
|                |     |   |   | iscuss |     |   |   |                        |
| Room 3214, MSC |     |   |   | ion.** |     |   |   |                        |
| 7612           |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
| Bethesda, MD   |     |   |   |        |     |   |   |                        |
| 20892-7612     |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
|                |     |   |   | ## Opt |     | 1 |   |                        |
|                |     |   |   | ions:  |     | 1 |   |                        |
|                |     |   |   |        |     | . |   |                        |
|                |     |   |   | ##     |     |   |   |                        |
|                |     |   |   |        |     | * |   |                        |
|                |     |   |   | ## \[  |     | * |   |                        |
|                |     |   |   | X\] No |     | P |   |                        |
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|                |     |   |   | > \]   |     | i |   |                        |
|                |     |   |   | >      |     | o |   |                        |
|                |     |   |   |  Yes** |     | d |   |                        |
|                |     |   |   | > (See |     |   |   |                        |
|                |     |   |   | > Part |     |   |   |                        |
|                |     |   |   | > IV,  |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   | S      |     | o |   |                        |
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|                |     |   |   | L.)    |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
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|                |     |   |   |        |     | * |   |                        |
|                |     |   |   |        |     | * |   |                        |
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|                |     |   |   |        |     | 7 |   |                        |
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|                |     |   |   |        |     | 2 |   |                        |
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|                |     |   |   |        |     | 1 |   |                        |
|                |     |   |   |        |     | 3 |   |                        |
|                |     |   |   |        |     | * |   |                        |
|                |     |   |   |        |     | * |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     | # |   |                        |
|                |     |   |   |        |     | # |   |                        |
|                |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 12. Primary    |     |   | 1 |        |     |   |   | 14. **Protest          |
|     Point of   |     |   | 3 |        |     |   |   |     Officer:**         |
|     Contact:   |     |   | . |        |     |   |   |                        |
|                |     |   |   |        |     |   |   | Charles W. Grewe       |
| Name : Dominic |     |   | * |        |     |   |   |                        |
| Reeves         |     |   | * |        |     |   |   | > Program Director,    |
|                |     |   | S |        |     |   |   | > CMP                  |
| **Phone:**     |     |   | e |        |     |   |   | >                      |
| 301-451-3683   |     |   | c |        |     |   |   | > Address (see Block   |
|                |     |   | o |        |     |   |   | > 9.)                  |
| **Fax:**       |     |   | n |        |     |   |   |                        |
| 301-402-0972   |     |   | d |        |     |   |   |                        |
|                |     |   | a |        |     |   |   |                        |
| **E-Mail:**    |     |   | r |        |     |   |   |                        |
| <dreeves@      |     |   | y |        |     |   |   |                        |
| niaid.nih.gov> |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
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|                |     |   | * |        |     |   |   |                        |
|                |     |   | < |        |     |   |   |                        |
|                |     |   | d |        |     |   |   |                        |
|                |     |   | l |        |     |   |   |                        |
|                |     |   | i |        |     |   |   |                        |
|                |     |   | s |        |     |   |   |                        |
|                |     |   | l |        |     |   |   |                        |
|                |     |   | e |        |     |   |   |                        |
|                |     |   | @ |        |     |   |   |                        |
|                |     |   | n |        |     |   |   |                        |
|                |     |   | i |        |     |   |   |                        |
|                |     |   | a |        |     |   |   |                        |
|                |     |   | i |        |     |   |   |                        |
|                |     |   | d |        |     |   |   |                        |
|                |     |   | . |        |     |   |   |                        |
|                |     |   | n |        |     |   |   |                        |
|                |     |   | i |        |     |   |   |                        |
|                |     |   | h |        |     |   |   |                        |
|                |     |   | . |        |     |   |   |                        |
|                |     |   | g |        |     |   |   |                        |
|                |     |   | o |        |     |   |   |                        |
|                |     |   | v |        |     |   |   |                        |
|                |     |   | > |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 15. **COLLECT  |     |   |   |        |     |   |   |                        |
|     CALLS WILL |     |   |   |        |     |   |   |                        |
|     NOT BE     |     |   |   |        |     |   |   |                        |
|     ACCEPTED.  |     |   |   |        |     |   |   |                        |
|     FACSIMILE  |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|    SUBMISSIONS |     |   |   |        |     |   |   |                        |
|     ARE NOT    |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|  ACCEPTABLE.** |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 16. 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) |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
|                |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 17. DELIVERY   |     |   |   |        |     |   |   |                        |
|     ADDRESS    |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|    INFORMATION |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 19\. Hand      |     |   |   |        | #   |   |   |                        |
| Delivery or    |     |   |   |        | ##  |   |   |                        |
| Overnight      |     |   |   |        | 20. |   |   |                        |
| Service:       |     |   |   |        |  U. |   |   |                        |
|                |     |   |   |        | S.  |   |   |                        |
| Dominic Reeves |     |   |   |        | Pos |   |   |                        |
|                |     |   |   |        | tal |   |   |                        |
| Contract       |     |   |   |        |  Se |   |   |                        |
| Management     |     |   |   |        | rvi |   |   |                        |
| Program, DEA   |     |   |   |        | ce  |   |   |                        |
|                |     |   |   |        | or  |   |   |                        |
| NIAID, NIH     |     |   |   |        | an  |   |   |                        |
|                |     |   |   |        | Exp |   |   |                        |
| 6700-B         |     |   |   |        | res |   |   |                        |
| Rockledge      |     |   |   |        | s D |   |   |                        |
| Drive, Room    |     |   |   |        | eli |   |   |                        |
| 3214           |     |   |   |        | ver |   |   |                        |
|                |     |   |   |        | y S |   |   |                        |
| Bethesda, MD   |     |   |   |        | erv |   |   |                        |
| 20817          |     |   |   |        | ice |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        | D   |   |   |                        |
|                |     |   |   |        | omi |   |   |                        |
|                |     |   |   |        | nic |   |   |                        |
|                |     |   |   |        | Ree |   |   |                        |
|                |     |   |   |        | ves |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        | Co  |   |   |                        |
|                |     |   |   |        | ntr |   |   |                        |
|                |     |   |   |        | act |   |   |                        |
|                |     |   |   |        | M   |   |   |                        |
|                |     |   |   |        | ana |   |   |                        |
|                |     |   |   |        | gem |   |   |                        |
|                |     |   |   |        | ent |   |   |                        |
|                |     |   |   |        | Pr  |   |   |                        |
|                |     |   |   |        | ogr |   |   |                        |
|                |     |   |   |        | am, |   |   |                        |
|                |     |   |   |        | DEA |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        | NIA |   |   |                        |
|                |     |   |   |        | ID, |   |   |                        |
|                |     |   |   |        | NIH |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        | 670 |   |   |                        |
|                |     |   |   |        | 0-B |   |   |                        |
|                |     |   |   |        | Roc |   |   |                        |
|                |     |   |   |        | kle |   |   |                        |
|                |     |   |   |        | dge |   |   |                        |
|                |     |   |   |        | Dri |   |   |                        |
|                |     |   |   |        | ve, |   |   |                        |
|                |     |   |   |        | R   |   |   |                        |
|                |     |   |   |        | oom |   |   |                        |
|                |     |   |   |        | 32  |   |   |                        |
|                |     |   |   |        | 14, |   |   |                        |
|                |     |   |   |        | MSC |   |   |                        |
|                |     |   |   |        | 7   |   |   |                        |
|                |     |   |   |        | 612 |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        | Bet |   |   |                        |
|                |     |   |   |        | hes |   |   |                        |
|                |     |   |   |        | da, |   |   |                        |
|                |     |   |   |        | MD  |   |   |                        |
|                |     |   |   |        | 2   |   |   |                        |
|                |     |   |   |        | 089 |   |   |                        |
|                |     |   |   |        | 2-7 |   |   |                        |
|                |     |   |   |        | 612 |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 21\. The       |     |   |   |        |     |   |   |                        |
| **[Official    |     |   |   |        |     |   |   |                        |
| Point of       |     |   |   |        |     |   |   |                        |
| Receipt]       |     |   |   |        |     |   |   |                        |
| {.underline}** |     |   |   |        |     |   |   |                        |
| for the        |     |   |   |        |     |   |   |                        |
| purpose of     |     |   |   |        |     |   |   |                        |
| determining    |     |   |   |        |     |   |   |                        |
| timely         |     |   |   |        |     |   |   |                        |
| delivery is    |     |   |   |        |     |   |   |                        |
| the address    |     |   |   |        |     |   |   |                        |
| provided in    |     |   |   |        |     |   |   |                        |
| Block 19,      |     |   |   |        |     |   |   |                        |
| above. The     |     |   |   |        |     |   |   |                        |
| original paper |     |   |   |        |     |   |   |                        |
| copy with      |     |   |   |        |     |   |   |                        |
| original       |     |   |   |        |     |   |   |                        |
| signatures is  |     |   |   |        |     |   |   |                        |
| the official   |     |   |   |        |     |   |   |                        |
| copy for       |     |   |   |        |     |   |   |                        |
| recording      |     |   |   |        |     |   |   |                        |
| timely         |     |   |   |        |     |   |   |                        |
| receipt. If    |     |   |   |        |     |   |   |                        |
| the original   |     |   |   |        |     |   |   |                        |
| 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.    |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+

Updated thru FAC 2001-27 (12/28/2004)

**TABLE OF CONTENTS**

**[SECTION A](#A) \-- SOLICITATION/CONTRACT FORM COVER PAGE**

[**BACKGROUND**](#B)

[**SCOPE OF WORK / STATEMENT OF WORK**](#C)

[**REPORTING REQUIREMENTS and OTHER DELIVERABLES**](#D)

[**SECTIONS B --
H**](#sections-b---h----uniform-contract-format---general) \-- **UNIFORM
CONTRACT FORMAT -- GENERAL**

**[SECTION I](#F) \-- GENERAL CLAUSES and ADDITIONAL CLAUSES /
SUBSTITUTED CLAUSES**

> **[ARTICLE I.1.](#G) General Clauses**

### [ARTICLE I.2](#H). Authorized Substitutions Of Clauses

### [ARTICLE I.3.](#article-i.3.-additional-contract-clauses-1) Additional Contract Clauses

### [ARTICLE I.4.](#J) Additional Far Contract Clauses Included In Full Text

[**SECTION J \-- LIST OF ATTACHMENTS**](#K)

**\[includes proposal submission instructions, page limitations and
electronic file size limitations\]**

**[SECTION
K](#section-k---representations-certifications-and-other-statements-of-offerors)
\-- REPRESENTATIONS AND CERTIFICATIONS AND OTHER STATEMENTS**

> **OF OFFERORS OR QUOTERS (NEGOTIATED)**
>
> **\[If you intend to submit a proposal, you MUST complete this
> document and submit it as part of your Business Proposal. If you are
> unable to access this document electronically, you may request a copy
> from the Contracting Officer identified on the cover page of this
> solicitation.\]**

**[SECTION
L](#section-l---instructions-conditions-and-notices-to-offerors) \--
INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS**

> [**I. General Information**](#O)
>
> [**II. General Instructions**](#P)

[**III. Technical Proposal
Instructions**](#iii.-technical-proposal-instructions)

[**IV. Business Proposal
Instructions**](#iv.-business-proposal-instructions)

**[SECTION M](#section-m---evaluation-factors-for-award) \-- EVALUATION
FACTORS FOR AWARD**

**[APPENDIX A](#T) - ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS AND**

**FORMAT FOR [TECHNICAL PROPOSAL]{.underline} -- [TABLE OF
CONTENTS]{.underline}**

**[APPENDIX B](#U) - ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS AND
UNIFORM COST ASSUMPTIONS**

**[APPENDIX C](#V) - OVERVIEW OF DAIDS-SPONSORED HIV/AIDS CLINICAL
TRIALS NETWORKS AND SELECTED DAIDS SUPPORT CONTRACTS**

**[APPENDIX D](#W) - LIST OF GOVERNMENT FURNISHED PROPERTY**

**[APPENDIX E](#X) -- CLINICAL TRIAL CASE STUDIES**

[]{#B .anchor}**BACKGROUND**

Since its inception in 1987, the Division of AIDS (DAIDS), National
Institute of Allergy and Infectious Diseases (NIAID), has designed,
developed and sponsored extramural Clinical Trials Networks to develop
and optimize therapies, vaccines and prevention modalities for Human
Immunodeficiency Virus /Acquired Immune Deficiency Syndrome (HIV/AIDS).
These Networks have played a vital role in HIV and AIDS research,
providing the critical mass and infrastructure for both quality and
continuity in collaborative, protocol-driven clinical research. The
contributions and progress made by these Networks and their antecedents,
the Adult and Pediatric AIDS Clinical Trials Groups (ACTG), the AIDS
Vaccine Evaluation Group (AVEG), and the HIV Network for Prevention
Trials (HIVNET), have been unparalleled and have advanced HIV clinical
science around the world.

The mission of the DAIDS is to help ensure an end to the HIV/AIDS
epidemic by increasing basic knowledge of the pathogenesis and
transmission of the HIV, supporting the development of therapies for HIV
infection and its complications, and supporting the development of
vaccines and other prevention strategies. This mission is carried out by
three Programs within the Division: the Basic Sciences Program, the
Therapeutics Research Program, and the Vaccine and Prevention Research
Program. DAIDS sponsors the conduct of Phase I, II, III and IV human
clinical trials involving the testing of vaccines and therapeutics, as
well as preventive modalities such as microbicides. Through grants and
contracts, DAIDS currently funds more than 125 clinical trials in 40
countries at over 900 sites with more than 50,000 volunteers.

To support its clinical research programs, DAIDS utilizes the services
of a Clinical Research Products Management Center (CRPMC) to provide for
the storage and distribution of investigational study products used in
DAIDS-funded clinical trials. The CRPMC provides a central location to
receive, store, repackage, label, distribute, and recall study products
in accordance with all Federal regulations governing investigational
agents. In addition, the CRPMC supports the site monitoring and training
activities of the NIAID, DAIDS, and the DAIDS Pharmaceutical Affairs
Branch (PAB). The CRPMC will serve current and future DAIDS-sponsored
Clinical Trials Networks and collaborating study groups. The current
NIAID-sponsored HIV/AIDS Clinical Trials Networks and the
accomplishments of each are described in APPENDIX C, Overview of
DAIDS-Sponsored HIV/AIDS Clinical Trials Networks and Selected DAIDS
Support Contracts.

DAIDS also has entered into contracts that provide clinical research
support to sites conducting DAIDS-sponsored research. Activities
conducted by these contractors include clinical site monitoring,
laboratory quality assurance, specimen storage, training, and regulatory
assistance. See APPENDIX C for a description of these current DAIDS
contracts. Additional information about current contracts may also be
found at:

<http://www.niaid.nih.gov/daids/rfa/network06/current_daids_contract_resources.htm>

In order to provide the investigational study products for the clinical
trials specified above, a five year contract was awarded on August 15,
1993, under the project title "Storage, Repackaging and Distribution of
Investigational Agents for AIDS." Subsequently, a recompetition of that
contract resulted in an award on August 15, 1998, under the project
title "NIAID Clinical Research Products Management Center" to McKesson
BioServices, Contract No. N01-AI-85352. This solicitation is a
recompetition of the current contract. The NIAID anticipates awarding
one contract for a period of seven (7) years to perform the CRPMC
functions specified in the Statement of Work.

**NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)**

**CLINICAL RESEARCH PRODUCTS MANAGEMENT CENTER (CRPMC)**

[]{#C .anchor}**[SCOPE OF WORK]{.underline}**

This contract is for the establishment and operation of the Clinical
Research Products Management Center (CRPMC) to support the Division of
AIDS (DAIDS) clinical trials networks and programs in the United States
and international locations. The CRPMC will be responsible for the
management and oversight of all internationl CRPMCs; hereinafter
referred to as ICRPMCs, that will perform the same functions. All
functions must be conducted in accordance with Federal, local and
international regulations governing study products. The CRPMC will
provide cognitive pharmaceutical services including evaluating draft
protocols and interacting with DAIDS regarding implementation issues;
reviewing site pharmacy audits, and maintaining a database of these
reports; providing product storage and stability information, guidance
in research pharmacy practice and product management activities to
clinical site pharmacists; and conducting cGMP audits of manufacturing
facilities. Additionally, the CRPMC will provide technical expertise for
the receipt of study products; appropriate storage under GMP criteria;
validate containers for the shipment of study products under correct
temperature conditions; evaluate orders for appropriateness, distribute
study products to only authorized investigators with all required
shipping documents; design and label study products and product kits;
package and repackage study products under GMP; monitor product
inventories and expiration dates; recall and process product returns,
and maintain a database of product management activities. The CRPMC will
train all internal staff in critical procedures and under limited
circumstances, purchase drugs.

