**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-06-06**

**Tri-Service AIDS Clinical Consortium Data Analysis**

**and Coordinating Center (TACC/DACC)**

+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 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     |
| > January 21,  |     |   |   |        |     |   |   |                        |
| > 2005         |   D |   |   |        |     |   |   | > **8(a) Set-Aside:**  |
|                | ate |   |   |        |     |   |   | > \[ \]Yes \[x\] No    |
|                | :** |   |   |        |     |   |   | >                      |
|                |     |   |   |        |     |   |   | > **NAICS:** 541710    |
|                |  Ap |   |   |        |     |   |   | >                      |
|                | ril |   |   |        |     |   |   | > ([See Part IV,       |
|                |     |   |   |        |     |   |   | > Section L](#P).)     |
|                |     |   |   |        |     |   |   |                        |
|                | 21, |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |   2 |   |   |        |     |   |   |                        |
|                | 005 |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                | >   |   |   |        |     |   |   |                        |
|                | **T |   |   |        |     |   |   |                        |
|                | ime |   |   |        |     |   |   |                        |
|                | :** |   |   |        |     |   |   |                        |
|                | > 3 |   |   |        |     |   |   |                        |
|                | :00 |   |   |        |     |   |   |                        |
|                | >   |   |   |        |     |   |   |                        |
|                |  PM |   |   |        |     |   |   |                        |
|                | > , |   |   |        |     |   |   |                        |
|                | >   |   |   |        |     |   |   |                        |
|                | EST |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
|                |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 6.  **Just In  |     | 7 |   |        |     |   | 8 |                        |
|     Time:**    |     | . |   |        |     |   | . |                        |
|                |     |   |   |        |     |   |   |                        |
| > \[x\] No     |     |   |   |        |     |   |   |                        |
| >              |     | * |   |        |     |   | * |                        |
| > \[ \] Yes    |     | * |   |        |     |   | * |                        |
| > (See Part    |     | N |   |        |     |   | T |                        |
| > IV, Section  |     | u |   |        |     |   | e |                        |
| > L.)          |     | m |   |        |     |   | c |                        |
|                |     | b |   |        |     |   | h |                        |
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|                |     | r |   |        |     |   | i |                        |
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|                |     |   |   |        |     |   | a |                        |
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|                |     |   |   |        |     |   |   |                        |
|                |     | o |   |        |     |   |   |                        |
|                |     | f |   |        |     |   |   |                        |
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|                |     |   |   |        |     |   | ( |                        |
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|                |     |   |   |        |     |   | ) |                        |
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|                |     |   |   |        |     |   | a |                        |
|                |     |   |   |        |     |   | - |                        |
|                |     |   |   |        |     |   | b |                        |
|                |     |   |   |        |     |   | y |                        |
|                |     |   |   |        |     |   | t |                        |
|                |     |   |   |        |     |   | e |                        |
|                |     |   |   |        |     |   | s |                        |
|                |     |   |   |        |     |   | ] |                        |
|                |     |   |   |        |     |   | { |                        |
|                |     |   |   |        |     |   | . |                        |
|                |     |   |   |        |     |   | u |                        |
|                |     |   |   |        |     |   | n |                        |
|                |     |   |   |        |     |   | d |                        |
|                |     |   |   |        |     |   | e |                        |
|                |     |   |   |        |     |   | r |                        |
|                |     |   |   |        |     |   | l |                        |
|                |     |   |   |        |     |   | i |                        |
|                |     |   |   |        |     |   | n |                        |
|                |     |   |   |        |     |   | e |                        |
|                |     |   |   |        |     |   | } |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
|                |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 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 |   |                        |
|                |     |   |   |        |     | e |   |                        |
|                |     |   |   | **\[   |     | r |   |                        |
|                |     |   |   | \]     |     | i |   |                        |
|                |     |   |   | Yes**  |     | o |   |                        |
|                |     |   |   |        |     | d |   |                        |
|                |     |   |   |        |     |   |   |                        |
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|                |     |   |   |        |     | 5 |   |                        |
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|                |     |   |   |        |     | 2 |   |                        |
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|                |     |   |   |        |     | # |   |                        |
|                |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 12. Primary    |     |   | 1 |        |     |   |   | 14. **Protest          |
|     Point of   |     |   | 3 |        |     |   |   |     Officer:**         |
|     Contact:   |     |   | . |        |     |   |   |                        |
|                |     |   |   |        |     |   |   | > Program Director,    |
| Name : Barbara |     |   | * |        |     |   |   | > CMP                  |
| Shadrick       |     |   | * |        |     |   |   | >                      |
|                |     |   | S |        |     |   |   | > Address (see Block   |
| **Phone:**     |     |   | e |        |     |   |   | > 9.)                  |
| 301-496-7288   |     |   | c |        |     |   |   |                        |
|                |     |   | o |        |     |   |   |                        |
| **Fax:**       |     |   | n |        |     |   |   |                        |
| 301-402-0972   |     |   | d |        |     |   |   |                        |
|                |     |   | a |        |     |   |   |                        |
| **E-Mail:**    |     |   | r |        |     |   |   |                        |
| [**bs92y@nih.  |     |   | y |        |     |   |   |                        |
| gov**](mailto: |     |   |   |        |     |   |   |                        |
| bs92y@nih.gov) |     |   |   |        |     |   |   |                        |
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|                |     |   | a |        |     |   |   |                        |
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|                |     |   | e |        |     |   |   |                        |
|                |     |   | m |        |     |   |   |                        |
|                |     |   | a |        |     |   |   |                        |
|                |     |   | n |        |     |   |   |                        |
|                |     |   | @ |        |     |   |   |                        |
|                |     |   | 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) |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
|                |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 18\. DELIVERY  |     |   |   |        |     |   |   |                        |
| ADDRESS        |     |   |   |        |     |   |   |                        |
| INFORMATION    |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 19\. Hand      |     |   |   |        | #   |   |   |                        |
| Delivery or    |     |   |   |        | ##  |   |   |                        |
| Overnight      |     |   |   |        | 20. |   |   |                        |
| Service:       |     |   |   |        |  U. |   |   |                        |
|                |     |   |   |        | S.  |   |   |                        |
| Lola Kellum    |     |   |   |        | Pos |   |   |                        |
|                |     |   |   |        | tal |   |   |                        |
| Contract       |     |   |   |        |  Se |   |   |                        |
| Specialist     |     |   |   |        | rvi |   |   |                        |
|                |     |   |   |        | ce  |   |   |                        |
| Contract       |     |   |   |        | or  |   |   |                        |
| Management     |     |   |   |        | an  |   |   |                        |
| Program, DEA   |     |   |   |        | Exp |   |   |                        |
|                |     |   |   |        | res |   |   |                        |
| NIAID, NIH     |     |   |   |        | s D |   |   |                        |
|                |     |   |   |        | eli |   |   |                        |
| 6700-B         |     |   |   |        | ver |   |   |                        |
| Rockledge      |     |   |   |        | y S |   |   |                        |
| Drive, Room    |     |   |   |        | erv |   |   |                        |
| 3214           |     |   |   |        | ice |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
| Bethesda, MD   |     |   |   |        | L   |   |   |                        |
| 20817          |     |   |   |        | ola |   |   |                        |
|                |     |   |   |        | Kel |   |   |                        |
|                |     |   |   |        | lum |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        | Co  |   |   |                        |
|                |     |   |   |        | ntr |   |   |                        |
|                |     |   |   |        | act |   |   |                        |
|                |     |   |   |        | S   |   |   |                        |
|                |     |   |   |        | pec |   |   |                        |
|                |     |   |   |        | ial |   |   |                        |
|                |     |   |   |        | ist |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        | 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 (01/01/2005)