**[STATEMENT OF WORK]{.underline}**

Independently and not as an agent of the Government, the Contractor must
furnish services, qualified personnel, material, equipment and
facilities not otherwise provided by the Government under the terms of
this contract as needed to perform the work set forth below.
Specifically the Contractor is required to perform the following tasks:

1.  Initial Transition (Contract Start-up)

2.  Pharmaceutical Services

3.  Receipt and Storage of Study Products

4.  Labeling, Packaging and Repackaging of Study Products

5.  Shipping Preparation Procedures and Equipment

6.  Shipping and Distribution of Study Products

7.  Shipping Documents and Regulations

8.  Inventory Management

9.  cGMP, Sanitation and Environmental Control

10. Security and Safety of Study Products

11. Internal Training of CRPMC and ICRPMC Staff

12. Final Disposition of Study Products

13. Data Management

14. Administrative Support

15. Purchase of Study Products

16. Management and Oversight of ICRPMCs

17. Final Transition (Contract Completion)

In addition to the domestic CRPMC, there will be one or more
International CRPMCs (ICRPMC) depending on the requirements of the
clinical research studies being conducted at any particular time. The
support to be provided under the above-named tasks is detailed below:

1.  **INITIAL TRANSITION (CONTRACT START-UP)**

    a.  Provide for the safe and efficient assumption of activities from
        the current contractor to ensure a seamless transition without
        loss of time, loss of products or that would not pose obstacles
        to the conduct of ongoing clinical trials. Provide training time
        associated with the transfer and operation of the current CRPMC.

    b.  The transition must be accomplished within the first 45 calendar
        days following the effective date of the contract. The functions
        of the CRPMC must be maintained during the transition period,
        and distribution of the study products for Division of AIDS
        (DAIDS) studies must not be interrupted at any time.

    c.  Implement the Transition Plan including the tasks that are
        associated with the relocation effort from the current
        contractor and the manner of operations required by the NIAID
        Project Officer during the transisiton period. This includes the
        effective coordination with the current contractor at the start
        of the new contract period for safe transfer of contract-related
        materials, including:

-   Study product inventory

-   Inventory records

-   Files of correspondence with product manufacturers, clinical
    research sites, and DAIDS

-   Shipping records

-   Databases, software systems and other software

-   Government-furnished property

-   Shipping materials, cartons, labels, packing and materials

-   Validated shipping procedures

-   NIAID approval documents

-   Certificates of Analysis and any other items requiring maintainance
    by the CRPMC for the duration of the contract

    d.  In the event of a transition to a successor contractor, the
        current CRPMC will provide to the new contractor the existing
        Oracle data base management system of the CRPMC, the Clinical
        Products Inventory Management System (CPIMS), containing
        information on inventory, and necessary documentation of the
        activities of the CRPMC. A major component of the system is the
        module to track individual investigators' product requests.
        Other modules support production of standard reports, such as
        receiving and shipping. More specialized reports including
        inventory by product and by study protocol, list of clinical
        research sites and pharmacists of record will also be made
        available. The CRPMC computer files will be transferred.

2.  **PHARMACEUTICAL SERVICES**

    a.  [Protocol Evaluation and Development]{.underline}

        1.  Review and evaluate at least two drafts of each clinical
            trial protocol received from the Clinical Trials Networks
            Coordinating and Operations Centers (COREs) or from DAIDS
            Pharmaceutical Affairs Branch (PAB): [first]{.underline},
            the draft protocol that is submitted for initial review by
            either DAIDS Clinical Sciences Review Committee or DAIDS
            Prevention Sciences Review Committee and
            [second]{.underline}, a near final draft of the protocol.
            Additional protocol evaluations shall be performed at the
            request of the NIAID Project Officer when there are major
            changes. [Examples of changes include]{.underline}: the
            addition or deletion of study products; changes in the
            number of sites conducting the protocol; an expansion of the
            trial to include international sites; and changes in the
            sample size, dosage, dosage forms, protocol design, and
            trial population.

        2.  Within one week of receipt of the initial review version of
            the protocol, provide the NIAID Project Officer with a
            written protocol evaluation, usually 1-2 pages in length,
            that includes estimates of the quantity of study products
            needed and requirements for study product handling or
            packaging .

        3.  Provide and use a commercially available software system
            that projects the quantity of study product required for
            individual protocols based on multiple protocol
            specifications and requirements, including:

            -   sample size

            -   enrollment rate

            -   number of participating clinical research sites

            -   randomized treatment

            -   subject population

            -   dosage form requirements

            -   stability of dosage form

            -   subject discontinuation

            -   protocol-specific visit schedule.

        4.  Generate protocol-specific documents for each final protocol
            approved by DAIDS that provide product ordering information,
            including study product packaging, dosage-strength, and
            labeling. Distribute to Pharmacists of Record (PoRs) after
            approval by the NIAID Project Officer. Generate a new
            version of the protocol-specific document for each final
            version of a protocol. Provide to PoRs the new version of
            the protocol-specific document when there are any changes
            that affect the ordering of study products. The current
            version of the protocol-specific document is to be
            distributed to additional clinical research sites as they
            are registered for participation in the clinical trial or as
            requested by the PoR.

        5.  Maintain a protocol-specific file for each protocol,
            including any hard copy documents and electronic
            communications at the CRPMC and ICRPMC.

    b.  [Evaluation of Study Product Usage]{.underline}

> Provide evaluations of current study product usage and projections of
> anticipated requirements to product manufacturers on a quarterly basis
> or as needed to meet the requirements of product manufacturers. Some
> evaluations will require projection of usage needs one to two years in
> advance. All evaluations must be submitted to the NIAID Project
> Officer for review and approval before transmittal to the product
> manufacturers. These projections will include requirements for both
> international and United States sites.

c.  [Meetings]{.underline}

> To ensure the effective management of this contract, the Contractor
> must be able to accommodate the needs of the PAB with respect to
> frequent interactions, including weekly protocol review meetings with
> PAB pharmacists, at least bi-weekly site pharmacy monitoring report
> meetings, and face-to-face within 24 hours to resolve emergent and
> urgent issues.

1.  [CRPMC and PAB Meetings]{.underline}: Meet with the NIAID Project
    Officer and PAB staff on a weekly basis for one to two hours. These
    meetings will take place at the offices of DAIDS, 6700-B Rockledge
    Drive, Bethesda, Maryland, and will include all CRPMC staff
    pharmacists.

    a.  The CRPMC is responsible for providing a hardcopy updated report
        for each attendee at the beginning of the meeting that
        identifies the current status of protocols in development and
        other protocol-specific issues such as:

-   pending expiration dates of study products

-   shortage of study product

-   country-specific shipping requirements

-   protocols identified as requiring close monitoring

-   protocols on hold

-   additional study products added to ongoing protocols.

    a.  PAB pharmacists will update the CRPMC pharmacists on the status
        of protocols included in the report. CRPMC will have the
        opportunity to address any issues that need discussion with the
        NIAID Project Officer and PAB staff.

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    1.  [Site Pharmacy Monitoring Report Meetings]{.underline}: Meet on
        a weekly basis, as necessary, for one to two hours with the
        NIAID Project Officer and PAB staff at the offices of DAIDS to
        discuss site pharmacy monitoring reports generated by a Clinical
        Site Monitoring Contractor (CSMC). The reports are sent
        electronically to the CRPMC

> and reviewed by the CRPMC. Monitoring meetings will not be held in
> conjunction with the weekly CRPMC and PAB meetings described in item
> 1), above, due to the length of time that the two combined meeting
> would require. The CRPMC pharmacists responsible for supporting
> monitoring activities will participate in the meetings. The CRPMC
> pharmacists are responsible for developing the meeting agenda based on
> their review of site pharmacy monitoring reports. The CRPMC
> pharmacists is responsible for all required follow-up actions as
> determined by the NIAID Project Officer and PAB staff.

2.  [Clinical Trials Network Meetings]{.underline}: Attend meetings of
    the DAIDS-funded Clinical Trials Networks, to be held within a 50
    mile radius of Washington, D.C., to participate in the clinical
    research site pharmacists meetings organized by PAB. It is expected
    that all CRPMC pharmacists will attend the clinical research site
    pharmacists meeting. The CRPMC Principal Investigator and one or two
    other pharmacists will attend the entire meeting. The Clinical
    Trials Network meetings are generally three to four days in length.
    In addition, meetings with the CORE and Clinical Trials Networks
    Statistical and Data Management Center (SDMC) of the Clinical Trials
    Networks may be required. These meetings may or may not be in the
    Washington, D.C. area.

3.  [Additional Meetings]{.underline}: Attend impromptu meetings in the
    Washington, D.C. vicinity with the NIAID Project Officer and with
    other individuals who represent companies or institutions
    collaborating with DAIDS. The purpose of these meetings is to
    discuss study product requirements such as storage, labeling,
    repackaging, shipping, and logistical shipping issues.

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a.  [Study Products]{.underline}

    1.  Process authorized requests received by fax, mail, electronic
        mail or web-based (if such is developed by the CRPMC) for study
        products on a daily basis, evaluating each order for
        appropriateness and confirming that the order originates from a
        PoR designated by a DAIDS-authorized clinical research site
        investigator. The appropriateness of the order shall be
        determined by the previous ordering history of the clinical
        research site, its current study product inventory, number of
        patients in the study, and any other special requirements for
        the study. Task to be completed by domestic and international
        CRPMCs.

    2.  Provide study product information (e.g., special handling or
        shipping or study product availability) to the PoR upon request.

    3.  Provide study product order, transfer, return or final
        disposition information to the PoRs as requested by the PoRs.

    4.  Contact the study product manufacturers to ascertain whether a
        study product's repass or expiration date has been extended.
        Notify the PoRs if the study product manufacturer indicates that
        the repass or expiration dates have been changed.

    5.  Consult the study product manufacturer to determine if a study
        product provided for one protocol can be transferred for use in
        another protocol. If the transfer is approved, authorize the PoR
        to transfer within the site the product from one protocol to
        another (or other protocols) designated by the CRPMC.

    6.  Obtain from the PoRs, either by fax or electronic file transfer,
        any accountability records needed by the CRPMC to determine
        appropriate quantities for shipping to international locations.

    7.  Obtain and provide to DAIDS PAB, current Average Wholesale
        Prices for study products using [Drug Topics® Red
        Book®]{.underline} on CD-ROM to provide to protocol teams for
        budget estimating purposes.

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e.  [Certificates of Analysis (CoAs)]{.underline}

> Ensure that a legible Certificate of Analysis (CoA) is obtained from
> study product manufacturers and is available for each lot of study
> product. The CRPMC will initially review the CoA for completeness and
> consistency prior to submission to the NIAID Project Officer. The
> CRPMC will provide a signoff coversheet to document the approval or
> disapproval of each member of DAIDS Quality Assurance Committee (QAC)
> that includes the NIAID Project Officer.
>
> If issues are identified in the CoA by DAIDS QAC such as discrepancies
> with the lot numbers, descriptions, specifications versus results,
> potency, or units of measurement indicated, the CRPMC must consult
> with the product manufacturer for resolution. Retain all original CoAs
> and the approval documents for the duration of the contract. The
> specific lot of study product may only be shipped to the PoR after the
> approval of the DAIDS QAC is received.
>
> If a product is shipped directly to the ICRPMC, the CoA must be
> forwarded to the CRPMC. The CRPMC will follow the above process.

f.  [Review of Pharmacy Site Visit Reports]{.underline}

    1.  Support the pharmacy monitoring oversight responsibilities of
        DAIDS PAB by reviewing pharmacy site visit reports submitted by
        the DAIDS Clinical Site Monitoring Contractor (CSMC) to identify
        issues and concerns, and inform the NIAID Project Officer of
        critical findings such as diversion of study product, study
        product dispensing errors, dispensing study products without a
        prescription, dispensing study products without a signed
        informed consent, or suspicion of scientific misconduct reported
        by the monitor. The CRPMC may review approximately 1000-1500
        pharmacy site monitoring reports per year within three weeks of
        receipt of the report. This review will adhere to the following
        procedure:

        a.  Enter into a database located at the CRPMC the clinical
            research site number, clinical research site name, site
            pharmacist, monitor, visit date, the date information is
            entered into the database, type of report, and in a comment
            field any issues identified and actions (see c), d), or e),
            below) taken by the CRPMC pharmacists.

        b.  Review any previous comments in the database for that
            particular site; identify if the cause for action is a new
            occurrence or a repeat occurrence.

        c.  Add any site with a repeat occurrence to the list of
            candidate sites requiring additional monitoring.

        d.  Immediately notify the NIAID Project Officer of any critical
            findings.

        e.  If pharmacy site visit reports do not specify that requests
            were made by the monitor for corrective action, contact the
            CSMC to ask for clarification if actions were requested.

        f.  Provide the list of sites that potentially require
            additional monitoring to the NIAID Project Officer on a
            quarterly basis.

        g.  Maintain an electronic file of all pharmacy site visit
            reports and the capacity to retrieve any specific report for
            forwarding to the NIAID Project Officer.

        h.  Provide electronic copies of requested reports within four
            hours of request or within one hour on an urgent basis
            during normal working hours.

g.  [Pharmacy Site Visits]{.underline}

    1.  In support of PAB pharmacy monitoring responsibilities, CRPMC
        staff is required to conduct site visits to any clinical
        research site to review pharmacy activities as directed by the
        NIAID Project Officer. This is in addition to the monitoring
        conducted by the CSMC. A written report must be submitted to the
        NIAID Project Officer within 10 business days after completion
        of the site visit.

    2.  Provide technical guidance and advice to clinical research site
        pharmacists regarding the acquisition of necessary equipment,
        such as refrigerators, freezers, air conditioning, and
        dehumidifiers, and the installation and maintenance of equipment
        to monitor temperature controlled and cold storage areas. The
        NIAID Project Officer will inform the CRPMC which sites are to
        receive this guidance.

    3.  Support the PAB clinical site pharmacy site establishment
        activities. This includes, for example, assistance with the
        development of site pharmacy standard operating procedures
        (SOPs), guidance to ensure the pharmacy is equipped to conduct
        clinical trials, and guidance in the development of
        pharmaceutical care in the context of research pharmacy/clinical
        research and protocol-specific procedures. This may require
        travel to a site pharmacy by one pharmacist for five working
        days to ensure that the pharmacy meets the requirements of the
        International Conference on Harmonization, U.S. Food and Drug
        Administration (FDA), and the local requirements of the
        jurisdiction where the pharmacy is located. Provide the NIAID
        Project Officer with a written summary of the guidance
        activities within 10 business days of completion of clinical
        site visit.

    4.  Provide guidance to PoRs aimed at the development and
        implementation of a clinical site pharmacy Quality Assurance
        (QA) program to those clinical research site pharmacies that
        need improvement in their QA program.

    5.  Maintain a list of changes at clinical research site pharmacies
        in a database located at the CRPMC that includes changes in
        staff, location, and contact information, and provide updated
        listings to the NIAID Project Officer on a quarterly basis for
        monitoring purposes.

h.  [Current Good Manufacturing Practices (cGMP) Audits]{.underline}

> Perform audits of product manufacturing facilities to determine
> adherence to current cGMP standards. The facilities to be audited will
> be identified by the NIAID Project Officer, and may be in the United
> States or at international locations. Audits are to be performed
> within 60 days after the need is identified. Provide a written report
> following a cGMP audit format that indicates whether or not cGMP
> standards are being met to the NIAID Project Officer within 15
> business days after completion of each audit.

3.  **RECEIPT AND STORAGE OF STUDY PRODUCTS**

> The NIAID Project Officer will provide the product manufacturer with
> the DAIDS official letter of request for study products to be shipped
> by the product manufacturer to the CRPMC. A copy of these letters will
> be provided to the CRPMC.

a.  Work directly with the product manufacturer to arrange for each
    shipment. Depending on the protocol, the ICRPMC may be required to
    contact in-country study product manufacturers or the distributor
    for that region directly.

b.  Receive shipments of study products from a variety of sources,
    including domestic pharmaceutical manufacturers, pharmaceutical
    packaging firms that manufacture or package a non-commercially
    available study product under contract to DAIDS, commercial
    pharmaceutical companies, and foreign pharmaceutical suppliers.
    Shipments received must be reconciled with shipping lists and the
    condition of the shipment must be noted. ICRPMCs shall notify the
    CRPMC Principal Investigator (PI) immediately by e-mail or fax of
    any discrepancies or problems. The CRPMC PI will then notify the
    NIAID Project Officer immediately by e-mail or fax of these reported
    discrepancies or problems.

c.  Perform inspection and QA of study products received from the study
    product manufacturer, wholesaler or other sources for distribution
    to the clinical research sites. The QA is to be performed on the
    condition of the study product, labeling, primary and secondary
    packaging, and for all pharmaceutical dosage forms. This QA should
    also be performed on protocol-required devices and supplies such as
    electronic adherence measuring devices and associated devices for
    downloading data, thermometers, oral syringes, and adaptors for
    transferring liquids from bottles to syringes, syringes for
    injection, pregnancy test kits that are received at the CRPMC or
    ICRPMC for distribution to the study sites.

d.  By close of the next business day following notification of arrival,
    receive and process through Customs any shipments that arrive from a
    supplier in another country.

e.  The CRPMC and the ICRPMC will provide storage facilities and store
    products as indicated in protocols or by the manufacturer:

-   ‑80°C

-   ‑20°C to ‑10°C

-   2°C to 8°C

-   cool temperature, United States Pharmacopoeia (USP)

-   room temperature

-   controlled room temperature, USP

f.  For products received prior to release for shipment, provide a
    quarantine area at the appropriate temperature at the CRPMC and the
    ICRPMC:

    -   ‑80°C

    -   ‑20°C to ‑10°C

    -   2°C to 8°C

g.  The CRPMC and the ICRPMC will provide monitoring of storage
    conditions to guarantee and document continuous proper storage
    through the use of temperature recording monitoring equipment.

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4.  **LABELING, PACKAGING AND REPACKAGING OF STUDY PRODUCTS**

> Any tasks in this section performed by the ICRPMC will be performed
> under the direction of the CRPMC and must be in accordance with the
> CRPMC's Standard Operating Procedures (SOPs).

a.  Label, package and/or repackage study products for suitable
    dispensing to individual patients in clinical studies, as required
    by the needs of the clinical trials. Oral dosage forms are most
    commonly repackaged into bottles. Repackaging may require procuring
    customized boxes to accommodate study products. When applicable,
    randomization schemes with patient numbers and corresponding
    treatment assignments will be supplied to the CRPMC by the NIAID
    Project Officer, or directly by a SDMC of the DAIDS-funded Clinical
    Trials Networks for the purpose of packaging and labeling blinded
    study supplies for patient-specific randomization schemes.
    Compliance with cGMP record maintenance and quality measures is
    required. The CRPMC also is required to provide and maintain the
    necessary clean room(s) and equipment for the repackaging of study
    products.

b.  Provide patient-specific, unit-of-use packaging, including blister
    packaging, for solids, liquids, injections, topical, and powder
    dosage forms, when required by the protocol.

c.  Perform the analytical work required for study product identity
    testing on any study product that has been bottled, packaged or
    blister packaged.

d.  Provide equipment and supplies needed to design and generate
    appropriate labels for study products. This includes labeling
    envelopes containing medication patches, assembling custom kits,
    labeling gel packets, labeling secondary packaging and procuring
    customized boxes to accommodate the study products. In special
    situations, label preparation may be subcontracted, but the actual
    labeling must be performed at the prime contractor's facility.

e.  Provide a hardcopy sample of all labels to the NIAID Project Officer
    for approval prior to affixing to a study product. These label
    samples need to be available for review either the same day they are
    generated or, at the latest, the day following receipt of the
    request from the NIAID Project Officer. If labels are not approved
    then a new version of a label will be generated until an approvable
    version is produced.

f.  Provide one sample of each of the repackaged, labeled study products
    to the NIAID Project Officer for approval prior to completion of the
    activity and distribution to the PoRs. If the NIAID Project Officer
    does not give approval, then corrections in the procedure will be
    made until the NIAID Project Officer is able to approve the sample.

g.  Ship samples of study products to product manufacturers or
    analytical laboratories as required by the NIAID Project Officer.

h.  Affix primary or auxiliary labels on study products and on secondary
    packaging.

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4.  **SHIPPING PREPARATION PROCEDURES AND EQUIPMENT**

    a.  Conduct validation testing of the procedures for the packaging
        and shipping of study products under appropriate temperature
        conditions ranging from -80°C to controlled room temperature,
        USP, as well as the conditions required for controlled
        substances (as defined by the U.S. Drug Enforcement Agency),
        biologics, ethanol-containing products, electronic devices,
        hazardous goods, and for products sensitive to air pressure,
        humidity, vibrations, and carbon dioxide for the purpose of
        supporting the shipping logistics to any DAIDS-funded clinical
        research site.

    b.  Prepare and implement SOPs for shipping based on results of the
        validation testing.

    c.  Provide the equipment to prepare large and small shipments of a
        variety of study products for both international and domestic
        clinical research sites.

5.  **SHIPPING AND DISTRIBUTION OF STUDY PRODUCTS**

> All tasks in this section to be performed by the ICRPMC must be in
> accordance with the CRPMC's SOPs.

a.  Ship study products to PoRs, as designees of DAIDS-approved
    investigators in the United States and internationally, so that
    shipments are routinely received in the United States within 24
    hours and internationally within 3-5 days.

b.  After study product orders have been evaluated, fill orders with
    appropriate protocol-specific study products for subsequent packing
    and shipping.

c.  Provide shipping cartons, cushioning materials, appropriate labels,
    sealing tape, insulation materials, validated shipping containers,
    and all other supplies to ensure the safe, intact arrival of the
    contents of each package being shipped.

d.  Provide appropriate packaging components (for example, wet ice, dry
    ice, or cold packs) to ensure the safe, intact arrival of study
    products requiring maintenance of low temperatures.

e.  Supply reusable, electronic monitoring devices for temperature,
    humidity, and environmental gases. Provide the software for
    downloading, reading and review of the data from the electronic
    monitoring device.

f.  Provide the clinical research sites with a cushioned mailer with a
    CRPMC or ICRPMC return label and prepaid postage/courier label for
    returning the electronic monitoring devices.

g.  Review the shipping data within four of the CRPMC's or ICRPMC's
    normal working hours or by the close of business, which ever is
    earlier, of the return of the monitoring device. Inform the PoR if
    the study product is acceptable for use or if the study product
    needs to be quarantined. If not, the CRPMC will contact the study
    product manufacturer by e-mail if the shipping data from the
    monitoring device indicates deviations from the product
    specifications. Based on the product manufacturer's response, inform
    the PoR whether the study products can be used or must be returned
    to the CRPMC. The ICRPMC will contact the product manufacturer if a
    study product is shipped directly to the ICRPMC.

h.  Maintain a database of all information downloaded from electronic
    monitoring devices. This database is to be maintained by protocol,
    study product, individual shipment, date, site, and lot number for
    the duration of the protocol, as required in 21 CFR 312.57, or for
    the life of the contract, if that is of shorter duration.
    Information downloaded from the electronic monitoring devices shall
    be made available upon request as an Adobe .pdf file, either
    electronically or by fax to product manufacturers and to the NIAID
    Project Officer. The ICRPMC will transfer electronic monitoring
    device data to the CRPMC no less often than weekly.

i.  Deliver samples of items including product packaging containers,
    (e.g., bottles, vials, etc.), samples of new study products,
    monitoring devices, or supplies that have been identified as having
    problems to the NIAID Project Officer. The CRPMC may be requested to
    make same day deliveries of requested items. The ICRPMC will ship to
    the CRPMC Principal Investigator (PI) and follow the same process.

j.  Identify freight forwarders and couriers for shipments of study
    products that meet the needs of the study product based on
    destination, protection required for the study products, cost, and
    performance history.

k.  Perform end-of-study reconciliation of site accountability records,
    reconciling study products shipped with those used, returned, or
    destroyed for studies with public health impact as designated by the
    NIAID Project Officer.

l.  Emergency shipments or other extraordinary tasks may be required
    after normal hours of operation. Emergency shipments will be made at
    the request of the NIAID Project Officer. Shipments after normal
    working hours or on weekends should only be made in extreme
    circumstances. Except for emergency shipments or other extraordinary
    tasks, the CRPMC is required to be open and accessible during the
    hours of 8:30 AM to 5:00 PM Eastern Standard/Daylight Time, Monday
    through Friday, except for official United States Government
    holidays. The CRPMC is required to establish procedures for
    emergency closings due to weather conditions or other unexpected
    closings mandated by local, state and United States government
    authorities. The ICRPMC will be required to be open to meet the
    needs of the protocols being supported as directed by the CRPMC.

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6.  **SHIPPING DOCUMENTS AND REGULATIONS**

> The CRPMC and ICRPMC will:

a.  Generate and obtain all required shipping documents. Examples of
    required documents are: proforma invoices, letters of donation,
    Material Safety Data Sheets, CoAs, commercial invoices, and
    Certificate of Pharmaceutical Product.

b.  Research the regulations for shipment of study products into all
    countries where DAIDS-funded clinical research sites are located.

c.  Maintain a record in a database, created by the Contractor, of the
    regulations and documents required for shipment of study products to
    all countries with DAIDS-supported clinical research sites. This
    database is to be updated as needed and reviewed by the CRPMC at
    least every 6 months to ensure the information is current. The
    ICRPMC will provide information to the CRPMC for their region.

d.  Ensure that all required import and export documents are received
    from the clinical research site pharmacist, the broker retained by
    the clinical research site, the embassy of that country, the
    countries customs office or other pertinent office prior to
    processing the shipment to its destination. All documents for all
    shipments must be maintained on file for the life of the contract
    and will be transferred at the transition to the next contract. The
    ICRPMC will provide information and copies of documents for their
    region to the CRPMC on a quarterly basis.

e.  Ensure that the chosen courier service has the necessary expertise
    and collaborate with the courier service in providing assistance to
    international sites for obtaining necessary import, export, customs
    and tax exemption documents.

f.  Possess and maintain appropriate licenses and permits required by
    local, state, province, US, and country government authorities for
    the safe import, storage, handling, transportation, and distribution
    of drugs, biologics, controlled substances and devices. Process any
    document requiring embassy approval through the pertinent embassy.
    Obtain the appropriate interstate, intrastate and foreign
    import/export shipping licenses and permits for transporting drugs,
    biologics, controlled substances, and devices.

g.  The CRPMC will possess and maintain a current U.S. Drug Enforcement
    Agency license. The ICRPMC will maintain licenses and permits as
    required in the local jurisdiction for the storage and distribution
    of controlled substances.

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7.  **INVENTORY MANAGEMENT**

> The CRPMC and ICRPMC will:

a.  Perform a physical inventory of supplies for each protocol twice
    monthly, or more often as necessary. The ICRPMC will immediately
    notify the CRPMC of any discrepancies. The CRPMC will work with the
    ICRPMC to reconcile any discrepancies. The ICRPMC and the CRPMC will
    take the necessary actions to determine the cause of the
    discrepancy. The NIAID Project Officer will be notified in the
    Monthly Progress Report of any discrepancies that cannot be
    reconciled with the CPIMS.

b.  The CRPMC and the ICRPMC will perform ad hoc complete physical
    inventories or product-specific inventories.

c.  The CRPMC and the ICRPMC will monitor study product use rate at the
    CRPMC and the ICRPMC for low inventories or unusual increases in
    study product requests from PoRs. Changes in the use rate will be
    reported to the PI of the CRPMC. Changes in the study product use
    rate are to be reported weekly to the NIAID Project Officer during
    the regularly scheduled CRPMC/PAB meetings.

d.  Maintain, in a database at the CRPMC, a record of repass dates and
    expiration dates of all study products in inventory at the CRPMC and
    ICRPMC and of products shipped to PoRs. The database is required to
    be maintained on an ongoing basis to accommodate specific lead times
    for the reordering of supplies from multiple manufacturers. Reorder
    lead time must be sufficient to insure that study participants
    receive study products with adequate dating to last until their next
    study visit.

e.  Provide weekly hard copy reports of current inventory at the CRPMC
    and the ICRPMC to the NIAID Project Officer.

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8.  **cGMP, SANITATION AND ENVIRONMENTAL CONTROL**

> The CRPMC and the ICRPMC will:

a.  Ensure that the facility is maintained in a clean and sanitary
    condition, free of infestation by rodents, birds, insects, and other
    vermin.

b.  Develop and use procedures for handling and disposing of trash in a
    sanitary manner that prevents the development of unhygienic
    conditions due to infrequent trash pickups.

c.  Develop and implement SOPs for sanitation and use of pesticides to
    prevent contamination of all study products, packaging, labeling,
    containers and equipment. Rodenticides, insecticides, and fungicides
    may not be used unless registered and used in accordance with the
    Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135).

d.  Provide humidity controlled and monitored conditions for study
    products sensitive to low or high humidity.

e.  Protect study products sensitive to carbon dioxide or light.

f.  Meet all applicable Food and Drug Administration cGMP regulations,
    as specified in Title 21, Code of Federal Regulations (CFR), Parts
    210 and 211. The CFR can be found at:
    [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm.](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm)

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9.  **SECURITY AND SAFETY OF STUDY PRODUCTS**

> The CRPMC and the ICRPMC will:

a.  Provide up-to-date, 24-hour a day monitored, electronic security
    systems with real time notification of the CRPMC Principal
    Investigator (PI) or designee to prevent theft, misuse or damage to
    study products.

b.  Provide a recording electronic 24-hour a day temperature monitoring
    system to ensure the maintenance of appropriate temperature storage
    conditions (controlled room temperature, USP, refrigerators,
    freezers). If a failure to the primary system should occur, the
    system or service must continue to attempt to reach the CRPMC PI (or
    designee) until such contact has been made. All temperature records
    must be maintained for the life of the contract.

c.  Provide redundancy of equipment for maintaining storage conditions
    at ‑80°C, ‑20°C to ‑10°C, or 2°C to 8°C.

d.  Provide electric power generators with transfer switches between the
    electric utility and the power generator to insure automatic, safe,
    continuous and reliable source of power in the event of failure of
    electricity supplies.

e.  Provide a system to detect variances outside of the specified range
    such as cold storage, controlled room temperature, USP, and humidity
    controlled areas.

f.  Provide an Inergen® or equivalent clean agent fire suppression
    system that is environmentally acceptable and leaves no residues.

g.  Develop and implement, when necessary, a plan for the transfer of
    study products to appropriate storage conditions in the event of
    power failure, fire, flood, or other occurrences capable of damaging
    study products.

h.  Meet the requirements of the U.S. Drug Enforcement Agency and
    in-country requirements for secure storage of controlled substances.

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10. **INTERNAL TRAINING OF CRPMC AND ICRPMC STAFF**

    a.  Provide and document training for CRPMC and ICRPMC employees
        regarding safety measures for study products.

    b.  Provide and document annual training for facility security, fire
        drills, fire suppression system, cGMP, dry ice handling,
        personal protection and protection equipment (for those
        involved), employee-monitoring-systems for use in walk in
        freezers, and chemical spill clean-up procedures for all
        personnel with access to the CRPMC and the ICRPMC.

    c.  Provide training for CRPMC and ICRPMC employees in the proper
        packing and use of validated shipping containers, on the use of
        standard forms and templates for letters and memoranda, and
        record keeping practices.

    d.  Require all CRPMC and ICRPMC pharmacists and pharmacy
        technicians to read and be familiar with the DAIDS Pharmacy
        Guidelines and Instructions for DAIDS Clinical Trials Networks,
        Network Standard Operating Procedure Webpages, and PAB SOPs.

    e.  All CRPMC and ICRPMC pharmacists and any staff needing to follow
        any new SOP are required to review and document that review by
        signature to verify that the review occurred.

    f.  Provide training to CRPMC and ICRPMC employees in the use of
        computer systems for databases.

    g.  Provide trained staff that is certified for shipment of
        dangerous goods at the CRPMC and the ICRPMC.

    h.  Provide staff trained in the use of a commercially available
        software system that projects quantity of study products
        required at the CRPMC.

> i\. Hold weekly internal meetings of CRPMC pharmacists and technicians
> to:

1.  review new and revised SOPs

2.  review established SOPs when breaches in procedures have occurred

3.  inform staff of protocol-specific issues

4.  cross-train employees for prevention of impeded work flow

5.  brief staff on current issues.

6.  Include minutes of weekly internal meetings in the Monthly Progress
    Reports.

> j\. The ICRPMC employees will meet weekly to discuss issues that need
> to be brought to the attention of the CRPMC PI.
>
> k\. Each CRPMC pharmacist is required to spend two days for one time
> only under the life of this contract at the DAIDS for orientation to
> the work of the PAB.
>
> l\. In accordance with the NIH Policy Manual, Issuance 1160-1 --
> Entertainment, dated August 31, 2000, light refreshments and meals may
> not be provided for training sessions as a direct charge to the
> contract.

11. **FINAL DISPOSITION OF STUDY PRODUCTS**

    a.  Identify lot numbers of study products and notify the PoR and
        the NIAID Project Officer when study products are to be returned
        to the CRPMC and the ICRPMC in the event that:

-   a study product lot number is recalled by the manufacturer

-   a study product lot number is recalled by the DAIDS

-   study treatment using the product has ended

-   study product has reached the expiration date

-   the cold chain requirements were breached

-   study product has reached the useful shelf life limit

    a.  Any request by the CRPMC and the ICRPMC to the clinical research
        site for study product returns must indicate all applicable
        special handling instructions (i.e., in the case of dangerous
        goods). All requests must include a complete list of protocols
        used for that study product lot.

    b.  Remove active stock at the CRPMC and ICRPMC to quarantine when
        study products have been recalled or are no longer to be shipped
        to clinical research sites.

    c.  Provide quarantine space at the CRPMC and the ICRPMC for items
        no longer needed for the clinical trial until final disposition
        at the appropriate storage condition temperatures (i.e.,-80°C,
        -20°C, 2°C to 8°C, controlled room temperature, USP).

    d.  Receive recalled, expired or unused study products returned from
        site PoRs. Process returns in compliance with local, state and
        US regulations. Returned and expired products must be
        quarantined from other inventory at the CRPMC and ICRPMC.

    e.  Prepare and maintain computerized documentation of all study
        product returns to the CRPMC and ICRPMC. Provide an original
        receipt to the PoR within 10 business days of receipt of return.

    f.  Dispose of returned products in accordance with local, state,
        province, and United States Government regulations. This may
        require destruction or return of the drug to the manufacturer.

    g.  The CRPMC will obtain and maintain documentation of the final
        study product disposition from all ICRPMCs and clinical research
        sites.

    h.  The CRPMC and ICRPMC must establish an onsite final disposition
        program that meets all United States and local public and
        occupational health, safety and environmental protection
        regulations.

12. **DATA MANAGEMENT**

> a\. Meet NIH Information Security requirements. Comply with Automated
> Information Systems Security Program of DHHS located at
> <http://wwwoirm.nih.gov/policy/aissp.html>. Develop an Information
> Security plan and submit it to the NIAID PO for NIAID approval 45 days
> before work under this contract commences.

Information Security consists of:

> i\. Confidentiality: the prevention of unauthorized disclosure/use of
> information.
>
> ii\. Integrity: the prevention of unauthorized modifications to
> information.
>
> iii\. Availability: ensuring the reliable and timely access to data or
> computing resources.
>
> The Information Security plan will address the physical and electronic
> security for all information, data and communications including
> hardware, software and paper files. Implement and maintain security
> requirements for the computer system used for data management to:

i.  Provide security against anticipated risks including viral or
    catastrophic loss of data or important software.

ii. Apply all patches immediately.

iii. Test back-up systems for functionality and describe frequency of
     testing.

iv. Provide security in the event of a national emergency.