### 

**TABLE OF CONTENTS**

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

[**INTRODUCTION / BACKGROUND**](#B)

[**STATEMENT OF WORK**](#c)

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

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

**[SECTION I \-- GENERAL CLAUSES](#section-i---contract-clauses) and
ADDITIONAL CLAUSES / SUBSTITUTED CLAUSES**

> **[ARTICLE I.1. General Clauses](#section-i---contract-clauses)**

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

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

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

[**SECTION J \-- LIST OF
ATTACHMENTS**](#section-j---list-of-attachments)

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

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

> **OF OFFERORS OR QUOTERS (NEGOTIATED)**

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

> **I**. [**General Information**](#M)
>
> **II. [General Instructions](#N)**

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

**IV. [Business Proposal Instructions](#P)**

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

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

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

**[APPENDIX B](#s) \-- ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS AND
UNIFORM BUDGET ASSUMPTIONS**

[]{#B .anchor}INTRODUCTION / BACKGROUND

**[Introduction]{.underline}**

The Division of Acquired Immunodeficiency Syndrome (DAIDS), National
Institute of Allergy and Infectious Diseases (NIAID), National
Institutes of Health, requests proposals to establish and manage a Data
Analysis and Coordinating Center (DACC) for the Tri-Service AIDS
Clinical Consortium (TACC), hereinafter referred to as the TACC DACC.
The TACC is a multi-site, natural history study of HIV infection
affecting primarily active duty U.S. military personnel and
beneficiaries. The specific objective and scope of the TACC is to
address the critical research questions on the natural and treated
histories of HIV infection to minimize the adverse effects of HIV on the
U.S. military community. The TACC collects medical, laboratory, and
epidemiological data from the cohort to facilitate investigations of the
biology and epidemiology of HIV transmission, factors affecting disease
progression, effectiveness of therapy, and HIV treatment outcomes.

In 2002, the U.S. Military entered into an Interagency Agreement (IAA)
that established a consortium between the Office of Clinical Research at
NIAID and the military centers conducting research involving
HIV-infected military members and their dependents. Under the IAA, a
formal collaborative mechanism was developed, and the TACC was formed. A
governing process for the network was established, consisting of a
Coordinating Team (CT) composed of military investigators and NIAID
scientists. The CT is responsible for the governance of the network,
sets scientific priorities for research, and performs scientific review
of research proposals. Specifically, the TACC CT makes recommendations
on: all scientific, policy and organizational issues concerning
development and implementation of research protocols; structure and
membership of working groups; publications; access to data and interim
data monitoring; and access to biological specimens. The TACC CT has
overall responsibility for ensuring that protocols are conducted in
keeping with high standards of scientific and programmatic achievement
and that adequate mechanisms for systematic assessment of research
quality are in place. In addition, an External Advisory Board (EAB) was
established for the TACC. The EAB, composed of opinion leaders in HIV
research from government and academia, was established for the TACC to
provide additional scientific review of all proposed prospective studies
for the TACC.

The services of a DACC are being sought to enhance the conduct of the
TACC by providing scientific leadership and expertise in epidemiologic
and biostatistical methods that optimize analyses of longitudinal cohort
data. The DACC will provide technical expertise in data collection, data
management and quality assurance to produce a valid and reliable
database for analyses. The DACC will participate in TACC conference
calls, assist in reviews of proposed concepts, and will be expected to
play a dynamic role in interacting with the TACC sites and in helping to
establish priorities and reasonable timelines for study activities, data
analyses, and publications.

The NIAID anticipates awarding one contract for a period of five (5)
years to perform the functions specified in the Statement of Work.

**[Background]{.underline}**

[HIV/AIDS in the U.S. Armed Services and the TACC]{.underline}

Routine HIV screening was initiated in the Armed Services in 1985 and
since that time over 4,450 uniformed personnel have tested positive for
HIV. In the U.S. the rate of HIV infection is lower in the military than
in the general population, i.e., one to two people per 10,000 compared
with 10 to 20 per 10,000, respectively. The three services perform HIV
tests on different schedules, with the Air Force testing every 3 years
and the Army and Navy testing every 2 years. It is estimated that over
95% of personnel in the armed services have been tested in the past two
years. Since untreated HIV infection results in high morbidity and
mortality, service men and women who tested HIV positive early in the
epidemic tended to leave active duty within a few years of diagnosis.
Today, HIV positive personnel identified by routine screening are much
less likely to leave active duty. Only when individuals are unable to
work do they receive medical discharge from active duty. Personnel who
are medically discharged may still receive medical care at active duty
care facilities.

Since homosexual contact and the use of illicit drugs are both cause for
dismissal from the uniformed services, the collection of HIV risk
behavior data in military personnel is extremely difficult. However,
some carefully constructed surveys have found that the majority of HIV
infections are due to homosexual behavior, and high risk heterosexual
contact, in particular with commercial sex workers, is not uncommon. The
military conducts frequent unannounced drug tests and the prevalence of
illicit drug use among active duty personnel is very low.

Despite an active education program, members of the military reflect the
risk profile of young U.S. adults. They are at risk for high levels of
alcohol use, risky sexual contacts, and the resultant sexually
transmitted infections, including HIV. The prevalence of high risk
behaviors and the incidence of sexually transmitted diseases are even
higher at times of deployment. Beginning in 2002, the U.S. military has
had more personnel deployed abroad for longer periods than at any time
since the 1990 Gulf War, potentially increasing the risk of HIV exposure
among personnel.