> b\. Provide hardware and software needed to run the existing CRPMC
> Oracle Based Clinical Products Inventory Management System (CPIMS).
>
> c\. Maintain CPIMS to keep inventories and distribution records to
> track and assist in the coordination of activities under this
> contract.
>
> d\. Provide validation processes to ensure the integrity of data in
> CPIMS.
>
> e\. Perform database server back-ups a minimum of five times per week.
>
> f\. DAIDS is currently implementing a comprehensive information
> system, the DAIDS Enterprise System (DAIDS-ES), to support its
> business functions, management, and oversight responsibilities. The
> CRPMC will be required to provide the necessary staff and resources to
> work with DAIDS and its contractors as standards and reporting
> requirements are developed. A memorandum of agreement will be
> established between DAIDS and the owners/providers of
> applications/systems that share data/information with the DAIDS-ES.
>
> g\. Maintain a system in which personal computers used in a local area
> network are designed to interface with each ther and have the
> capability to communicate electronically to access, receive, upload
> and/or download specific data from databases maintained by DAIDS
> contractors for regulatory compliance and clinical research site
> monitoring.
>
> h\. All requests for study products received from PoRs and approved
> and authorized by the CRPMC are required to be entered into the CRPMC
> database on a daily basis.
>
> i\. Maintain inventory-related computer files and reports that include
> the following fields:

-   Authorized Investigator Files

-   Manufacturer Files

-   Study Product

-   Strength, Unit, and Formulation Files

-   Protocol Number Files

-   NSC Number Files

-   Daily Shipment Files

-   Yearly Shipment Files

-   Lot Summary Files

-   Return Drug Files

-   Quarantine Drug Files

-   Site Distribution Files

-   Expiration Date Files

-   Inventory Files

-   Other files as necessary

> j\. Integrate ICRPMC(s) data pertaining to study product receipt,
> storage, distribution, and final disposition in real time into CPIMS.
> The CRPMC must be able to produce integrated reports as well as those
> that separate inventory information by distribution center.
>
> k\. Input and maintain data into CPIMS from DAIDS-funded regulatory
> contractors. The CRPMC shall interact with other NIAID contractors for
> the purpose of exchanging data, or downloading or transfering data to
> other DAIDS or DAIDS-supported software systems.
>
> l\. Input and maintain site pharmacist-related computer files into the
> CRPMC PoR database and reports. PoR files should include:

-   name

-   mailing address

-   shipping address

-   phone number

-   fax number

-   e-mail address

-   study site number(s)

> m\. Input clinical site pharmacy monitoring data into a CRPMC
> generated database and maintain clinical site pharmacy site monitoring
> related computer files and reports that include:

-   Study Site Number

-   Study Site Name

-   Protocol Network

-   Inspection Type/Monitor

-   Inspection Date

-   Study Site Monitoring Summary Report

-   Quarterly Report summarizing critical issues at the study sites

-   Protocol Specific Pending Issues Report, as required

> n\. Input into a spreadsheet to be able to generate and maintain
> Weekly Protocol Reports that include:

-   Protocol Number

-   Version number

-   DAIDS Protocol Pharmacist

-   CRPMC Pharmacists

-   Drugs

-   Manufacturers

-   Inventory status

-   Status of negotiations with the product manufacturers

-   Supply Comments

-   Date of written communications with product manufacturers

-   Action Items

-   Additional comments.

> o\. Maintain secure Internet access and a technically reliable and
> capable software communications program to send and receive electronic
> mail messages and exchange documents with DAIDS and its contractors.
>
> p\. Utilize current technology to protect against computer viruses,
> spam, ad-ware, worms and other intrusions through the Internet.
>
> q\. Maintain DAIDS compatible, technically capable hardware, and
> Microsoft compatible software (i.e., Microsoft Word, Mircosoft
> PowerPoint, Microsoft Office Project, AdobeAcrobat Professional)
> needed to scan and/or prepare documents for DAIDS and its contractors.
>
> r\. To achieve compatibility and accessibility of data, DAIDS and its
> support contractor(s) will provide data exchange guidelines and a set
> of platform technology standards. The Contractor must adhere to these
> guidelines and standards on a continual basis. This may include the
> need for the Contractor to utilize DAIDS-supplied software components
> or use eXtensible Markup Language (XML) schemas in applications, where
> needed, to affect specific types of transactions, Graphical User
> Interface (GUI) and other software-based tasks that interact with the
> DAIDS-ES.
>
> s\. In the event that the contractor proposes to develop any software,
> the plans must be submitted to the NIAID CO for review and approval.
>
> t\. The Contractor shall provide to the Government all software, OS's,
> languages, and tools developed as part of the contract, or if
> Commercial-off-the-shelf (COTS) products were purchased under the
> contract all such products shall be transferred to the government and
> must be removed from all contractor owned equipment.
>
> u\. Management tools, computer systems, databases, documentation,
> data, and any other electronic files or items developed via this
> contract will remain the property of the U.S. Government.
>
> 14\. **ADMINISTRATIVE SUPPORT**

a.  Provide trained personnel designated to develop and maintain the
    record of all CRPMC SOPs.

b.  Develop and use standardized templates for documents, memorandums
    and letters.

c.  Maintain electronic or paper copies as received of all
    communications.

d.  Provide the storage in archival quality of shipping reports,
    documents, etc., related to study product distribution. Retain all
    original study product request forms for the duration of the
    contract.

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15. **PURCHASING STUDY PRODUCTS**

> In the event a study product cannot be obtained by donation, the CRPMC
> may purchase drugs or other products required for the implementation
> of DAIDS-supported clinical trials. This purchase must be in
> accordance with NIAID policies and may require interaction and
> coordination with the DAIDS-funded Clinical Trials Network COREs if
> funds for purchasing study products are provided by the networks or
> outside sources.

16. **MANAGEMENT AND OVERSIGHT OF THE ICRPMCs**.

> The CRPMC will:
>
> a\. Provide oversight of all the activities of the ICRPMC.
>
> b\. Visit the ICRPMC to evaluate capabilities before finalizing the
> sub-contract, during the performance period and for cause.
>
> c\. Provide fiscal oversight of the ICRPMC.
>
> d\. Ensure that the ICRPMC SOPs are in accordance with those of the
> CRPMC.
>
> e\. Ascertain the ICRPMC\'s compliance with the ICRPMC's SOPs.
>
> f\. Ensure that the ICRPMC maintains protocol specific files.
>
> g\. Review the training records of the ICRPMC.

17. **FINAL TRANSITION (CONTRACT COMPLETION)**

    a.  A **[Draft Final Transition Plan]{.underline}** is to be
        submitted to the NIAID Project Officer and the NIAID Contracting
        Officer 12 months prior to the completion date of the contract
        for review and approval.

    b.  The **[Final Transition Plan]{.underline}** that incorporates
        all agreed to terms and conditions identified during the review
        of the Draft Plan, will be submitted to the NIAID Project
        Officer and NIAID Contracting Officer 10 months prior to the
        completion date of the contract. The Contractor will implement
        the transition plan during the contract's period of performance.

    c.  Both Transition Plans will address the following:

        1.  Providing for the safe and efficient assumption of
            activities from this contract to a successor contractor or
            to the Government.

        2.  Maintaining the functions of the CRPMC during any transition
            period, specifically distribution of the study products for
            DAIDS-funded clinical trials without interruption at any
            time.

        3.  Ensuring a seamless transition without loss of time, loss of
            products or that would not pose obstacles to the conduct of
            on-going clinical trials, including any training time
            associated with the transfer and continued operation of the
            current CRPMC.

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        4.  Implementing the Transition Plan, including the tasks that
            are associated with the relocation effort from the current
            contractor and the manner of operations required by the
            NIAID PO during the transisiton period. This should include
            the effective coordination with the current contractor at
            the start of the new contract period for safe transfer of
            contract-related materials including:

            a.  Study product inventory

            b.  Inventory records

            c.  Correspondence files with product manufacturers,
                clinical research sites, and DAIDS

            d.  Shipping records

            e.  Databases, software systems and other software

            f.  Government-furnished property

            g.  Shipping materials, cartons, labels, packing materials

            h.  Validated shipping procedures

            i.  NIAID approval documents

            j.  CoAs and any other items requiring maintainance by the
                CRPMC for the duration of the contract

        5.  In the event of a transition to a successor contractor, the
            current CRPMC will provide to the new contractor (or to the
            Government) the existing Oracle data base management system
            of the CRPMC, CPIMS, and necessary documentation of the
            activities of the CRPMC. A major component of the system is
            the module to track individual investigators' product
            requests. Other modules support production of standard
            reports, such as receiving and shipping. More specialized
            reports including inventory by product and by study
            protocol, list of clinical research sites and pharmacists of
            record must also be made available. The CRPMC computer files
            must be transferred.

[]{.mark}

**\[END OF STATEMENT OF WORK\]**

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

[Acronyms]{.underline}:

CFR Code of Federal Regulations

cGMP Current Good Manufacturing Practices

CoA Certificate of Analysis

COREs Coordinating and Operations Centers

CPIMS Clinical Products Inventory Management System

CRPMC Clinical Research Products Management Center

CSMC Clinical Site Monitoring Contractor

FDA U.S. Food and Drug Administration

ICRPMC Internation Clinical Research Products Management Center

PAB Pharmaceutical Affairs Branch

PI Principal Investigator

PoR Pharmacist of Record

QA Quality Assurance

QAC Quality Assurance Committee

SDMC Statistical and Data Management Center

SOPs Standard Operating Procedures

USP United States Pharmacopoeia

[]{#D .anchor}**REPORTING REQUIREMENTS and OTHER DELIVERABLES**

In addition to those reports required by the other terms of this
contract, the Contractor is required to prepare and submit the following
reports in the manner stated below and in accordance with ARTICLE F.1.,
DELIVERIES, of this contract.

These reports are to be factual and are required to contain a cover page
prepared in accordance with the following format:

-   Contract Number and Project Title

-   Period of Performance Being Reported

-   Contractor\'s Name and Address

-   Author(s)

-   Date of Submission

-   Delivery Address

A.  **[Weekly Protocol Reports]{.underline}**: Prepare Weekly Protocol
    Reports for the weekly meeting with the NIAID Project Officer and
    PAB staff. Provide a hard copy to each PAB Pharmacist at the
    beginning of the meeting.

    1.  The report is to include the following categories of protocols:

        a.  All protocols in development.

        b.  Protocols identified by PAB that require close monitoring.

        c.  Protocols on hold.

    2.  For each protocol listed on the Weekly Protocol Report the
        following information is to be provided:

        a.  Protocol number/name.

        b.  Version of protocol at the CRPMC.

        c.  PAB pharmacist assigned to the protocol.

        d.  CRPMC pharmacist assigned to the protocol.

        e.  List of study agents and associated manufacturers.

        f.  Status of shipments.

        g.  Status of letters of request to the manufacturers for each
            study agent used in each protocol.

        h.  Action items for each protocol.

B.  **[Weekly Inventory Reports]{.underline}***:* Submit an electronic
    copy of the inventory report to the NIAID PO each week. The report
    is due by close of business on the Friday of each week and will list
    the inventory of all study products including:

-   drug name

-   drug strength

-   dosage form

-   unit of issue

-   lot number

-   manufacturer

    -   quantity received

    -   inventory balance

    -   expiration date

    -   storage location

    -   protocol number.

C.  **[Monthly Progress Reports]{.underline}**: Submit two copies of a
    Monthly Progress Report, one to the NIAID Project Officer and one to
    the NIAID Contracting Officer covering the work accomplished during
    the preceding month. The first report shall include the first full
    month of the contract including any fractional part of the initial
    month and is due on/before the 15^th^ of the month following each
    reporting period. The Report must include:

    a.  Introduction: A section covering the purpose and scope of the
        contract effort.

    b.  Progress report: A section describing overall progress for each
        task or segment of work listed in the Statement of Work on which
        effort was expended during the reporting period.

    c.  Personnel changes: A section covering any changes in personnel
        or in level of effort of CRPMC staff.

    d.  Problems and solutions: A section describing technical or
        performance problems encountered and corrective action taken. An
        explanation of any differences between planned and actual
        progress shall be included.

    e.  Financial report: A section describing the financial status of
        the contract

    f.  Maintenance of facilities, inventory, supplies and equipment: A
        section describing problems encountered and corrective action
        taken since the last monthly report.

    g.  Minutes of the Weekly CRPMC Internal Meeting.

D.  **[Annual Reports]{.underline}**: Submit two copies of the Annual
    Reports, one to the NIAID PO and one to the Contracting Officer that
    document and summarize the results of the contract work for the
    period covered and should cover Sections A-F above. The Annual
    Report will cover each 12-month period of performance beginning with
    the effective date of the contract and will be due on/before the
    30^th^ of the month following each anniversary date of the contract.
    The summary should be 40-59 pages in length. An Annual Report will
    not be required when the Final Report is submitted.

E.  **[Final Report and Summary of Salient Results]{.underline}**: The
    Final Report will cover the entire contract performance period and
    be in sufficient detail to explain comprehensively the accomplished
    tasks, a brief description of any unfinished projects, and a status
    report on transition or shut down activities. In addition, the
    Contractor will provide a 250 word "Summary of Salient Results"
    detailing the important accomplishments from the contract studies
    during the performance of the contract. The Final Report is due on
    or before the completion date of the contract.

F.  **[Other Deliverables]{.underline}**: The following deliverables are
    to be prepared and delivered as noted in the Statement of Work:

-   Protocol Evaluations \[SOW Para. 2.a.2.)\]

-   Protocol-Specific Documents \[SOW Para. 2.a.4)\]

-   Evaluations of Study Product Usage and Projections \[SOW Para.
    2.b.\]

-   CoA Documentation Forms with study product manufacturer's CoA \[SOW
    Para. 2.e.\]

-   Quarterly Recommendations for Pharmacy Site Monitoring \[SOW Para.
    2.f.1)f)\]

-   Pharmacy Site Visit Reports for CRPMC conducted site visits \[SOW
    Para. 2.g.1)\]

-   Site Pharmacy Guidance Activities Summary \[SOW Para. 2.g.3)\]

-   Site Pharmacy Changes \[SOW Para. 2.g.5)\]

-   cGMP Audit Report of Study Product Manufacturing Facilities \[SOW
    Para. 2.h.\]

-   Label samples \[SOW Para. 4.e.\]

-   Repackaged study product samples \[SOW Para. 4.f.\]

-   Packaging and Shipping Study Product Validation Testing SOPs \[SOW
    Para. 5.b.\]

-   Transfer electronic monitoring device data to CRPMC \[SOW Para.
    6.h.\]

-   Shipping regulations and documents \[SOW Para. 7.d.\]

G.  **[Report Distribution]{.underline}**

+--------------+-----------+------------------+-----------------------+
| **Report/D   | *         | **No. of         | **Due Date**          |
| eliverable** | *Contract | Copies**         |                       |
|              | Cite**    |                  |                       |
+--------------+-----------+------------------+-----------------------+
| **REPORTS**  |           |                  |                       |
+--------------+-----------+------------------+-----------------------+
| Weekly       | ART. C.2. | 1 copy to each   | To be distributed at  |
| Protocol     |           | attendee of the  | the meeting at the    |
| Reports      |           | weekly DAIDS,    | beginning of each     |
|              |           | PAB/CRPMC        | meeting.              |
|              |           | meeting.         |                       |
+--------------+-----------+------------------+-----------------------+
| Weekly       | ART. C.2. | 1 electronic     | Due by close of       |
| Inventory    |           | copy to PO.      | business on the       |
| Report       |           |                  | Friday of each week.  |
+--------------+-----------+------------------+-----------------------+
| Monthly      | ART. C.2. | 1 original to CO | Due on/before the     |
| Progress     |           |                  | 15^th^ of the month   |
| Report       |           | 1 copy to PO     | following each        |
|              |           |                  | monthly reporting     |
|              |           |                  | period.               |
+--------------+-----------+------------------+-----------------------+

+--------------+-----------+------------------+-----------------------+
| Annual       | ART. C.2. | 1 original to CO | Due on/before the     |
| Report       |           |                  | 30^th^ of the month   |
|              |           | 1 copy to PO     | following each        |
|              |           |                  | anniversary date of   |
|              |           |                  | the contract. Not due |
|              |           |                  | when the Final Report |
|              |           |                  | is due.               |
+--------------+-----------+------------------+-----------------------+
| Draft        | SOW,      | 1 original to CO | Due 12 months prior   |
| Transition   | para.     |                  | to the completion     |
| Plan         | 17.a.     | 1 copy to PO     | date of the contract. |
+--------------+-----------+------------------+-----------------------+
| Final        | ART. C.2. | 1 original to CO | Due 10 months prior   |
| Transition   |           |                  | to the completion     |
| Plan         |           | 1 copy to PO     | date of the contract. |
+--------------+-----------+------------------+-----------------------+
| Final Report | ART. C.2. | 1 original to CO | Due on/before the     |
| and Summary  |           |                  | completion date of    |
| of Salient   |           | 1 copy to PO     | the contract.         |
| Results      |           |                  |                       |
+--------------+-----------+------------------+-----------------------+
| **OTHER      |           |                  |                       |
| DE           |           |                  |                       |
| LIVERABLES** |           |                  |                       |
+--------------+-----------+------------------+-----------------------+
| Protocol     | SOW,      | 1 electronic     | Due within 5 business |
| Evaluations  | Para.     | copy to PO       | days of receipt of    |
|              | 2.a.2)    |                  | protocol draft.       |
|              |           | 1 electronic     |                       |
|              |           | copy to PAB      |                       |
|              |           | pharmacist on    |                       |
|              |           | the protocol     |                       |
|              |           | team             |                       |
+--------------+-----------+------------------+-----------------------+
| Protocol     | SOW,      | 1 electronic     | 24 hours after        |
| Specific     | Para.     | copy to PAB      | receipt of all study  |
| Documents    | 2.a.4)    | pharmacist on    | products for that     |
|              |           | the protocol     | protocol              |
|              |           | team             |                       |
+--------------+-----------+------------------+-----------------------+
| Evalaution   | SOW,      | 1 electronic     | Copy to PO due prior  |
| of Study     | Para.     | copy to PO       | to submitting to      |
| Product      | 2.b.      |                  | product manufacturer. |
| Usage and    |           | 1 electronic     |                       |
| Projections  |           | copy to product  | Copy to product       |
|              |           | manufacturers    | manufacturer due on a |
|              |           |                  | case-by-case basis as |
|              |           |                  | required by product   |
|              |           |                  | manufacturer.         |
+--------------+-----------+------------------+-----------------------+
| CoA          | SOW,      | 1 hard copy to   | Due the day after     |
| D            | Para.     | PO               | receipt of CoA        |
| ocumentation | 2.e.      |                  |                       |
| Form         |           |                  |                       |
+--------------+-----------+------------------+-----------------------+
| Quarterly    | SOW,      | 1 electronic     | Due Quarterly on:     |
| Reco         | Para.     | copy to PO and   | Feb. 10^th^, May      |
| mmen-dations | 2.f.1)f)  | each PAB         | 10^th^, August        |
| for Site     |           | pharmacist       | 10^th^, Nov. 10th     |
| Monitoring   |           |                  |                       |
| and Site     |           |                  |                       |
| Pharmacy     |           |                  |                       |
| Changes      |           |                  |                       |
+--------------+-----------+------------------+-----------------------+
| Pharmacy     | SOW,      | 1 electronic     | Due 10 business days  |
| Site Visit   | Para.     | copy to PO       | after completion of   |
| Reports for  | 2.g.1)    |                  | site visit            |
| CRPMC        |           |                  |                       |
| Conducted    |           |                  |                       |
| Site Visits  |           |                  |                       |
+--------------+-----------+------------------+-----------------------+
| Site         | SOW,      | 1 electronic     | Due 10 business days  |
| Pharmacy     | Para.     | copy to PO       | after completion of   |
| Guidance     | 2.g.3)    |                  | training activities.  |
| Activities   |           |                  |                       |
| Summary      |           |                  |                       |
+--------------+-----------+------------------+-----------------------+
| Site         | SOW,      | 1 copy to PO     | Due Quarterly on:     |
| Pharmacy     | Para.     |                  | Feb. 10^th^, May      |
| Changes      | 2.g.5)    |                  | 10^th^, August        |
|              |           |                  | 10^th^, Nov. 10th     |
+--------------+-----------+------------------+-----------------------+
| cGMP Audits  | SOW,      | 1 hard copy to   | Due 15 business days  |
|              | Para.     | PO               | after completion of   |
|              | 2.h.      |                  | audit                 |
|              |           | 1 electronic     |                       |
|              |           | copy to PO       |                       |
+--------------+-----------+------------------+-----------------------+
| Label        | SOW,      | 1 hard copy to   | Same day generated or |
| Samples      | Para.     | PO               | the day after it is   |
|              | 4.e.      |                  | generated             |
+--------------+-----------+------------------+-----------------------+
| Repackaged   | SOW,      | 1 package of     | As soon as a sample   |
| Study        | Para.     | each product     | study product is      |
| Product      | 4.f.      | to PO            | generated and prior   |
| Samples      |           |                  | to completion of the  |
|              |           |                  | task                  |
+--------------+-----------+------------------+-----------------------+
| Validation   | SOW,      | 1 hard copy to   | 3 weeks after         |
| Testing SOPs | para.     | PO               | completion of         |
|              | 5.b.      |                  | validation testing    |
|              |           | 1 hard copy for  |                       |
|              |           | SOP manual       |                       |
+--------------+-----------+------------------+-----------------------+
| Transfer of  | SOW,      | 1 electronic     | Weekly                |
| electronic   | para.     | copy to CRPMC    |                       |
| monitoring   | 6.h.      |                  |                       |
| device data  |           |                  |                       |
| from ICRPMC  |           |                  |                       |
+--------------+-----------+------------------+-----------------------+
| Shipping     | SOW,      | 1 copy to the    | Due Quarterly on:     |
| Regulations  | para.     | CRPMC            | Feb. 10^th^, May      |
| and          | 7.d.      |                  | 10^th^, August        |
| Documents    |           |                  | 10^th^, Nov. 10th     |
+--------------+-----------+------------------+-----------------------+

**H. [Addresses]{.underline}**

Project Officer: National Institutes of Health, DHHS

National Institute of Allergy and Infectious Diseases

Division of AIDS, PAB

6700-B Rockledge Drive

Bethesda, MD 20892-7620

Contracting Officer: National Institutes of Health, DHHS

National Institute of Allergy and Infectious Diseases

Contract Management Program, DEA 6700-B Rockledge Drive, Room 3214, MSC
7612

Bethesda, MD 20892-7612

# PART I - THE SCHEDULE

## SECTIONS B - H \-- UNIFORM CONTRACT FORMAT - GENERAL

A Sample Uniform Contract Format may be found at the following website:

<http://rcb.cancer.gov/rcb-internet/wkf/sample-contract.htm>

# PART II -- CONTRACT CLAUSES

## SECTION I - CONTRACT CLAUSES

[]{#F .anchor}

THE FOLLOWING PAGES CONTAIN A LISTING(S) OF GENERAL CLAUSES WHICH WILL
BE APPLICABLE TO MOST CONTRACTS RESULTING FROM THIS RFP. HOWEVER, THE
ORGANIZATIONAL STRUCTURE OF THE SUCCESSFUL OFFEROR(S) WILL DETERMINE THE
SPECIFIC GENERAL CLAUSES LISTING TO BE CONTAINED IN THE CONTRACT(S)
AWARDED FROM THIS RFP.

[]{#G .anchor}**ARTICLE I.1. GENERAL CLAUSES**

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

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

**General Clauses for a Cost-Reimbursement Research and Development
Contract**

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

**ITEM 4: Alternate IV** (OCTOBER 1997) of FAR Clause 52.215-21,
**Requirements for Cost or Pricing Data of Information Other Than Cost
Or Pricing Data---Modifications** (OCTOBER 1997) is added.

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

### 

### ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES

**ITEM 39:** FAR Clause **52.219-25, Small Disadvantaged Business
Participation Program---Disadvantaged Status and Reporting** (OCTOBER
1999), is applicable to this solicitation.

**ITEM 59:** FAR Clause **52.237-3, Continuity of Services** (JANUARY
1991), is applicable to this solicitation.

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

No additional or supplemental Additional FAR Contract Clauses Included
in Full Text are applicable to this solicitation. See **I.4. Additional
FAR Contract Clauses Included in Full Text** of SECTION I at
<http://rcb.cancer.gov/rcb-internet/wkf/sectioni.pdf> for the general
listing of Additional FAR Contract Clauses Included in Full Text.

# PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

## SECTION J - LIST OF ATTACHMENTS

[]{#K .anchor}

The following Attachments are provided in full text with this
Solicitation:

[PACKAGING AND DELIVERY OF
PROPOSALS](http://www.niaid.nih.gov/contract/eproposal.htm#pack):
(http://www.niaid.nih.gov/contract/eproposal.htm#pack)

[HOW TO PREPARE AN ELECTRONIC
PROPOSAL](http://www.niaid.nih.gov/contract/eproposal.htm#electronic):
(http://www.niaid.nih.gov/contract/eproposal.htm#electronic)

[PROPOSAL INTENT RESPONSE SHEET \[SUBMIT ON/BEFORE](#l): [APRIL 23, 2005
\]]{.underline} (Attached to this listing)

> \[NOTE: Your attention is directed to the \"Proposal Intent Response
> Sheet\". If you intend to submit a proposal, you must complete this
> form and return it to this office via fax or e-mail on or before the
> date identified above. The receipt of this form is critical as it
> contains information essential for CMP's coordination of the
> electronic submission and review of proposals.\]
>
> **RFP FORMS AND ATTACHMENTS:**
>
> THE RFP FORMS/ATTACHMENTS LISTED BELOW ARE AVAILABLE IN A VARIETY OF
> FORMATS AND MAY BE VIEWED OR DOWNLOADED DIRECTLY FROM THIS SITE:

<http://www.niaid.nih.gov/contract/ref.htm>

APPLICABLE TO TECHNICAL PROPOSAL (INCLUDE THESE DOCUMENTS/FORMS WITH
YOUR TECHNICAL PROPOSAL):

### Technical Proposal Cover Sheet {#technical-proposal-cover-sheet .Normal-Bold-(bullet)}

### NIH-1688-1, Project Objectives {#nih-1688-1-project-objectives .Normal-Bold-(bullet)}

### Technical Proposal Cost Information {#technical-proposal-cost-information .Normal-Bold-(bullet)}

### Summary of Related Activities {#summary-of-related-activities .Normal-Bold-(bullet)}

### Government Notice for Handling Proposals {#government-notice-for-handling-proposals .Normal-Bold-(bullet)}

APPLICABLE TO BUSINESS PROPOSAL (INCLUDE WITH YOUR BUSINESS PROPOSAL):

### NIH-2043, Proposal Summary and Data Record {#nih-2043-proposal-summary-and-data-record .Normal-Bold-(bullet)}

### Small Business Subcontracting Plan Format  {#small-business-subcontracting-plan-format .Normal-Bold-(bullet)}

### Breakdown of Proposed Estimated Cost (plus fee) and Labor Hours {#breakdown-of-proposed-estimated-cost-plus-fee-and-labor-hours .Normal-Bold-(bullet)}

### Offeror's Points of Contact  {#offerors-points-of-contact .Normal-Bold-(bullet)}

TO BECOME CONTRACT ATTACHMENTS (INFORMATION ONLY):

### NIH(RC)-4: Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts {#nihrc-4-invoicefinancing-request-and-contract-financial-reporting-instructions-for-nih-cost-reimbursement-type-contracts .Normal-Bold-(bullet)}

### NIH(RC)-7: Procurement of Certain Equipment, (OMB Bulletin 81-16) {#nihrc-7-procurement-of-certain-equipment-omb-bulletin-81-16 .Normal-Bold-(bullet)}

### Safety and Health, HHSAR Clause 352.223-70 {#safety-and-health-hhsar-clause-352.223-70 .Normal-Bold-(bullet)}

### Report of Government Owned, Contractor Held Property {#report-of-government-owned-contractor-held-property .Normal-Bold-(bullet)}

### Government Property Schedule {#government-property-schedule .Normal-Bold-(bullet)}

### Disclosure of Lobbying Activities, OMB Form LLL  {#disclosure-of-lobbying-activities-omb-form-lll .Normal-Bold-(bullet)}

> []{#l .anchor}**PROPOSAL INTENT RESPONSE SHEET**
>
> **RFP No.:** NIH-NIAID-DAIDS-06-05
>
> **RFP Title:** "Clinical Research Products Management Center (CRPMC)"
>
> Please review the attached Request for Proposal. Furnish the
> information requested below and return this page by
>
> [April 23, 2005]{.underline}. Your expression of intent is not binding
> but will greatly assist us in planning for proposal evaluation.
>
> **Since your proposal will also be submitted electronically, please
> include the name and e-mail of the individual to whom the electronic
> proposal instructions, login code, and password should be provided.**
>
> \[ \] 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:
>
> CMP, NIAID, NIH
>
> Room 3214
>
> 6700-B Rockledge Drive, MSC 7612
>
> Bethesda, MD 20892-7612
>
> Attn: Dominic Reeves
>
> RFP-NIH-NIAID-DAIDS-06-05
>
> FAX: (301) 402-0972
>
> Email : <dreeves@niaid.nih.gov>

###   {#section-3 .Normal-Bold-(bullet) .unnumbered}

# PART IV -- REPRESENTATIONS AND INSTRUCTIONS

## SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

Representations, Certifications, and Other Statements of Offerors or
Quoters (Negotiated).

1.  REPRESENTATIONS AND CERTIFICATIONS

Federal Acquisition Circular (FAC 2001-26), published on December 20,
2004, implements the ***Online Representations and Certifications
Application (ORCA)*** effective on January 1, 2005. The ORCA became a
Federal mandate as published in the Federal Acquisition Circular
2001-26, FAR case 2002-024, and now requires the use of ORCA in Federal
solicitations as a part of the proposal submission process.

To comply with this requirement and to register in ORCA, you will need
to have two items: an active Central Contractor Registration (CCR)
record and a Marketing Partner Identification Number (MPIN) identified
in that CCR record. Your DUNS number and MPIN act as your company's ID
and password into ORCA. (Visit [www.ccr.gov](http://www.ccr.gov/) for
more information on creating and entering your MPIN). The basic
information provided in your CCR record is used to pre-populate a number
of fields in ORCA. Vendors are reminded to protect their MPIN from
unauthorized use. Once in ORCA you will be asked to review pertinent
information pre-populated from CCR, provide a point of contact, and
answer a questionnaire that contains up to 26 questions. The
questionnaire is to help you gather information you need for the
clauses. The questionnaire is not the official version. Be sure to read
the provisions carefully.

The answers you provide are then automatically entered into the actual
FAR provisions. You are required to review your information, as
inserted, in context of the full-text provisions for accuracy;
acknowledge three additional read-only provisions; and click a time/date
stamp before final submission. You will need to review and/or update
your ORCA record when necessary, but at least annually in order to
maintain its active status. Detailed information regarding ORCA, how to
submit your record, and whom to call for assistance can be found on
ORCA's homepage at [http://orca.bpn.gov](http://orca.bpn.gov/) under
"Help." The ORCA site contains an ORCA Application Handbook and an ORCA
Quick Reference Guide.  To access them, simply click on the \"Help\"
link at the top of the ORCA homepage.

The Representations and Certifications required by this particular
acquisition can be accessed electronically from the INTERNET at the
following address:

<http://rcb.cancer.gov/rcb-internet/wkf/sectionk.pdf>

## SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

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

[]{#O .anchor}**I. GENERAL INFORMATION**

ITEM 2: Alternate I, of FAR Clause 52.215-1, INSTRUCTIONS TO
OFFERORS-COMPETITIVE ACQUISTION, is applicable to this solicitation.

ITEM 9: 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 NAICS Code is 541710.

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

ITEM 10: THIS REQUIREMENT IS NOT SET ASIDE FOR SMALL BUSINESS is
applicable to this solicitation.

ITEM 11: 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/about February 28, 2006.

It is anticipated that the award from this solicitation will be a
multiple-year COST REIMBURSEMENT COMPLETION type contract with a Period
of Performance of 7 years, and that incremental funding will be used
\[see Section L, PART IV - Business Proposal Instructions\].

ITEM 13: 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 effort to be approximately 14.39 FTEs using
1880 hours as a base. This information is furnished for the offeror's
information only and is not to be considered restrictive for proposal
purposes.

ITEM 16: 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]{.underline}. The relative importance of the evaluation
factors is 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.

ITEM 20: LATE PROPOSALS AND REVISIONS, HHSAR 352.215-70, is applicable
to this solicitation.

[]{#P .anchor}**II. GENERAL INSTRUCTIONS**

ITEM 23: Potential Award Without Discussions, is applicable to this
solicitation.

ITEM 33: Small Business Subcontracting Plan is applicable to this
solicitation and the following information is provided to supplement
this item to assist in proposal preparation:

-   23% for Small Business

-   5% for Small Disadvantaged Business

-   3% for Women-Owned Small Business

-   5% for HUBZone Small Business

-   3% for Veteran-Owned Small Business

-   3% Service-Disabled Veteran-Owned Small Business.

ITEM 35: Extent of Small Disadvantaged Business Participation is
applicable to this solicitation.

ITEM 36: Salary Rate Limitation in Fiscal Year 2005, is applicable to
this solicitation.

ITEM 39: Past Performance Information is applicable to this solicitation
and the following information is provided to supplement this item to
assist in proposal preparation:

Past Performance information shall be submitted as part of the
[Business]{.underline} proposal.

> A list of the last three (3) contracts completed during the past three
> years and the last three (3) contracts awarded currently in process
> that are similar in nature to the solicitation workscope.

ITEM 48: Prohibition on Contractor Involvement with Terrorist
Activities, is applicable to this solicitation.

ITEM 49: Solicitation Provisions Incorporated by Reference: The
following provisions are applicable to this solicitation.

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

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

Preaward On-Site Equal Opportunity Compliance Evaluation, (Over
\$10,000,000), FAR Clause 52.222-24, (February 1999).

### 

### III. TECHNICAL PROPOSAL INSTRUCTIONS

**ITEM 51: Project Objectives, NIH-1688-1,** is applicable to this
solicitation.

**ITEM 54: Information Technology Systems Security**, is applicable to
this solicitation.

###  

### IV. BUSINESS PROPOSAL INSTRUCTIONS

ITEM 56: Proposal Cover Sheet, is applicable to this solicitation.

ITEM 57: Information Other than Cost or Pricing Data, is applicable to
this solicitation.

\[X\] This information may be submitted in the offeror\'s own format.

\[ \] This information shall be submitted in the following format.

ITEM 60: Requirements for Cost or Pricing Data or Information Other than
Cost and Pricing Data FAR Clause 52.215-20, is applicable to this
solicitation.

ITEM 65: Incremental Funding, is applicable to this solicitation.

ITEM 67: Certification of Visa's for Non-U.S. Citizens, is applicable to
this solicitation.