Research and development efforts of the U.S. Military HIV Research
Program (USMHRP) are aimed at minimizing the adverse effects of HIV on
the U.S. military community. To meet this goal, the TACC focuses on
activities within the U.S. Military HIV Program dealing with the biology
and epidemiology of HIV transmission, and factors affecting disease
progression, therapy effectiveness, and complications due to treatment.
These efforts are conducted at the Tri-Service clinical research sites
located at:

-   Walter Reed Army Medical Center, Washington, D.C.

-   Tripler Army Medical Center, Honolulu, Hawaii

-   Brook Army Medical Center and Wilford Hall Medical Center (Air
    Force), San Antonio, Texas

-   National Naval Medical Center, Bethesda, Maryland

-   U.S. Naval Medical Center, San Diego, California

-   Naval Medical Center, Portsmouth, Virginia

The cornerstone of the U.S. Military HIV Research Program is a
longitudinal natural history study that provides a mechanism for the
collection of comprehensive clinical, epidemiological and historical
data in conjunction with laboratory analyses. The objectives of the
natural history study are to:

(1) collect medical and epidemiological data on HIV-infected individuals
    who are Department of Defense (DoD) health care beneficiaries, with
    an emphasis on evaluating those who remain in active military
    service;

(2) study and develop clinical and laboratory surrogate markers for HIV
    progression;

(3) store serum, plasma, and cells as resources that may eventually
    provide answers to current and future HIV-related research
    questions; and

(4) provide an infrastructure of clinical research personnel, facilities
    and volunteers for the conduct of prospective research studies.

Data collected from the study have been important in defining prognostic
factors for HIV, establishing new treatment paradigms, and defining the
evolution of the U.S. HIV-1 epidemic in healthy young adults.
Approximately 300 major publications have resulted from the work of the
clinical program. The study design establishes systematic, standardized
interval time points for the collection of the natural history data and
phlebotomy samples. Several features make the military cohort unique,
including:

(1) defined seroconversion intervals in many subjects due to
    military-wide routine screening;

(2) absence of social, educational, and economic barriers to health care
    in the military system;

(3) balance of racial demographics of the cohort participants; and

(4) open enrollment to include newly-identified HIV-positive
    individuals.

[History of the TACC Cohort]{.underline}

To meet the primary mission of preventing HIV disease in military
populations, two different protocols were developed in September 1988.
These natural history studies collected medical and epidemiological data
on HIV-infected individuals, principally among active duty personnel,
but also among spouses in the DoD beneficiary pool. The Retrovirus 1
(RV1) protocol, \"Natural History of HIV Infection and Disease in United
States Military Beneficiaries,\" was designed to provide information
based on longitudinal clinical and laboratory data.

The second protocol, RV2 \"Core Protocol for HIV Developmental
Diagnostics,\" used serum, plasma and cell samples to support basic
research on HIV disease and to provide complementary information, such
as the development of clinical and laboratory surrogate markers for HIV
progression. In the late 1990s, radical changes in HIV treatment,
morbidity, and mortality prompted a new study design, RV122 that
consolidated the RV1 and RV2 protocols. During the RV1, RV2, and RV122
studies, 4,400 individuals were enrolled, of which 1,550 are alive and
in active follow-up. The demographics of the cohort reflect the active
duty military, since 43% are between 26 and 35 years of age, 90% are
male, and all have a high school diploma or equivalent.

This is a unique cohort because the population is diagnosed early due to
mandatory HIV testing of the military personnel. For 55% of the cohort,
the time between the last HIV negative test and first positive test is
less than one year, and the first CD4 cell count is greater than 400
cells/mm^3^ for 75% of the cohort. Prompt enrollment soon after
seroconversion has been instrumental in identifying early events and
establishing their role(s) in disease progression and tracking the
evolution of transmission of antiretroviral drug resistance. The cohort
also is unique in its racial and ethnic diversity, and its lack of bias
imposed by economic and social barriers to health care access. All
HIV-positive active duty personnel receive Congressionally mandated
visits every six months to the infectious disease specialty clinic for
their service. RV122 capitalizes on these visits by enrolling and
following consenting personnel. This ensures consistent time intervals
for data and specimen collection and allows for the association of
clinical status, CD4 counts, viral burden, clinical stage, and stored
blood specimens at each visit. In addition, between the required six
month visits, most personnel also receive regular HIV care at the same
clinics. Thus, the RV122 database has access to interim clinic visit
information on consenting participants.

The RV122 study is undergoing a second protocol revision in 2004.
Further standardization of the protocol is planned, along with the
implementation of data capture methods to collect data from other
electronic databases in the U.S. military health system. The RV122
database will incorporate pharmacy data since 1996 and hospitalization
records since 1992 from all consenting personnel. This will provide the
RV122 study unprecedented data quality on therapy and outcomes among
study participants.

These protocols provide the basis from which the interventional
protocols in the Military HIV Research Program have originated.
Interventional research in the military program ranges from studies to
evaluate novel therapeutic drugs or regimens, to biodefense research,
vaccination safety, and troop readiness of HIV-positive personnel.
Clinical trials that recruit consenting participants from the RV122
cohort study have access to the wealth of longitudinal data collected in
the cohort. These data are valuable for determining study eligibility
and for comparing disease progression pre- and post-intervention. Study
participants are experienced with clinical research, have at least a
high school degree, are able to make informed decisions regarding their
participation in clinical research, and are well prepared for full
participation. Furthermore, the balanced racial and ethnic diversity of
the cohort increases the ability to apply study results to populations
not well served by other clinical trial networks.

**SCOPE OF WORK**

This contract will establish a Data Analysis and Coordinating Center
(DACC) for the Tri-Service AIDS Clinical Consortium (TACC), hereinafter
referred to as the TACC DACC.  The TACC is a multi-site, natural history
study of HIV infection affecting primarily active duty U.S. military
personnel and beneficiaries.  The specific objective and scope of the
TACC are to address the critical research questions on the natural and
treated histories of HIV infection to minimize the adverse effects of
HIV on the U.S. military community.  The TACC collects medical,
laboratory, and epidemiological data from the cohort to facilitate
investigations of the biology and epidemiology of HIV transmission and
factors affecting disease progression, the effectiveness of therapy, and
HIV treatment outcomes.  The DACC will enhance the conduct of the TACC
by providing scientific leadership and expertise in epidemiology and
biostatistical methods that optimize analyses of longitudinal HIV cohort
data and fully utilize the network of TACC clinical sites, laboratories
and specimen repositories.  A sound methodological approach to the
measurement of disease incidence, prevalence, and progression, based on
currently used or new surrogate markers, is necessary in several TACC
studies where key events, such as time of HIV seroconversion, are
unknown.  Additionally, the DACC will provide technical expertise in
data collection, data management and quality assurance to produce a
valid and reliable database for analyses.  The DACC will participate in
TACC conference calls, assist in reviews of proposed concepts, and will
interact with the TACC sites to guide the science of HIV research, and
in helping to establish priorities and reasonable timelines for study
activities, data analyses, and publications.  The DACC will interact
with the TACC sites and help establish, through its seat on the TACC
Coordinating Team (CT), scientific priorities and reasonable timelines
for study activities, data analyses, and publications.

[]{#c .anchor}STATEMENT OF WORK

Independently, and not as an agent of the Government, the Contractor
shall furnish all the necessary services, qualified personnel,
materials, equipment, and facilities, not otherwise provided by the
Government under the terms of this contract, as needed to provide the
statistical, technical, administrative and logistical expertise
necessary to support the TACC in the design, implementation, and
analyses of multi-site observational clinical studies. Specifically, the
Contractor shall perform the following functions which are explained in
detail in succeeding sections of this Statement of Work:

1.  Collaboration with the TACC study sites and the TACC Coordinating
    Team (CT)

2.  Initial Data Cleaning, Validation, and Quality Assurance Plan and
    Procedures

3.  Ongoing Data Validation, Data Cleaning, and Quality Assurance

4.  Security Requirements

5.  Cohort Study Support, Training, and Communication

6.  Consultation in Scientific Design and Analytic Strategies

7.  Data Analysis for Retrospective, Prospective, and Collaborative
    Research

8.  Clinical Trials Design and Analytic Support

9.  Medical Reports and Presentations

10. Final Transition of Data and Documentation

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1.  **Collaboration with the TACC study sites and the TACC Research
    Coordinating Team (CT)**

> A key requirement for the effective conduct of a complex study such as
> the TACC is the ability of the CT, the clinical study sites, the TACC
> investigators, and the DACC to work together in a cooperative and
> collegial fashion to accomplish scientific objectives. The objective
> is to have all TACC organizations function as a team. Accordingly, the
> Contractor shall establish effective lines of communications with
> DAIDS, the TACC CT and clinical site personnel and organizations. The
> TACC CT shall establish clear lines of authority and institute
> procedures for overcoming obstacles to effective communication within
> the DACC and among TACC investigators. The DACC will participate in
> the TACC conference calls and will facilitate communications between
> the TACC CT, the NIAID Project Officer and the clinical sites
> regarding TACC plans, procedures, scientific activities, and progress
> through use of the following mechanisms:
>
> a\. Prepare semi-annual statistical reports on the scientific progress
> advancing the knowledge and understanding of HIV infection through
> proposed concepts, approved investigations, data analyses,
> presentations, and publications using the TACC data.

b.  Coordinate scheduled bimonthly conference calls for each of the
    scientific working groups and for the TACC CT. The agenda for each
    call will be pre-arranged by the TACC Principal Investigator or by
    the chair of each specific working group. Additional conference
    calls may be necessary for coordinating the scientific agenda, for
    protocol revisions, for planning meetings, and to address other
    research-related issues.

> c\. Participate with the TACC CT to plan, coordinate and schedule
> bi-annual Meetings.
>
> d\. Utilize electronic mail for quick interaction among TACC
> organizations.
>
> e\. Establish web portal communication among TACC organizations.

2.  **Initial Data Cleaning, Validation, and Quality Assurance Plan and
    Procedures**

> Data Cleaning and Quality Assurance of the TACC database will occur in
> two phases. Under the initial phase, the Contractor will receive raw
> data from the existing TACC HIV-1 Natural History database managed by
> the U.S. Military HIV Research Program (USMHRP). The Contractor shall
> develop and implement a TACC CT-approved plan to clean and perform
> quality assurance procedures on that data. The second and ongoing
> phase of data cleaning and validation is explained in paragraph 3.,
> below. A validated dataset, summary files, and clear documentation of
> cleaning procedures and programming will be returned to the data
> center for the U.S. Military HIV Research Program (USMHRP) within 12
> months of receipt of raw data. In order to secure and manage the
> database during the validation processes, the data shall reside on a
> multiprocessor server with adequate memory and RAM to support complex
> data manipulation and graphical applications as well as working
> directories for use by data center staff and TACC investigators. The
> file system structure shall provide an efficient means of organizing
> all components of the data center activities. Statistical software
> shall include the most recent version of Windows for networking,
> SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/IML, SAS/AF, SAS/FSP, SPlus, and
> other programming capacity for processing, storage, retrieval, and
> multivariable analyses of longitudinal clinical, laboratory, and
> pharmaceutical data for more than 5,000 observations. The Contractor
> shall provide an off-site secured storage facility for system
> back-ups. The database and management system shall be established and
> fully functional within 12 months from the date of contract award. The
> database and data management system shall include:

a.  a comprehensive timeline for data cleaning and validation of the
    existing TACC HIV-1 Natural History database;

b.  strategies to ensure data security, back-ups, and continuity during
    quality assurance procedures and data analyses;

c.  strategies for assessing quality assurance needs as well as
    retrieval and recovery of prior missing enrollee data;

d.  a specimen inventory and monitoring system that links study personal
    identification numbers (PIN) to bar-coded specimens within the
    specimen repository and that follows the selection and use of
    various specimens for specific TACC CT-approved projects;

e.  a schedule for review and revision of operational manuals to reflect
    database structure and revisions;

f.  a review and appropriate revision of the existing protocol for the
    data capture process including schedules of electronic data capture
    and local or centralized direct data entry; and

g.  a strategy and timeline for training local site staff on revisions
    to the data documentation and any changes to the data entry
    protocol.