## SECTION M - EVALUATION FACTORS FOR AWARD

**TECHNICAL EVALUATION CRITERIA**

1.  **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/price, past performance and Small
> Disadvantaged Business (SDB) participation. Although technical factors
> are of paramount consideration in the award of the contract, past
> performance, SDB participation and cost/price are also important to
> the overall contract award decision. All evaluation factors other than
> cost/price, when combined, are significantly more important than cost
> or price. The trade-off process described in FAR 15.101-1 may be
> employed. This process permits tradeoffs among cost/price and non-cost
> factors and allows the Government to consider award to other than the
> lowest priced or highest technically rated offeror. 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 offerors 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.  **MANDATORY TECHNICAL QUALIFICATION CRITERIA**

> The mandatory qualification criteria establishes conditions that
> **[must be met at the time of receipt of the original proposal
> submission]{.underline}** by the Contracting Officer. If an offeror
> fails to meet these mandatory qualification criteria at the time of
> their original proposal submission, their proposal will not be sent
> forward for review and; therefore, will not be considered for award.
>
> Listed below are four mandatory qualification criteria. **\[[The
> offeror must include all information that documents and/or supports
> the Qualification Criteria in one clearly marked section of their
> proposal.]{.underline}\]**
>
> **[Mandatory Criterion #1]{.underline}**: Offeror(s)
> [must]{.underline} meet all applicable U.S. Food and Drug
> Administration current cGMP requirements, as specified in Title 21,
> Code of Federal Regulations, Parts 210 and 211. If a subcontractor(s)
> is proposed, it (they) must also meet the cited requirements.
> \[Provide Copies\]
>
> **[Mandatory Criterion #2]{.underline}**: Offeror(s)
> [must]{.underline} possess current licenses to distribute drugs and
> other agents, including controlled substances and ethanol-containing
> products, in its jurisdiction. \[Provide Copies\]
>
> **[Mandatory Criterion #3]{.underline}**: Offeror(s) proposed
> Principal Investigator and staff pharmacists [must]{.underline} be
> licensed to practice pharmacy in the offeror's jurisdiction. \[Provide
> Copies of licenses\]
>
> **[Mandatory Criterion #4]{.underline}**: Offeror(s)
> [must]{.underline} possess a current U.S. Environmental Protection
> Agency toxic waste generator permit and the necessary local and state
> permits for transportation of toxic wastes. \[Provide Copies of
> permits\]

**OFFEROR(S) AND REVIEWERS ARE ADVISED TO REFER TO [APPENDIX
A](#iv.-business-proposal-instructions) [-- Additional Technical
Proposal Instructions and Format for Technical Proposal Table of
Contents]{.underline} OF THIS SOLICITATION PACKAGE FOR GUIDANCE AND
INFORMATON RELATED TO THE PREPARATION AND EVALUATION OF PROPOSALS.**

3.  **TECHNICAL EVALUATION FACTORS** **WEIGHT**

    A.  **Technical Approach** **50 points**

> Adequacy and appropriateness of the offeror's understanding of the
> requirements as evidenced by the proposed technical approach to
> perform the following functions:

1.  **Pharmaceutical Services (20 points)**

    a.  Evaluating protocols; estimating study product needs and usage;
        processing orders from authorized investigators; and obtaining
        product documentation from manufacturers.

    b.  Supporting the pharmacy monitoring responsibilities of PAB,
        including review of clinical research site pharmacy site visits
        reports generated by the CSMGs and supporting pharmacy guidance
        activities of PAB.

2.  **Study Product Management (20 points)**

    a.  Receiving study products from manufacturers; performing QA
        activities; storing products under appropriate conditions;
        packaging and labeling; conducting physical inventories;
        tracking expiration or repass dates; and performing proper final
        disposition of study products

    b.  Shipping to authorized investigators; generating all necessary
        shipping documentation; and ensuring the integrity of the
        products to the final destination

    c.  Maintaining and updating CPIMS to support the activities of the
        CRPMC; providing for the security of all data and programs; and
        ensuring safe and orderly transition from the current contractor
        and to a potential successor contractor.

3.  **Communication and Interaction (10 points)\
    **

> Adequacy and suitability of the communication and interaction plan
> that demonstrates how the offeror will ensure its ability to address
> the needs of PAB, including interacting with senior government
> officials, approaches to resolving deficiencies, communication with
> ICRPMC, interacting with study product manufacturers, interacting with
> clinical research sites, interacting with other government
> contractors, interacting with embassies and customs officials, weekly
> protocol review meetings with PAB pharmacists, at least bi-weekly
> clinical research site pharmacy monitoring review meetings, and
> face-to-face meetings within 24 hours to resolve emergent and or
> urgent issues.

B.  **Personnel and Staffing** **30 points**

    1.  **Principal Investigator (PI) (15 points)**

> Adequacy of the documented training, experience, expertise and
> availability of the proposed PI with professional, technical and
> administrative competence and knowledge of applicable regulations to
> manage the CRPMC or a project of comparable size and complexity. The
> proposed PI must be a pharmacist; have adequate management experience
> in a hospital pharmacy of adequate duration; have adequate clinical
> research experience; possess demonstrated knowledge of pharmacy
> practice in order to identify
>
> issues, prioritize projects, identify qualified personnel, interact
> with research staff at sites, industry and the NIH; and provide
> technical assistance and oversight in the safe management of clinical
> study products.

2.  **Other Professional and Support Staff (15 points)**

> Adequacy of the documented training, experience, expertise and
> availability of other professional and support staff necessary to
> carry out the requirements of this contract. This includes: registered
> pharmacist(s), pharmacy technicians, other support and technical staff
> and computer support staff. Also to be evaluated will be the adequacy
> of the demonstrated experience in clinical site pharmacy monitoring,
> auditing and QA activities; demonstrated experience in training and
> education in clinical research pharmacy practice and the proposed
> strategy for providing backup support for the proposed project team.

C.  **Facilities, Equipment and Organizational Resources 20 Points**

> Suitability of the documented availability of adequate sanitary and
> environmentally-controlled facilities, equipment and organizational
> resources necessary for the safe, secure operation and maintenance of
> the CRPMC and ICRPMC; facilities to receive, store, ship and maintain
> the integrity of study products:

1.  detailed floor plan of the proposed facility showing the location of
    equipment, clean room(s), offices, shipping docks, freezers,
    refrigerators, quarantine areas, storage areas, packaging areas,
    labeling areas, study product processing, study product returns, and
    archival space

2.  information regarding ownership or lease of the facility
    demonstrating facility availability at the initiation of, and for
    the duration of the contract

3.  detailed description of equipment proposed for the project and its
    availability

4.  logistics plan for receiving, storing, packaging, labeling, and
    shipping study products domestically and internationally

5.  plan for compliance with all safety guidelines and regulations
    including training and monitoring of personnel for exposure to
    hazardous agents

6.  adequacy of all physical and electronic security systems for the
    facility and to prevent access to the CRPMC databases and computer
    related systems

7.  staffing plan delineating lines of authority, reporting
    responsibilities

8.  organizational experience in awarding and managing subcontracts

9.  staffing plan for a ICRPMC delineating lines of authority, reporting
    responsibilities, communication, fiscal oversight and management

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D.  **Case Study Exercises 20 points**

> Phase III Vaccine Case Study (10 points)
>
> Phase IV Therapeutics Case Study (10 points)
>
> Adequacy, thoroughness, and feasibility of the proposed approach to
> supporting the planning and conduct of hypothetical Phase III and
> Phase IV studies as provided in Appendix E. This includes plans and
> timetables for in-house activities and/or subcontractor acquisition,
> management and oversight efforts; and evidence of offeror's
> understanding of anticipated obstacles and challenges/barriers, and
> proposed solutions.
>
> TOTAL: **120 points**

4.  **PAST PERFORMANCE 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 the 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 all available and 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.

5.  **EXTENT OF SMALL DISADVANTAGED BUSINESS 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

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a.  Realism of the proposal

b.  Extent of participation of SDB concerns in terms of the value of the
    total acquisition.

[]{#T .anchor}**[APPENDIX A]{.underline} - ADDITIONAL TECHNICAL PROPOSAL
INSTRUCTIONS**

**FORMAT FOR TECHNICAL PROPOSAL -- [TABLE OF CONTENTS]{.underline}**

+-----------------------------------------------------------------------+
| **[THE BELOW TEMPLATE MUST BE USED AS THE [TABLE OF                   |
| CONTENTS]{.underline} FOR YOUR TECHNICAL PROPOSAL AND ALL INFORMATION |
| IN YOUR TECHNICAL PROPOSAL MUST BE PRESENTED IN THE ORDER SPECIFIED   |
| BELOW.]{.mark}**                                                      |
|                                                                       |
| []{.mark}                                                             |
|                                                                       |
| **[YOU ARE REMINDED THAT THE TOTAL PAGE LIMITATION FOR THE ENTIRE     |
| TECHNICAL PROPOSAL PACKAGE IS 150 PAGES (including a 20 page limit    |
| for Case Studies). PLEASE REFER TO THE FOLLOWING LINK FOR SPECIFIC    |
| PROPOSAL PREPARATION INSTRUCTIONS WITH REGARD TO PAGE                 |
| LIMITATIONS:]{.mark}**                                                |
|                                                                       |
| [**[http://www.niaid.nih.gov/contract/eproposal.htm#electronic]{      |
| .mark}**](http://www.niaid.nih.gov/contract/eproposal.htm#electronic) |
|                                                                       |
| []{.mark}                                                             |
|                                                                       |
| **[THESE ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS REFLECT THE       |
| REQUIREMENTS OF THE RFP AND ARE MEANT TO PROVIDE A CLEAR              |
| UNDERSTANDING OF THE INTENT OF THIS SOLICITATION.]{.mark}**           |
|                                                                       |
| []{.mark}                                                             |
|                                                                       |
| **[YOU ARE ADVISED TO GIVE CAREFUL CONSIDERATION TO THE STATEMENT OF  |
| WORK, ALL REFERENCE MATERIAL PROVIDED AS APPENDICES AND ATTACHMENTS,  |
| AND THE TECHNICAL EVALUATION CRITERIA IN THE DEVELOPMENT OF YOUR      |
| PROPOSAL.]{.mark}**                                                   |
+-----------------------------------------------------------------------+

**[TECHNICAL PROPOSAL -- TABLE OF CONTENTS]{.underline}**

**SECTION 1. MANDATORY QUALIFICATION CRITERIA**

SECTION M of this solicitation includes Mandatory Qualification
Criteria. **[The Mandatory Qualification Criteria must be met at the
time of the original proposal submission]{.underline}**. Information to
support compliance must be provided for the prime contractor and any
proposed subcontractor. All offerors must provide copies of all required
licenses, certifications, permits and all other requested supporting
documentation. If you fail to meet these criteria at the time of
original proposal submission, your proposal will not be submitted for
review and; therefore, will not be considered for award. Include in this
SECTION 1 of your Technical Proposal, copies of all materials necessary
to demonstrate that you have met the Mandatory Technical Qualification
Criteria. Properly label each item as to whether it applies to Mandatory
Criterion #1, #2, #3 or #4.

**SECTION 2. TECHNICAL APPROACH**

> **1. Initial Transition**
>
> Discuss your plans and procedures for executing an effective and
> efficient transition from the incumbent contractor in accordance with
> the requirements of paragraph 1., Statement of Work. \[NOTE: Include
> related cost as a separate cost element in your Business proposal.\]
>
> [NOTE]{.underline}: The current contractor will provide to the new
> contractor the existing Oracle data base management system of the
> CRPMC containing information on inventory, and necessary documentation
> of the activities of the CRPMC. A major component of the system is the
> module to track product requests from individual investigators. Other
> modules support production of standard reports, such as receiving and
> shipping. More specialized reports including inventory by product and
> by study protocol, list of clinical research sites and pharmacists of
> record that must also be made available. The CRPMC computer files will
> be transferred. Computers will not be transferred.
>
> **2. Pharmaceutical Services**
>
> Discuss procedures and demonstrate experience in the provision of
> pharmaceutical services for a wide variety of clinical trials
> conducted in the United States and internationally, including
> resource-limited countries in South America, the Caribbean, Africa,
> and Asia. Your proposal should discuss your plan and approach for:

a.  The plan and approach for establishing, staffing and managing the
    International CRPMCs proposed, including a discussion of the
    challenges, obstacles and difficulties involved to carryout the
    functions of this contract in international and especially
    resource-limited settings, and proposed approaches to dealing with
    country-specific requirements, limitations, cultural issues, etc.

b.  Reviewing and evaluating clinical trial protocol documents with
    regards to pharmaceutical needs and practice, and generating
    protocol-specific documents providing product ordering information.

c.  Proposed software to be used to project the quantities of clinical
    trials materials required.

d.  Communicating with pharmaceutical manufacturers for various reasons
    such as arranging shipments, obtaining documents, providing usage
    rates, requesting stability information, etc.

e.  Reviewing and documenting findings contained in pharmacy site visit
    monitoring reports.

f.  Guidance in clinical research pharmacy practice.

g.  Performing cGMP audits of manufacturing facilities.

h.  Providing assistance to clinical research site pharmacists for
    establishing research pharmacies, SOPs, and QA programs.

i.  Providing technical guidance to clinical research site pharmacists
    regarding the selection, acquisition, installation, operation and
    maintenance of equipment required for the conduct of clinical
    trials.

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3.  **Receipt and Storage of Study Products**

> Discuss your procedures and demonstrate your experience in performing
> the following:

a.  Arranging study product shipments with product manufacturers.

b.  Receipt, storage, and quarantine of study products at all
    temperatures as defined by USP.

c.  Continuous monitoring and documentation of storage temperatures and
    conditions.

d.  Receipt and processing of shipments through Customs.

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4.  **Labeling, Packaging and Repackaging of Study Products**

> Discuss your procedures and demonstrate your experience in performing
> the following:

a.  Repackaging study products in a clean room into a variety of
    packaging types, including patient specific packaging and kits in
    accordance with randomization schemes provided.

b.  Generating labels and affixing primary or auxiliary labels on 70,000
    units per year.

c.  Performing analytical work for identity testing.

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5.  **Shipping Preparation Procedures and Equipment**.

> Discuss your procedures and demonstrate your experience in performing
> the following:

a.  Validation testing for cold chain shipping containers.

b.  Preparing SOPs based on the results of validation testing.

c.  Preparing small shipments.

d.  Possessing and using equipment to prepare large shipments.

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6.  **Shipping and Distribution of Study Products**

> Discuss your procedures and demonstrate your experience in performing
> the following:
>
> a\) Evaluating study products orders and filling orders correctly.
>
> b\) Making up to 1,000 shipments per month under conditions compatible
> with study product storage requirements, domestically and
> internationally.
>
> c\) Using appropriate types and quantities of packaging components for
> the safe, intact arrival of study products.
>
> d\) Monitoring study product shipments with reusable electronic
> monitoring devices.
>
> e\) Selection of freight forwarders and couriers to meet the needs of
> the study products based on destination, cost, and performance
> history.
>
> f\) Reconciliation of accountability records at the end of selected
> studies.

7.  **Shipping Documents and Regulations**

> Discuss your procedures and demonstrate your experience in performing
> the following:

a.  Generating all required shipping documents.

b.  Determining required shipping regulations for international
    locations.

c.  Obtaining required import and export documents.

d.  Maintaining current licenses and permits for storing, handling,
    transporting, distribution of drugs, biologics, controlled
    substances, and study products containing ethanol.

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8.  **Inventory** **Management**

> Discuss your procedures and demonstrate your experience in performing
> the following:

a.  Monitoring inventory to determine usage rates, expiration dates and
    performing physical inventories.

b.  Monitoring expiration and repass dates.

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9.  **cCMP, Sanitation, and Environmental Control\
    **

> Discuss your procedures and demonstrate your experience in performing
> the following:

a.  Maintaining a facility compliant with the Federal Insecticide,
    Fungicide and Rodenticide Act (7 U.S.C. 135) and with Title 21, Code
    of Federal Regulations, Part 210 and 211.

b.  Providing humidity controlled and monitored conditions.

c.  Protecting study products sensitive to carbon dioxide or light.

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10. **Security and Safety of Study Products**

> Discuss your procedures and demonstrate your experience in performing
> the following:

a.  Procedures for securing study products, protecting them from theft,
    heat, light, water, fire; and monitoring and documenting the
    appropriate temperature conditions.

b.  Providing a continuous supply of power through the use of a
    generator or other systems.

c.  Providing cold storage in the event of a freezer or refrigerator
    failure for highly labile products.

d.  Developing SOPs for emergency situations.

e.  Handling controlled substances in compliance with U.S. Drug
    Enforcement Agency requirements.

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11. **Internal Training of CRPMC and ICRPMC Staff\
    **

> Discuss your procedures and demonstrate your experience in performing
> the following:

a.  Training of all internal staff for: facility security, fire drills,
    fire suppression, handling dry ice, personal protection, and
    chemical spill clean-up.

b.  Training of shipping technicians and pharmacists for following SOPs
    for packing validated shipping containers.

c.  Training of internal staff in the use of computer systems and
    software.

d.  Training all pertinent staff to follow applicable SOPs and
    documenting the review.

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12. **Final Disposition of Study Products**

> Discuss your procedures and demonstrate your experience in performing
> the following:

a.  Identifying study products that need to be removed from stock at the
    CRPMC and at the domestic and international clinical research sites.

b.  Notifying clinical site pharmacists regarding final disposition of
    study products.

c.  Providing quarantine space at the appropriate storage temperature.

d.  Processing and documenting returned study products from clinical
    research site pharmacists.

e.  Disposing of returned products in accordance with all applicable
    local, state and Federal laws and regulations for both domestic and
    international clinical research sites.

f.  Handling of returned study products in a manner that meets all
    public and occupational health, safety and environmental protection
    regulations for both domestic and international clinical research
    sites.

g.  Documenting the disposition of study products.

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13. **Data Management**

> Discuss your plans and procedures and demonstrate your experience in
> performing the following:

a.  Providing data management systems compatible with the ORACLE based
    system of the current CRPMC (CPIMS)

b.  Providing validation processes to ensure the integrity of the data.

c.  Developing new software programs as required.

d.  Interfacing with the DAIDS-Enterprise System (see Appendix C for
    information on the DAIDS-Enterprise System).

e.  Maintaining files and reports as specified in the Statement of Work.

f.  Protecting against intrusion into the databases by computer viruses,
    spam, ad-ware, worms and other such intrusions.

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14. **Administrative Support**

> Discuss your plans and procedures and demonstrate your experience in
> performing the following:

a.  Providing designated and qualified personnel to maintain records of
    all CRPMC SOPs.

b.  Creating and standardizing templates for documents, memorandums,
    notifications, and letters.

c.  Maintaining copies of all communications.

d.  Archiving shipping reports and documents related to the distribution
    of study products.

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15. **Purchasing of Study Products**

> Discuss your plans and procedures for performing the following:

a.  Purchasing study products at the request of the NIAID Project
    Officer.

b.  Interacting and coordinating with DAIDS-funded Clinical Trials
    Network Operations Offices and Statistical and Data Management
    Centers.