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3.  **Ongoing Data Validation, Management, and Quality Assurance**

> The subsequent phases of data cleaning and validation shall occur
> concurrent with and at the conclusion of each six-month study visit
> window. The Contractor shall receive raw data from the USMHRP
> datacenter in real time, so that final data validation can begin after
> the conclusion of the six month study visit window. The Contractor
> shall implement CT-approved cleaning and quality assurance procedures
> to establish a validated full dataset and summary files. Validated
> data and all documentation for cleaning and organization, including
> data dictionaries, will be returned to the USMHRP datacenter. Summary
> files will be provided to each TACC clinical center. The Contractor
> shall administer a system for electronic communication, such as a web
> site, that links TACC clinical site investigators, the NIAID Project
> Officer, and the CT to protected shared information. This system shall
> also provide limited public access in order to promote collaboration
> with other HIV researchers, scientists, and investigators.
>
> The Contractor shall develop systems that provide for:

a.  The storage, tracking, retrieval, processing, and transferring of
    validated clinical, laboratory, and mechanistic study data
    integrated at a central data management facility.

b.  Evaluation and implementation, in collaboration with the USMHRP data
    group, of computerized study forms and systems for remote entry and
    secure transmission of participant data from clinical sites to the
    central data management facility.

c.  Computerized validation and error-checking to evaluate and improve
    the accuracy, timeliness and completeness of data submitted by the
    clinical sites, including verification of the clinical and
    laboratory data used to determine that study participants have
    reached defined endpoints.

d.  A study-wide quality assurance and monitoring system that performs
    range and error-checking of clinical, survey, and laboratory data
    from every six-month study visit window and evaluates reliability,
    validity, and completeness of the data. The Contractor shall
    document all quality assurance activities per TACC CT guidelines
    including data evaluations, data cleaning schedules and programs,
    and all data edit. This system shall be capable of producing reports
    and flagging anomalous and missing data. All documentation shall be
    available for annual audits as required by Federal regulations.

e.  A dedicated computerized inventory and distribution system
    documenting requests for data and specimens and programming for all
    data retrievals and analyses.

f.  A secure web site and web-based portal to provide electronic
    communication and promote information-sharing and collaboration
    among clinical study sites, the NIAID Project Officer, the CT and
    the DACC. Within this portal, the Contractor shall create and
    maintain a password-protected, organized, searchable library of each
    proposed concept and manuscript and documentation of subsequent
    reviews.

> []{.mark}

g.  Summary data files for TACC researchers and the NIAID Project
    Officer based upon CT guidelines and a six-month study visit
    schedule.

h.  Integration of the Contractor's information system(s) with the
    relevant components of the Division of AIDS (DAIDS) Enterprise
    System (DAIDS-ES), a comprehensive system that supports the business
    functions, management and oversight responsibilities of the DAIDS.
    The current components of the DAIDS-ES include an adverse event
    reporting system and a protocol management system. To achieve
    DAIDS-ES compatibility, DAIDS and its grantees and contractors will
    implement applications or data exchange mechanisms using DAIDS
    defined platform technology standards.

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4.  **Security Requirements**

> The Contractor shall develop, implement, and maintain security
> requirements, including:

a.  An Automated Information System (AIS) Security Profile, which, at a
    minimum, shall include:

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1)  the Continuity of Operations Plan (COOP), also known as the
    Contingency Plan.

2)  the Risk Analysis (RA); and

3)  the System\'s Security Plan (SSP);

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b.  The development and maintenance of an up-to-date COOP following the
    guidance in DHHS AISSP Handbook
    (<http://irm.cit.nih.gov/policy/aissp.html>). At a minimum, the COOP
    shall cover emergency operations, backup operations, and recovery
    plans to assure continuous operations of the system\'s facility.
    COOP testing shall be conducted and the results recorded at least
    every six months.

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

d.  The preparation and submission, for NIAID Project Officer approval,
    of an RA following the guidance given in DHHS AISSP Handbook
    (http://irm.cit.nih.gov/policy/aissp.html). The RA shall be
    maintained and updated every three years, or in advance of
    implementing major system modifications or enhancements.

e.  The preparation and submission of an annual SSP, following the
    instruction in OMB Bulletin 90-08, for review and approval by the
    NIAID Project Officer and the NIH Information Systems Security
    Officer (ISSO) (http://irm.cit.nih.gov/itmra/omb90-08.html).

f.  Plans, procedures, and a recommended schedule and budget for
    implementation of security safeguards required to satisfy the
    anticipated conditions of acquiring data from clinical and
    mechanistic and biomarker study sites. This includes data integrity
    and security during electronic transmission or during transit from
    the USMHRP data center or from sites to the TACC DACC. All
    participant identifiable data is subject to the Privacy Act and DHHS
    and HIPAA regulations.

g.  Provision for labeling, storage, handling, and disposal of sensitive
    or controlled data, media, and output.

h.  Specifications for a secure web site and web-based portal to provide
    electronic communication and collaboration linkages among clinical
    study sites, the NIAID Project Officer, the CT and the DACC.

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5.  **Cohort Study Support, Training and Communication**

> The Contractor shall provide intellectual input to the TACC in
> establishing priorities and reasonable timelines for study activities,
> and shall collaborate with the CT, NIAID, and other scientists to
> facilitate the achievement of the TACC's research objectives. The
> Contractor shall maintain organized, complete, specific, feasible, and
> ethical study protocols and research initiatives that continue to
> advance the science of HIV infection through clinical trials and
> observational, population-based research and data analyses.
> Specifically, the Contractor shall:

a.  Assess the various components of the operation and management of the
    clinical sites, including: site management, organization and
    utilization of the site staff; communication among clinical,
    technical and administrative staff; and the adequacy of site
    facilities and study equipment.

b.  Coordinate the revision of existing TACC questionnaires as specified
    by the TACC CT to ensure that data collection addresses current
    research on HIV/AIDS. Advise in the development and conduct testing
    of new questionnaires for the TACC.

c.  Prepare and update operations manuals and data collection forms and
    monitor and standardize procedures for all data collection
    activities.

d.  Develop strategies to maintain quality control at each clinical site
    to assure uniform, standardized data collection. Provide
    standardized training for clinical site staff via conference calls
    and meetings.

e.  Delineate specific instructions and requirements necessary for the
    appropriate implementation of study forms for data collection and
    monitoring of clinical site personnel;

f.  Provide travel expenses for DACC personnel associated with group
    meetings with clinical site personnel, when necessary, to ensure
    appropriate training. \[NOTE: Travel for site visits and training of
    site personnel is in addition to the expected travel to semi-annual
    TACC meetings and annual research meetings for reporting scientific
    achievements.\]

g.  Perform site visits in the first 18 months of the contract to each
    study site location (7 total) to observe, evaluate, and modify study
    procedures for efficiency, standardization, and accuracy of study
    procedures and data collection. After the first visit, subsequent
    visits will occur at least once per year per study site.

h.  Perform subsequent annual site visits, or more frequently as deemed
    necessary by the TACC CT and NIAID Project Officer, for the purposes
    of training site staff and conducting a review of interview skills
    and procedures, specimen collection skills and procedures, data
    management, interim data monitoring, and final data analysis and
    interpretation.

i.  Submit post-site visit reports to the TACC CT and the NIAID Project
    Officer within one (1) month of each site visit to ensure that needs
    identified during visits are rapidly addressed.

j.  Provide written and verbal feedback to sites after the completion of
    a 6-month study visit for all areas of study monitoring, including
    recruitment and retention of study participants and completeness and
    validity and reliability of data.

k.  Provide logistical services for arranging all bi-monthly conference
    calls and any additional conference calls required for working
    groups, CT, and other ad hoc committees or study-related groups.

l.  Provide for the incorporation of statistical, clinical, technical
    and administrative expertise, and curtail or discontinue personnel
    and fiscal resources when necessary to accommodate changing
    scientific priorities and opportunities.

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6.  **Consultation in Scientific Design and Analytic Strategies**

> The Contractor shall provide scientific leadership in epidemiology and
> biostatistics to TACC investigators in the development and review of
> cutting edge design and analytic approaches that fully utilize the
> network of TACC clinical sites, laboratories and specimen
> repositories. A sound methodological approach to the measurement of
> disease incidence, prevalence, and progression, based on currently
> used or new surrogate markers, shall be necessary in several TACC
> studies where key events, such as time of HIV seroconversion, are
> unknown. Specifically, the Contractor, in performing its role as the
> DACC, shall provide input into the development, review, and
> implementation of concepts and sub-studies by:

a.  delineating research questions that can be addressed with study
    data, are a priority for the accomplishment of TACC scientific
    objectives, and advance the understanding of HIV infection;

b.  selecting appropriate study populations and control or comparison
    groups to address the research questions;

c.  developing inclusion and exclusion criteria;

d.  defining clinical end-points and immune/surrogate markers;

e.  selecting and developing alternative study designs and data analysis
    plans, including approaches for limited sample size, and delineating
    the compromises that must be made in the face of immutable
    circumstances (e.g., small sample size due to rarity of disease or
    procedure);

f.  assessing the feasibility of accessing appropriate data for
    retrospective analyses and for recruiting and retaining adequate
    numbers of study participants for proposed sub-studies;

g.  designing and developing study forms, including case report forms,
    and informed consent documents; and

h.  assuring that the type, number and volume of participant samples
    required are available and consulting clinical sites on the
    appropriate collection, testing, storage and shipping of participant
    samples.

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7.  **Data Analysis for Retrospective, Prospective, and Collaborative
    Research**

> The Contractor shall conduct data analyses for TACC CT-approved
> concepts and manuscripts. Scientific and analytic support shall
> include instances where the DACC representative is the lead author,
> the DACC supplies full analytic support, or the DACC ensures access to
> data for other TACC collaborators. In addition, the Contractor shall:

a.  provide staff with expertise in the following:

    1.  theoretical statistics;

    2.  epidemiology;

    3.  data modeling, particularly longitudinal data;

    4.  methodologies in controlling for effects of yet optimizing
        repeated measures;

    5.  marginal structural modeling;

    6.  causal inference, including appropriate use of propensity scores
        and instrumental variables; and

    7.  exploratory data analysis and robust methods in determining
        population and person-level effects;

b.  develop *a priori* data analysis plans as well as plans for
    secondary analyses;

c.  develop innovative statistical methods to address scientific
    questions posed by the TACC investigators in light of their focus on
    military readiness and clinical outcomes as well as scientific
    questions posed by approved non-military scientific collaborators;

d.  perform epidemiologic and methodological analyses (as in a. above)
    and develop novel methodological approaches utilizing data from the
    TACC after approval by the TACC CT;

e.  develop specific research databases to be used in proposed concepts;

f.  identify statistical parameters substantiating the choice of
    statistical tests employed in the techniques and methodologies used
    to conduct data analyses;

g.  maintain a tracking system to document the analytic progress and
    status of TACC research proposals;

h.  maintain and distribute to all TACC investigators and the NIAID
    Project Officer, at semi-annual meetings, a list of all
    publications, manuscripts in progress and presentations using data
    from the TACC; and

i.  make drafts of manuscripts available for review (electronically or
    in hard-copy) by the NIAID Project Officer at the time they are
    circulated to co-authors, and when the final manuscripts are
    submitted for publication.

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8.  **Clinical Trials Design and Analytic Support**

> The Contractor shall support the conduct of clinical trials within the
> cohort through:
>
> a\. consultation with TACC clinical investigators and other TACC
> CT-approved research collaborators on protocol development with
> respect to scientific merit;
>
> b\. consultation with TACC clinical investigators and other TACC
> CT-approved research collaborators on feasibility of clinical trials
> implementation;
>
> c\. evaluation and documentation of eligibility of TACC participants
> for specific clinical trials;

d.  the provision of clinical site training to implement the clinical
    trials protocols; and

> e\. coordination with the NIAID Office of Clinical Research which will
> secure Investigational Review Board approval (IRB) for TACC clinical
> trials and will hold the investigational new drug (IND) number for any
> new therapeutics.

9.  **Medical Reports and Presentations**

> The Contractor shall prepare and present semi-annual reports at the
> TACC CT and External Advisory Board meetings. These reports and
> presentations shall include results of data analyses, publications,
> findings of site visits, and recommendations for study procedures. The
> Contractor shall participate in the preparation of scientific
> abstracts and manuscripts for publication and presentation at
> scientific meetings. Such reports shall be approved by the TACC CT and
> the NIAID Project Officer before distribution and shall be of
> sufficiently high editorial quality as to require little, if any,
> additional editing by the NIAID Project Officer.
>
> The Contractor shall submit all abstracts, manuscripts and reviews
> authored and/or co-authored by TACC investigators to the TACC CT and
> the NIAID Project Officer. The Contractor, the CT, and
> co-investigators are required to submit manuscripts to the NIAID
> Project Officer within two weeks of acceptance for publication so that
> an up-to-date summary of program accomplishments can be maintained.
> Publications or oral presentations of work performed under this
> contract are the responsibility of the Contractor and co-investigators
> and shall require appropriate acknowledgement of the US HIV Military
> Research Program and NIAID support.