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16. **Management and Oversight of ICRPMCs**

> Discuss your plans and procedures for having one or more International
> CRPMCs. Discuss your plans and experience in performing the oversight
> and management of all activities of the international CRPMC by the
> Principal Investigator .

17. **Final Transition (Contract Completion)**

> Discuss your plans for transition at the completion of the contract if
> it should be awarded to you.

**SECTION 3. COMMUNICATION AND INTERACTION**

Discuss your communication and interaction plan including:

1.  Experience and capability to interact with senior government
    officials,

2.  Experience and capability in preparing status and decision documents
    for senior government officials.

3.  Experience and approaches to resolve deficiencies.

4.  Experience and capability to interact with clinical research sites.

5.  Experience and capability to interact with study product
    manufactures.

6.  Experience and capability to interact with other government
    contractors.

7.  Plans and procedures for interacting with ICRPMC.

8.  Experience and capability to interact with embassies and customs
    officials.

9.  Plans for availability for weekly protocol review meetings with PAB
    pharmacists, at least bi-weekly site pharmacy monitoring review
    meetings and the need to be able to meet face-to-face within 24
    hours notice to resolve emergent or urgent issues.

**SECTION 4. PERSONNEL AND STAFFING**

1.  **Principal Investigator and Pharmacists**

> Several registered pharmacists will be required for this proposed
> contract.
>
> Describe the experience and qualifications for the Principal
> Investigator and other pharmacists as well as the percentage of the
> total time each will be committed to the project. Identify other
> active or planned projects that proposed key personnel are currently
> committed to or planned to be committed to and the percent of effort
> committed. Identify the composition of the task or work group, its
> general qualifications and experience in the last four years with work
> efforts consistent with this SOW. As a minimum, this effort will
> require different staff and areas of expertise at different times over
> the course of the contract. Provide documentation to describe:

-   Principal Investigator and pharmacists (limit CVs to 2-3 pages for
    the Principal Investigator and 1 page for all additional
    pharmacists).

-   Qualifications and experience as supported by academic degree(s),
    expertise, and specialized training.

-   Availability of Key and high level personnel for the proposed
    project.

-   Managerial ability to achieve delivery and performance requirements
    as demonstrated by the proposed use of management and other
    personnel resources and to oversee and implement the day-to-day
    project successfully as demonstrated by providing a comprehensive
    written Management Plan and previous relevant experience.

2.  **Other Personnel (technical and administrative staff)**

> Discuss the related experience and the role of other personnel
> including facility managers, pharmacy technicians, shipping
> technicians, and recall technicians. Provision of curriculum vitae(s)
> for these proposed personnel is not required with the Technical
> Proposal but may be included with the Business Proposal.
>
> Provide documentation of [relevant]{.underline} training, education,
> expertise, experience, competence and availability of the proposed
> staff to perform their functions in the proposed effort.

3.  **Staffing Plan of CRPMC**

> Describe the adequacy of your staffing plan for the conduct of the
> contract including a strategy for providing back-up support, the
> appropriateness of the time commitment of all staff in consideration
> of the proposed schedule for achieving contract objectives, and
> monitoring quality control over all operations.

4.  **Staffing and Management of ICRPMC**

> Discuss your plans and experience in performing oversight and
> management of all activities of the ICRPMC including staffing plan,
> lines of authority, reporting responsibilities, and anticipated
> limitations, problems, and obstacles along with proposed approaches
> for resolutions.

**SECTION 5. FACILITIES, EQUIPMENT AND ORGANIZATIONAL RESOURCES**

> Provide information that addresses the following:

1.  Ability to provide 25,000 square feet of storage at controlled
    temperature, USP.

2.  Ability to provide 10,000 cubic feet of storage at 2 to 8°C.

3.  Ability to provide 2, 5000 cubic feet at -20°C.

4.  Ability to provide 50 cubic feet at -80°C.

5.  Ability to provide a suitable area in which to quarantine study
    product at the proper storage temperature.

6.  Ability to provide physical and electronic security for the
    facility, study products, and computer related systems.

7.  Ability to provide office space for all pharmacists.

8.  Ability to provide desk space for all technical and administrative
    staff.

> Document the availability of facilities, equipment and resources for
> this project.
>
> Provide the following information:

1.  A description of proposed location for the CRPMC.

2.  A detailed floor plan of the proposed facility and list equipment
    and resources that will be dedicated to the project. (A list of
    Government-furnished property that can be available for transfer to
    the winning offeror is provided in Appendix D.)

3.  Copies of lease agreements for any rental space. Discuss any plans
    to construct new space or the need to renovate existing space. If
    space is not currently available, discuss the plans to have the
    space available and ready for operation upon award of the contract.

4.  A plan for receiving, packaging, labeling, and shipping study
    products domestically and internationally.

5.  The company's organizational chart delineating lines of authority
    and reporting responsibilities.

6.  Organization's plan for awarding and managing subcontracts.

7.  A plan for compliance with safety guidelines and regulations.

**SECTION 6. CASE STUDY EXERCISES (See APPENDIX E)**

> Discuss the plan proposed to support the case studies including
> proposed staffing, management, oversight, application of SOPs and any
> obstacles or problems foreseen. The response to the case studies is
> limited to a total of 20 pages for both cases studies together. ***The
> case study response pages are included in the total 150 page limit.***

**SECTION 7. INFORMATION TECHNOLOGY SYSTEMS SECURITY**

Discuss the plan proposed to ensure the security of Information
Technology Systems **.**

[]{#U .anchor}**[APPENDIX B]{.underline} - ADDITIONAL BUSINESS PROPOSAL
INSTRUCTIONS**

**[UNIFORM COST ASSUMPTIONS]{.underline}**

**These are the uniform cost assumptions that the offeror should make to
prepare the business proposal.**

1.  Assume that 50 new studies will be initiated by DAIDS per year.

2.  Assume that pharmacists' duties will require 6 to 7 full time
    equivalents (FTEs).

3.  Assume that technician, administrative, and facility managerial
    duties will require 7 to 8 FTEs.

4.  Include in your business proposal an amount of \$40,000 for
    consultants to audit product manufacturing facilities, to develop
    site pharmacy QA programs, and to provide technical guidance for the
    selection and installation of pharmacy equipment. Escalate this cost
    annually based on the current Consumer Pricing Index (CPI). Estimate
    a total of four trips per year for 1-2 people.

5.  Assume 6 to 10 meetings per year of DAIDS-funded Clinical Trials
    Networks within a 50 mile radius of Washington, DC. Assume all CRPMC
    pharmacist will attend the clinical site pharmacist meeting. The
    CRPMC PI and 1-2 other pharmacist will attend the entire meeting.
    Assume meetings will be 3-4 days in length.

6.  Assume four additional half-day meetings per year for 1-2 people
    within a 50 mile radius of Washington, DC.

7.  Include in your business proposal an amount of \$136,000 per year
    for domestic and foreign travel for the purpose of conducting
    pharmacy site visits. Escalate this cost annually based on the
    current (CPI).

8.  Assume that 40 different study products consisting of 10,000 units
    per year will be repackaged.

9.  Assume that 2-3 studies per year, consisting of 2-3 study products
    each, will be provided in patient specific, unit of use, packaging
    such as blister packaging.

10. Assume that 400 different study products consisting of 70,000 units
    per year will be required to be labeled.

11. Assume that up to 6 different shipment packing configurations will
    be validated per year.

12. Assume that approximately 12,000 shipments will be made each year.

    a.  Assume that 25% of study product shipments will be to
        international sites and must be delivered within three to five
        days.

    b.  Assume that 75% of study products shipments will be to domestic
        sites and must be delivered within 24 hours.

13. Offerors will be able to utilize U.S. General Services
    Administration domestic shipping prices for costing purposes.

14. Include in your business proposal an amount of \$257,750 per year
    for packaging and shipping. Escalate this cost annually based on the
    current (CPI)

15. Include in your business proposal an amount of \$75,000 per year for
    the purchase of study products that cannot be obtained through
    donation. Escalate this cost annually based on the current (CPI)

16. The CRPMC is expected to have an on the ground/in-country presence
    and have distribution facilities in various regions of the globe.
    This international presence can be accomplished with branch offices
    in international locations or through the use of subcontractor(s).
    Locations that require on-the-ground presence are the continents of
    Africa, Asia, South America and the Caribbean.

17. Offerors must include with their Business Proposal, as a separate
    cost element, costs associated with the initial transition from the
    incumbent contractor to a successor contractor.

[]{#V .anchor}**APPENDIX C**

**Overview of DAIDS-Sponsored HIV/AIDS Clinical Trials Networks and
Selected**

**DAIDS Support Contracts**

1.  The current DAIDs-sponsored HIV/AIDS Clinical Trials Networks and
    the accomplishments of each are described below.

-   **The Acute Infection/Early Disease Research Program** (AIEDRP),
    [[http://www.aiedrp.org]{.underline}](http://www.aiedrp.org/),
    established in 1997, performs innovative, integrated, pathogenesis
    and clinical research on acute and early HIV infection. The program
    consists of 5 main units and conducts independent and collaborative
    virologic and immunologic evaluations into the pathogenesis of acute
    and early HIV infection and studies the potential effectiveness of
    therapeutic interventions.

> The AIEDRP has focused on the development of close links between
> clinical and basic research, resulting in studies showing the
> relationship between pathogenesis and treatment, including
> implications for vaccine research. The AIEDRP has conducted key
> studies of the pathogenesis of HIV infection, especially CD4+ cell
> dysfunction and HIV viral resistance, and this group has established
> the AIEDRP Cohort in order to obtain long-term clinical and laboratory
> data on people with acute HIV-1 infection.

-   **The Adult AIDS Clinical Trials Group** (AACTG),
    [[http://aactg.s-3.com]{.underline}](http://aactg.s-3.com/),
    established in 1987 as the AIDS Clinical Trials Group, investigates
    the pathogenesis of HIV and its complications, therapeutic
    interventions for the treatment of HIV disease, the prevention and
    treatment of HIV/AIDS-related co-infections and disorders, and
    complications of therapy.

> Studies conducted by the AACTG have produced dramatic improvements in
> the clinical care, quality of life, and survival of persons with
> HIV/AIDS. The AACTG conceived, developed, conducted, and published the
> majority of the ground-breaking randomized clinical trials that are
> the basis of the current national and international antiretroviral
> therapy (ART) and opportunistic infection (OI) treatment and
> prevention guidelines for the management of HIV-1-infected adults. The
> AACTG has completed over 360 clinical trials and generated more than
> 1000 publications with over 300 of these appearing in first-line,
> peer-reviewed journals.
>
> The AACTG established and supports the largest network of expert
> clinical and translational investigators and therapeutic clinical
> trials units in the world, now including sites in resource-limited
> countries. These investigators and units serve as the major resource
> for HIV/AIDS research, treatment, care, and training/education in
> their communities. The AACTG has been responsible for the education
> and training of a large proportion of the current and future HIV/AIDS
> translational laboratory and clinical investigators in the U.S.

-   **Evaluation of Subcutaneous Proleukin in a Randomized International
    Trial** (ESPRIT),
    [[http://www.espritstudy.org]{.underline}](http://www.espritstudy.org/)
    is a randomized, international study of interleukin-2 (IL-2) in
    people with HIV infection and a CD4+ cell count of at least 300/mm3.
    The goal of the study is to evaluate and compare the effectiveness
    of IL-2 plus ART versus ART alone on the number and severity of
    AIDS-related illnesses and deaths. This unique immune-based therapy
    has the potential to circumvent the limitation of resistance
    emerging to conventional therapy.

> ESPRIT is being conducted in 25 countries. An international management
> structure coordinates this large study of over 4000 participants at
> more than 250 diverse settings. Many of these sites overcame unique
> problems in pharmacy, laboratory, ethics, standards of care, data and
> safety management and communication.

-   **The HIV Prevention Trials Network** (HPTN),
    [[http://www.hptn.org/index.htm]{.underline}](http://www.hptn.org/index.htm),
    is a worldwide collaborative Clinical Trials Network that develops
    and tests the safety and efficacy of primarily non-vaccine
    interventions designed to prevent the transmission of HIV.
    Established in 1999, the HPTN carries out its mission through a
    strong Network of expert scientists and investigators from more than
    two dozen international sites.

> Two significant prevention studies were initiated by the HIVNET and
> concluded by the HPTN. HIVNET 012 is a landmark study that proved the
> safety and efficacy of a simple drug regimen for preventing
> mother-to-child transmission of HIV-1. This successful regimen has
> already been implemented in many locations worldwide as the basis of
> effective public health efforts to reduce HIV infections in newborns.
> HIVNET 015, A Randomized Clinical
>
> Trial of the Efficacy of a Behavioral Intervention to Prevent
> Acquisition of HIV among Men who have Sex with Men (MSM), demonstrated
> the feasibility of delivering intensive, targeted interventions to
> reduce HIV risk behaviors and was the first randomized, controlled
> clinical trial to evaluate the impact of a behavioral intervention on
> HIV acquisition.

-   **HIV Vaccine Trials Network** (HVTN),
    [[http://www.scharp.org/hvtn]{.underline}](http://www.scharp.org/hvtn/),
    is an international collaboration formed in 1999 to conduct vaccine
    clinical trials in humans worldwide. The HVTN provides data on the
    safety, immunogenicity and efficacy of candidate vaccines designed
    to reduce HIV acquisition, transmission and progression. The HVTN
    has demonstrated notable leadership in the advancement of novel
    candidate vaccines into human trials and the validation of key
    immunological assays for the comparative assessment of those
    candidates.

> The HVTN (and formerly HIVNET) has successfully completed over 50
> trials in the U.S. and abroad, ascertaining the safety and
> immunogenicity of multiple vaccine designs and products. This body of
> work has narrowed the number of approaches that effectively induce
> antibodies and identified vaccines that induce cell-mediated immunity.

-   **The Pediatric AIDS Clinical Trials Group** (PACTG),
    [[http://pactg.s-3.com]{.underline}](http://pactg.s-3.com/),
    established in 1987 as part of the AIDS Clinical Trials Group,
    addresses critical questions that include: determining the best ways
    of interrupting mother-to-child transmission (MTCT) of HIV; treating
    HIV infection and its complications in pregnant women, infants,
    children and youth; and assessing long-term anti-HIV drug safety and
    HIV disease progression and pathogenesis in this unique population.
    The PACTG is a joint effort of NIAID and National Institute of Child
    Health and Human Development.

> The PACTG defined treatments that have reduced MTCT of HIV in the U.S.
> from 25% to 1.5% and has developed many of the MTCT regimens used in
> resource-limited nations. The PACTG also defined the unique treatment
> of HIV-infected pregnant women. Virtually all of the data on the
> safety of ART regimens during pregnancy have been generated by the
> PACTG and have contributed significantly to the PHS Perinatal
> Treatment Guidelines.
>
> In addition, PACTG investigators have been leaders in the development
> of guidelines for the care and treatment of HIV-infected children in
> the U.S. and the PACTG provided pivotal data for approximately
> two-thirds of the anti-HIV drugs approved by the Food and Drug
> Administration (FDA) for use in children. PACTG studies continue to
> evaluate additional anti-HIV drugs for pediatric use. PACTG
> investigators have trained a generation of laboratory and clinical
> pediatric HIV investigators. The PACTG also has contributed
> extensively to the understanding of the pathogenesis of HIV in the
> pediatric population, including the unique nature of neonatal HIV
> infection, co-receptor usage in children and pediatric-specific HIV
> disease markers that are now used in assessing the effectiveness of
> ART in children.

-   **The Terry Beirn Community Programs for Clinical Research on AIDS**
    (CPCRA),
    [[http://www.cpcra.org]{.underline}](http://www.cpcra.org/), was
    established in 1990 to perform clinical research in primary care
    settings that answers questions important in the daily lives of
    people living with HIV/AIDS, particularly populations generally
    under-represented in research studies and their health care
    providers.

> The CPCRA involves people living with HIV/AIDS and their primary care
> providers in all aspects of clinical trial design and implementation
> and is a leader in long-term strategy trials that evaluate combination
> antiretroviral therapies, structured treatment interruption and other
> approaches easily exportable to primary care clinical settings. The
> CPCRA also has conducted pivotal research in the management of
> HIV-associated opportunistic infections and has helped determine
> optimal prophylaxis regimens for Pneumocystis carinii and
> toxoplasmosis, Mycobacterium avium complex treatment, withdrawal of M.
> avium complex prophylaxis, shorter tuberculosis prophylaxis, and
> evaluated regimens for the prevention of cytomegalovirus disease and
> oral and vaginal candidiasis.
>
> The CPCRA is currently undertaking 'Strategies for Management of
> Anti-Retroviral Therapy\' (SMART), a large 6000 participant strategy
> trial to study whether continuous treatment with antiretrovirals to
> maintain viral suppression is better than intermittent treatment to
> maintain CD4 cell counts above 250 cells/mL. The trial is being
> conducted internationally in conjunction with the Copenhagen HIV
> Programme, the Medical Research Council (UK) and the National Centre
> in HIV Epidemiology and Clinical Research (Australia).
>
> The current DAIDS-supported HIV/AIDS Clinical Trial Networks are being
> restructured. Three to six HIV/AIDS Clinical Trials Networks will be
> established to carry out the NIAID research agenda in the following
> areas: (1) Vaccine Research and Development; (2) Translational
> Research/Drug Development; (3) Optimization of Clinical Management,
> Including Co-Morbidities; (4) Microbicides; (5) Prevention of
> Mother-to-Child Transmission (MTCT) of HIV; and (6) Prevention of HIV
> Infection. Each Network Leadership will consist of three components:
> (1) a Coordinating and Operations Center (CORE) to provide scientific
> and administrative leadership, central operations, and communications;
> (2) a Statistical and Data Management Center (SDMC) to provide
> biostatistical leadership and central data management; and (3) a
> Network Laboratory Structure to provide the laboratory services
> necessary to conduct the clinical research. Clinical Trial Units will
> be solicited in a subsequent, linked RFA titled 'Units for HIV/AIDS
> Clinical Trials Networks \'. The resulting combination of a Network
> Leadership and affiliated Clinical Trial Units will constitute an
> HIV/AIDS Clinical Trials Network. More information regarding the
> Request for Applications (RFA), "[Leadership for HIV/AIDS Clinical
> Trials Networks,"]{.underline} can be found at:
> [[http://www.niaid.nih.gov/daids/rfa/network06]{.underline}](http://www.niaid.nih.gov/daids/rfa/network06)
> . The RFA will be published in the NIH Guide to Grants and contracts:
> http://grants2.nih.gov/grants/guide/.