10. **Final Transition of Data and Documentation**

> The Contractor shall provide a Final Data Transition Plan six months
> prior to the completion date of the contract. The Contractor shall
> submit the written plan in draft to the NIAID Contracting Officer and
> NIAID Project Officer for review and approval to ensure an orderly
> transfer of this project to a subsequent contractor, if other than the
> incumbent, or to the Government. Upon review and comment on the draft
> plan by the NIAID Project Officer, the Contractor shall provide the
> plan in final form, incorporating the comments/changes of the NIAID
> Project Officer.
>
> Should the responsibilities of the DACC be transferred either to a
> successor contractor or to the Government, the Contractor shall
> provide the following deliverables not later than the completion date
> of the contract:

a.  a cleaned and edited public use data set, on media to be determined
    at the time of delivery by the NIAID Project Officer, and copies of
    all data management tools, including data documentation, data
    dictionaries, and data entry software and editing programs to allow
    reading and analysis of the data;

b.  all computer programs used for reading, cleaning, manipulating,
    graphing, and analyzing TACC data and programs used for generating
    new datasets;

c.  an audit trail of all raw data corrections, hard copies of the
    original data collected from study participants from all studies
    supported by this contract, and all logs and other records related
    to data collection, entry, editing, analysis and transfer;

d.  delivery of final summaries of analyses performed by the Contractor
    during the contract period;

e.  transfer of all electronic files in a format that is well documented
    to a location specified by the TACC CT and NIAID Project Officer
    on/before the completion date of the contract; and

f.  transfer all hard copy files in an organized manner, providing clear
    documentation of contents, date of origin, and purpose as specified
    by the TACC CT and NIAID Project Officer, to a location specified by
    the TACC CT and NIAID Project Officer on/before the completion date
    of the contract.

g.  Notwithstanding the potential transfer of this project at its
    conclusion to a successor contractor or to the Government, the
    Contractor shall maintain full operational capacity until the
    completion date of the contract.

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

[]{#D .anchor}**REPORTING REQUIREMENTS**

**Scientific and Technical Reports**

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

The Contractor shall submit to the NIAID Contracting Officer and to the
Project Officer technical and scientific progress reports covering the
work accomplished during each Semi-annual reporting period. In addition,
the Contractor shall submit an Annual Automated Information System
Security Report. These reports shall be factual and prepared in
accordance with the format specified below.

**1. Semiannual Scientific and Statistical Report**

> This report shall summarize the results during the reporting period,
> and shall be in sufficient detail to explain comprehensively the
> results achieved. The initial report will be submitted for the first
> full six months of the contract performance including any fractional
> part of the initial month. Thereafter, the reporting period shall
> consist of six full calendar months.
>
> The first report shall be due . Thereafter, reports shall be due on or
> before the 30^th^ of the month following each reporting period.
>
> The original of this report shall be provided to the Contracting
> Officer, one copy to the Project Officer and one copy to the TACC
> Coordinating Team (CT). A Semi-annual Report is not required for the
> period when the Final Report is due.
>
> The report shall summarize the status of the following Consortium
> activities, including:

a\) Statistical Design Considerations

1)  Summary of proposed clinical concepts, publications, and status of
    ongoing analyses. This shall include: Title, author(s), brief
    description and status of approved analyses, including any pending
    issues, problems or modifications; and recommendations;

2)  The advantages and disadvantages of the various approaches to the
    statistical design of proposed concepts and manuscripts; and

3)  Recommendations for improved statistical approaches and methods to
    enhance the ability to assess disease stage and activity,
    therapeutic effect and underlying mechanisms.

> b\) Scientific Results and Publications, including:

1.  Listing of studies initiated, ongoing, and completed in the previous
    six month period;

2.  Summary of interim and final analyses performed;

3.  Presentations of study progress and results given at local,
    national, and international scientific meetings, including
    electronic files of slide presentations used; and

4.  Listing and reprints/preprints of all published/submitted abstracts
    and manuscripts.

> c\) Standard Operating Procedures, including:

1.  Development, review and implementation of protocol(s), including
    criteria for evaluation and prioritization;

2.  Preparation, review and approval of requests for statistical
    analyses;

3.  Review and approval of publications, abstracts, reports and
    presentations; and

4.  Developing other policies and procedures in conjunction with the
    TACC CT.

> d\) Clinical Site Training, including:

1)  A summary of issues or problems encountered with respect to the
    staff training, decision-making processes, including recommendations
    for modifications and improvements to enhance the timeliness,
    efficiency or thoroughness of study conduct; and

2)  All reports from clinical site visits, including documentation of
    site capabilities and deficiencies and remedies implemented to
    assure the sites are in compliance with all appropriate study
    procedures.

**2. Annual Automated Information System Security Report**

> The Contractor shall provide an Annual Automated Information System
> Security Report including the Automated Information System (AIS)
> Security Profile which, at a minimum, shall include:

-   System\'s Security Plan (SSP);

-   Risk Analysis (RA);

-   Continuity of Operations Plan (COOP also known as the Contingency
    Plan); and

-   Progress on adaptation of the study management data to conform to
    the Division of AIDS Enterprise System (DAIDS-ES).

> The first report shall cover the period through of this contract and
> shall be due on/before . Thereafter, reports shall be due on or before
> the 30^th^ of the month following each anniversary date of the
> contract. This report is not required for the period when the Final
> Report is due.

**3**. **Final Technical Report and Summary of Salient Results**

> The Final Technical Report shall summarize all Contractor activities
> for the life of the contract and all final study results and interim
> results from unfinished studies or analyses and shall be due on/before
> the completion date of the contract. All study reports shall include
> the enrollment and retention statistics by clinical site. The
> Contractor shall submit, with the Final Report, a summary (not to
> exceed 200 words) of salient results detailing the important
> accomplishments achieved during the performance of the contract.

**4**. **Other Deliverables**

> On/before the completion date of the contract, the Contractor shall
> deliver to the Government the following items:
>
> a\) A cleaned and edited public use data set, as specified in SOW,
> paragraph 10, "Final Transition of Data and Documentation"; and per
> specifications for the DAIDS-ES;
>
> b\) An audit trail of all raw data corrections and data transfers, and
> all logs and other records related to data validation, editing,
> analysis - including all well-documented SAS -compatible analytic
> statistical programs.