**2. DAIDS Contractor Overview**

> DAIDS has entered into contracts with a number of companies that
> provide a variety of support and services to the expansive portfolio
> of DAIDS-funded vaccine, prevention, and therapeutic clinical trials.
> The scope of work involved in these contracts extends to over 900
> clinical research sites located in more than 40 countries. These
> contractors work closely with DAIDS-funded Clinical Trials Networks,
> non-Network clinical research sites, clinical investigators, Network
> Central Laboratories, Operations Offices, and Statistical and Data
> Management Centers. Several of the contractors with whom the
> successful offeror selected for this award is expected to interact in
> order to perform certain 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 require interaction.

**3. DAIDS-Enterprise System (DAIDS-ES) Information Technology
Contractor**

> Contract N01-AI-30060 is held by Capital Technology Information
> Services (CTIS), Inc., located in Rockville, MD. In June of 2002 the
> DAIDS-ES Team performed an analysis and initiated a reengineering of
> DAIDS' business processes with the goal of overcoming information
> access barriers and to begin the architectural development of a DAIDS
> Enterprise System. The DAIDS-ES will ultimately integrate the modules
> involving key business areas that support the DAIDS agenda in HIV/AIDS
> vaccine, prevention and therapeutics research. The DAIDS-ES will also
> create a foundation for new applications and provide a common user
> experience for the Division with the benefit of lower infrastructure
> and development costs. As Clinical Trials Networks and contractors
> initiate work within the DAIDS system, each entity will be expected to
> interface with the DAIDS-ES IT Contractor.
>
> **Memorandum of Agreement (MOA)**
>
> A memorandum of agreement will be established between DAIDS and the
> owners/providers of applications/systems sharing data/information with
> the DAIDS-ES. The MOA will detail the rules of behavior and controls
> that must be maintained and will address issues including:
>
> • Security concerns
>
> • Rules for interconnecting applications/systems
>
> • Availability of data sharing services
>
> • Frequency of data exchange and data access
>
> • Data quality/integrity
>
> **Data Exchange Guidelines**
>
> DAIDS-ES will interact with other systems for document transport and
> routing, data transformation and data sharing.
>
> **Technology**
>
> External systems may utilize open protocols such as HTTP, FTP, and
> SMTP to transmit data to DAIDS-ES. DAIDS-ES will develop reusable
> components that will be made available to external systems, including
> but not limited to, shareable algorithms, procedures and graphical
> user interface (GUI) components.
>
> The successful Offeror will be required to interface, integrate or
> adapt its information systems(s) to interact with these and future
> components of the DAIDS-ES as necessary.
>
> To achieve compatibility, DAIDS and its collaborators (contractors,
> cooperative agreement holders, grantees, etc.) will implement
> applications or data exchange mechanisms using platform technology
> standards such as: Web Services, eXtensible Markup Language (XML), XML
> Schema Definitions (XSD), RDBMS, .NET Framework, UDDI, IIS, Internet
> Explorer, Service Oriented Architecture (SOA), Design Patterns,
> Frameworks and Templates as defined by the DAIDS-ES. Collaborators
> shall adhere to these guidelines and standards on a continual basis.
>
> This requirement will include the need to utilize DAIDS-ES specified
> software Application Programming Interfaces (APIs) or XML and XSD,
> where appropriate, in all relevant applications that affect specific
> types of transactions, GUIs and other software-based tasks that
> interact with or become part of the DAIDS-ES.
>
> Depending upon the architecture and implementation of the successful
> Offeror's data management system(s), the following activities may be
> required to be compatible with the DAIDS-ES:
>
> *Build Interface*:
>
> Using DAIDS-ES specified data standards, collaborators shall provide
> access to data in their local systems(s). Standards shall either be
> industry data exchanges standard such as those specified by NIH,
> CDISC, HL7 or adapted versions of these as defined by DAIDS.
>
> *System Adaptation*:
>
> Collaborators may need to adapt or modify their data management
> systems(s) to receive and store data from the DAIDS-ES. For example,
> DAIDS is establishing a standardized naming and numbering convention
> for its awardee institutions. DAIDS shall provide collaborators with a
> single set of institution or laboratory names and identifiers for all
> of its research participants. Collaborators' data systems(s) may have
> to be adapted or modified to accommodate the DAIDS standard(s).
>
> *System Integration*:
>
> Collaborators may be required to dynamically obtain data from the
> DAIDS-ES to perform specific job functions. This will require the
> integration of collaborators' system(s) with the DAIDS-ES via data
> linkages using the appropriate latency factor or through Web Services.
> For example, the DAIDS-ES will serve as the central repository for
> investigator and protocol status information. Collaborators whose work
> requires information from the DAIDS-ES must dynamically integrate it
> into their respective data systems(s).
>
> **Accuracy & Completeness**
>
> External systems providing data will be required to ensure the
> accuracy and completeness of data by following best practices such as:
>
> • Use of documented and standardized data collection mechanisms
>
> • Use of required fields that supports completeness of information
>
> • Use of edit checks, range checks and standardized coding
>
> **Appropriate Use**
>
> As DAIDS-ES data may contain confidential and/or sensitive
> information, recipients of data from DAIDS-ES will be required to
> implement "appropriate and judicious data practices." In the case of
> research data, NIH policy on data sharing will be followed. More
> information on NIH policy can be found at
> <http://grants1.nih.gov/grants/policy/data_sharing/>.
>
> The current components of the DAIDS-ES include:
>
> *DAIDS Training Calendar*
>
> The DAIDS Training Calendar is an integrated MS-Outlook application
> that tracks DAIDS training events. The DAIDS Training Calendar has
> been developed in response to the need for an easy-to-use system for
> tracking and sharing information about training activities, including
> content, schedule, participants, travel requirements, registration
> policies, costs, etc.
>
> *DAIDS Master Contact System*
>
> The DAIDS Master Contact System is a centralized system for all
> address and contact information for stakeholders engaged in clinical
> research, such as investigators, participating institutions,
> laboratories, agencies, pharmaceutical sponsors, manufacturers, etc.
> The system is anticipated to be operational in Q1 2005.
>
> *DAIDS Expedited Adverse Event Reporting System (DAERS)*
>
> The DAERS is a web-based application for expedited reporting of
> adverse events in DAIDS-sponsored clinical trials. DAERS is a 21 CFR
> Part 11 compliant system for use in therapeutic, vaccine and
> prevention trials. The system is anticipated to come on-line in Q3
> 2005.
>
> *DAIDS Protocol Management System*
>
> The DAIDS Protocol Management System supports end-to-end clinical
> trials processes, including: protocol development, registration,
> conduct, accrual, oversight, site monitoring, tracking and closeout.
> The system is CDISC and HL7 compliant with full auditing capabilities.
> The system is anticipated to be activated in Q4 2005.

**4. DAIDS Regulatory Compliance Center (RCC) Contractor**

> Contract N01-AI-30032 with Technical Resources International, Inc.,
> located in Bethesda, MD, provides regulatory support for all
> DAIDS-funded clinical trials. The RCC works closely with DAIDS and all
> DAIDS clinical research sites. The RCC will establish links with the
> Network Statistical and Data Management Centers. The RCC contractor
> performs the following:

-   prepares IND submissions

-   receives and processes reports of Serious Adverse Events

-   reviews protocols and informed consents for compliance with
    regulations

-   provides IND management support to DAIDS

-   works with DAIDS Medical Officers during the protocol generation
    process, and during safety monitoring of all DAIDS IND trials

-   distributes original and all subsequent IND submissions to the FDA,
    the participating pharmaceutical company, and parties within DAIDS

-   processes site/protocol registration and assures each site has
    appropriate protocol registration documents prior to protocol
    initiation.

-   provides protocol registration approval information to the CRPMC

**5. DAIDS Clinical Site Monitoring Contractors**

> DAIDS currently utilizes two contractors to evaluate good clinical
> research practice, regulatory compliance, accurate protocol
> implementation, international quality assurance, and test agent
> accountability during periodic on-site visits to all DAIDS-funded
> clinical research sites. These contractors (PPD Development Inc., in
> Wilmington, NC, N01-AI-05405, and Westat, Inc., located in Rockville,
> MD, N01-AI-15445) perform the following:

-   examine source documents to assess accuracy and completeness of
    trial data

-   identify problems with protocol implementation, adherence to Good
    Clinical Practice (GCP) and all applicable regulatory requirements

-   verify proper storage, dispensing and accountability of
    investigational study products

-   provide training on general protocol conduct, GCP, quality
    management, and DAIDS procedures

-   review internal quality assurance/quality control plans

-   interacts with the CRPMC to provide clarification of content of
    clinical site visit reports

**6.** **[DAIDS Clinical Research Products Management Center\
]{.underline}**

> Contract N01-AI-85352 with McKesson BioServices, Inc. provides
> contractor support to the DAIDS Clinical Trials Networks through
> managing the storage and shipment of clinical research products used
> for Network trials. The contractor is staffed by registered
> pharmacists and is located in Rockville, MD. Each Network and all
> Network grantees interface with this contract during the conduct of a
> protocol in order to receive product. Specific responsibilities of
> this contractor include:

-   Receipt and storage of study products

-   Security and safety

-   Inventory management

-   Packaging and labeling

-   Shipping and distribution

-   Processing and disposal of returns

-   Database of inventory and distribution

-   Coordination with international shippers

[]{#W .anchor}APPENDIX D

RFP‑NIH‑NIAID‑DAIDS‑06-05

LIST OF GOVERNMENT FURNISHED PROPERTY

1\. Equipment: The below listed equipment provided to the CRPMC is under
preventive maintenance contract and is in good working condition.

  ------ --------------------------------------------------- --------------
  Qty.   Equipment                                           Date Purchased

  1      Xerox Copier Model 5818                             Aug-98

  1      Hewlett-Packard Laser Printer Model Laserjet II     Feb-89

  3      United Electronic Controls 7-Day Recording          Dec-89
         Controller w/Thermocoupler Wire Model 16135/T650    

  1      Kirby Lester Tablet Counter Model KL100             Jul-93

  1      Harris (-80) C Low-Temperature Chest Freezer Model  Apr-92
         DLT-20L5-903                                        

  3      Gateway Vivitron 17\" Monitor Model CPO-GF-250T LP  Jan-98
         Mini tower                                          

  3      Gateway E-3110-266MHZ PC Model LP Mini tower        Jan-98

  2      Gateway File Server Model NS-7000                   Jan-98

  1      Hewlett-Packard Laserjet Printer 2100TN Model C4172 Jul-99

  1      Ancel Fire Suppression System Model Inergen         Nov-98

  1      Radionics Security System Model 07000/09000         Nov-98

  1      Lucent Phone System Model Partner                   Nov-98

  1      Dell 550 MHZ Pentium III PC & Monitor Model         Feb-00
         6271RBOC70CC9                                       

  1      Dell 1GHZ Pentium III PC & Monitor                  Aug-01

  1      Dell 800 MHZ Pentium III PC & Monitor               Dec-00

  3      Dell 733 MHZ Pentium III PC & Monitor               Oct-00

  1      Zebra Label Printer (Direct/Thermal Transfer Model  Jul-01
         Z6000                                               

  1      VWR Balance Sartorius Model BP3100                  Apr-01

  5      Dell Pentium IV & monitor Dimension 8300            May-03

  1      Hewlett-Packard Laserjet Printer 4300 Model         Sep-03
         Laserjet IV                                         

  1      Harris Upright freezer Model SLT-25V-85             May-04
  ------ --------------------------------------------------- --------------

2.  Investigational Study Products:

> Any and all study products on‑hand *(including* active and quarantine
> inventories).

3.  Packing Materials:

> Any and all packing materials on‑hand (including box flats, wet ice,
> foam assemblies, microfoam padding, electronic temperature monitoring
> devices, styrofoam \"peanuts,\" reinforced and clear tape, validated
> shipping containers, pallets, shipping labels, etc.).

4.  Computer Software:

> Any and all computer software on‑hand *(*including the Clinical
> Products Inventory Management System \[CPIMS\], software for
> downloading data from electronic temperature monitoring devices,
> software for downloading electronic adherence devices, labeling
> software etc.).

5.  Packaging Validation Procedures

> Standard operating procedures developed after validation testing of
> shipping containers.

6.  Source Books/Copies of Literature Available only by Subscriptions:

    a.  USP XXXII/NF XVII

    b.  Martindale\'s The Extra Pharmacopoeia

    c.  ASHP Handbook of Injectable Drugs

    d.  The Merck Index

    e.  Facts & Comparisons

    f.  Medical Economics Physician\'s Desk Reference

    g.  AHFS Drug Information

    h.  ImmunoFacts

7.  Paper Files:

> Accumulated paperwork (including drug receipt documentation,
> protocols, processed orders, vendor invoices, daily shipping reports,
> etc.) requiring ten (10) 4-drawer file cabinets, one (1) 2-drawer
> cabinets, and eight-two (82) boxes to accommodate.

[]{#X .anchor}**[APPENDIX E]{.underline}**

**[CLINICAL TRIAL CASE STUDIES]{.underline}**

The offeror must provide a detailed operating plan with a full technical
approach to support one Phase III vaccine trial and one Phase IV
treatment trial with the specifications listed below.

The plan must be written in the context of the overall capabilities,
personnel and fiscal resources of the CRPMC. Discuss how SOPs will be
applied and implemented to perform these tasks. Copies of SOPs do not
need to be submitted, a list of applicable SOPs may be submitted.
Request for copies of SOPs may be requested from offerors with proposals
in the competitive range. The plan must address the following:

-   Receipt and storage of study products

-   Inventory management

-   Shipping specifications, methods and documentation

-   Shipment allocations, initially and during the trial

-   Communication with the sites

-   Communication with DAIDS PAB

-   Communication and coordination with product manufacturers

-   Packaging and labeling issues

-   Randomization issues

-   Study closure requirements

-   Expiration date issues

-   Extension of trial duration due to low number of endpoints

-   Addition of new sites due to slow enrollment

-   Increase in trial sample size

-   Control and oversight mechanisms

-   Storage problems at the clinical sites

-   Need to replace product

-   Staff requirements

-   IT requirements

Assume that the offeror will provide either the services necessary to
support the initiation, conduct and termination of these trials or may
subcontract any activities that are not indicated in the Statement of
Work as having to be performed by the CRPMC.

Discuss the proposed utilization of subcontractors for this plan and the
subcontract award process. Describe any additional tasks that would
typically need to be added during the conduct of the study and note
whether they would be performed by the CRPMC or a subcontractor. Provide
a cost estimate for performing the activities of the CRPMC in support of
each study.

Any assumptions made must be discussed.

Assume that the offeror will be working with DAIDS PAB, other DAIDS
contractors and more than one DAIDS clinical trials network. Describe
obstacles and problems that might occur and approaches to their
resolution for domestic and resource limited clinical research sites.

**[PHASE III VACCINE CASE STUDY]{.underline}**

-   Study Design: Phase III, randomized, double-blind,
    placebo-controlled, multi-center, prime/boost study

-   Sample Size: 16,000 adult volunteers

-   Duration: 3 years

-   Enrollment Period: 1 ½ years

-   Study Sites: 25 sub-Saharan Africa, 20 in South America and the
    Caribbean, 20 in SE Asia and India, and 80 sites in the US

-   Study Products: Prime vaccine and placebo and Boost vaccine and
    placebo

-   Dosage Form: Injectable

-   Dose Schedule: 0, 1, 3 month for prime and 6 month for boost and
    follow up for 1 year

-   Storage Requirements: Freezer for prime vaccine, refrigerator for
    boost vaccine, room temperature for placebo for prime and boost
    vaccines

-   Expiry/Retest Date: Variable

-   Product Packaging: Single dose vials for the prime and placebo,
    individual syringes for boost vaccine and placebo

-   Product Manufacturers: One of vaccine and placebo manufactured in
    the US and the other vaccine and placebo manufactured in Europe.

**[PHASE IV TREATMENT CASE STUDY]{.underline}**

-   Study Design: Phase IV, randomized, multi-center study to evaluate
    three treatment regimens for the treatment of HIV disease

-   Sample Size: 4,000 HIV-infected adults and adolescents

-   Duration: 3 years

-   Enrollment Period: 1 year

-   Study Sites: 20 in Sub-Saharan Africa, 10 in South America and the
    Caribbean, 10 in SE Asia and India, and 80 sites in the US

-   Study Products: 12 Antiretroviral Agents

-   Dosage Forms: 19 oral dosage forms, mostly solid and some liquid

-   Dose Schedule: Mostly daily, some twice daily

-   Dosing: Weight-based for 3 agents

-   Visit Schedule: Every 4 weeks for 3 months, every 8 weeks thereafter

-   Storage Requirements: Room temperature for most agents, refrigerator
    for some

-   Special Requirement: Product with high alcohol content

-   Expiry Date: Variable by dosage form

-   Manufacturer's Packaging: 1 month supply per bottle for solids, 2
    week supply for liquids, bulk supply for one product

-   Packaging and Labeling Requirements: One product requires labeling
    and one product requires repackaging and labeling