**5**. **Technical Report Distribution**

+---+-------------------------+-----------------+--------------------+
| * | **Deliverable**         | **Quantity**    | **Due Date**       |
| * |                         |                 |                    |
| I |                         |                 |                    |
| t |                         |                 |                    |
| e |                         |                 |                    |
| m |                         |                 |                    |
| * |                         |                 |                    |
| * |                         |                 |                    |
+---+-------------------------+-----------------+--------------------+
| 1 | Semiannual Status and   | Original --     | 1^st^ Report due   |
| \ | Statistical Report      | C.O.            | on/before          |
| . |                         |                 | \_\_\_\_\_\_\_\_;  |
|   |                         | 2 Copies --     | thereafter, due    |
|   |                         | P.O.            | on/before the      |
|   |                         |                 | 30^th^ of the      |
|   |                         | 1 Electronic    | month following    |
|   |                         | Copy -- P.O.    | each reporting     |
|   |                         |                 | period. Not due    |
|   |                         | 1 Copy -- TACC  | when Final is due. |
|   |                         | CT              |                    |
+---+-------------------------+-----------------+--------------------+
| 2 | Annual Automated        | Original --     | 1^st^ Report due   |
| \ | Information System      | C.O.            | on/before          |
| . | Security Report         |                 | \_\_\_\_\_\_\_\_;  |
|   |                         | 2 Copies --     | thereafter, due    |
|   |                         | P.O.            | on/before the      |
|   |                         |                 | 30^th^ of the      |
|   |                         | 1 Electronic    | month following    |
|   |                         | Copy -- P.O.    | each anniversary   |
|   |                         |                 | date of the        |
|   |                         |                 | contract. Not due  |
|   |                         |                 | when Final is due. |
+---+-------------------------+-----------------+--------------------+
| 3 | Final Technical Report  | Original --     | Due on/before the  |
| \ | and Summary of Salient  | C.O.            | completion date of |
| . | Results                 |                 | the contract.      |
|   |                         | 2 Copies --     |                    |
|   |                         | P.O.            |                    |
|   |                         |                 |                    |
|   |                         | 1 Electronic    |                    |
|   |                         | Copy -- P.O.    |                    |
+---+-------------------------+-----------------+--------------------+
| 4 | Clean/edited public use | Project Officer | On/before the      |
| \ | data set (see paragraph |                 | completion date of |
| . | 4.a), above).           |                 | the contract.      |
+---+-------------------------+-----------------+--------------------+
| 5 | Computer programs for   | Project Officer | On/before the      |
| \ | reading and             |                 | completion date of |
| . | manipulating data, and  |                 | the contract.      |
|   | creating SAS compatible |                 |                    |
|   | files.                  |                 |                    |
+---+-------------------------+-----------------+--------------------+
| 6 | Audit Trail of all raw  | Project Officer | On/before the      |
| \ | data corrections, hard  |                 | completion date of |
| . | copies, etc. (see       |                 | the contract.      |
|   | paragraph 4.b), above). |                 |                    |
+---+-------------------------+-----------------+--------------------+

6.  **Addressees**

> Project Officer Contracting Officer
>
> BSP, DAIDS, NIAID CMP, DEA, NIAID
>
> 6700-B Rockledge Drive, Room \_\_\_\_ 6700-B Rockledge Drive, Room
> 3214
>
> MSC 7626 MSC 7612
>
> Bethesda, MD 20892-7626 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

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.

**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**

[]{#G .anchor}

**ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES**

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

**ITEM 13:** FAR Clause **52.232-20, Limitation of Cost**, is deleted in
its entirety and FAR Clause **52.232-22, Limitation of Funds** (APRIL
1984) is substituted therefor. \[Note: When this contract is fully
funded, FAR Clause **52.232-22, Limitation of Funds** will no longer
apply and FAR Clause **52.232-20, Limitation of Cost** will become
applicable.\]

See **I.2 Authorized Substitutions of Clauses** of SECTION I at
<http://rcb.cancer.gov/rcb-internet/wkf/sectioni.pdf> for the general
listing of Authorized Substitutions of Clauses.

### ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES

## 52.204-8 Annual Representations and Certifications (Jan 2005). 

(a)(1) If the clause at 52.204-7, Central Contractor Registration, is
included in this solicitation, paragraph (b) of this provision applies.
(2) If the clause at 52.204-7 is not included in this solicitation, and
the offeror is currently registered in CCR, and has completed the ORCA
electronically, the offeror may choose to use paragraph (b) instead of
completing the corresponding individual representations and
certifications in the solicitation. The offeror shall indicate which
option applies by checking one of the following boxes:

\[ \] (i) Paragraph (b) applies.

\[ \] (ii) Paragraph (b) does not apply and the offeror has completed
the individual representations and certifications in the solicitation.

\(b\) The offeror has completed the annual representations and
certifications electronically via the Online Representations and
Certifications Application (ORCA) website at
[http://orca.bpn.gov](http://orca.bpn.gov/). After reviewing the ORCA
database information, the offeror verifies by submission of the offer
that the representations and certifications currently posted
electronically have been entered or updated within the last 12 months,
are current, accurate, complete, and applicable to this solicitation
(including the business size standard applicable to the NAICS code
referenced for this solicitation), as of the date of this offer and are

incorporated in this offer by reference (see FAR 4.1201); except for the
changes identified below [\[offeror to insert changes, identifying
change by clause number, title, date\]]{.mark}. These amended
representation(s) and/or certification(s) are also incorporated in this
offer and are current, accurate, and complete as of the date of this
offer.

Any changes provided by the offeror are applicable to this solicitation
only, and do not result in an update to the representations and
certifications posted on ORCA.

(End of provision)

**ITEM 39:** FAR Clause **52.219-23, Notice of Price Evaluation
Adjustment for Small Disadvantaged Business Concerns** (JUNE 2003), is
applicable to this solicitation.

ITEM 50: FAR Clause 52.227-14, Rights in Data\--General (JUNE 1987).

See **I.3 Additional Contract Clauses of** SECTION I at
<http://rcb.cancer.gov/rcb-internet/wkf/sectioni.pdf> for the general
listing of Additional Contract Clauses.

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

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

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

## SECTION J - LIST OF ATTACHMENTS

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

[PACKAGING AND DELIVERY OF PROPOSALS](#W)

[HOW TO PREPARE AN ELECTRONIC PROPOSAL](#X)

[PROPOSAL INTENT RESPONSE SHEET](#Y) \[SUBMIT ON/BEFORE: March 15,
2005\]

> \[NOTE: Your attention is directed to the \"Proposal Intent Response
> Sheet\". If you intend to submit a proposal, you must complete this
> form and return it to this office via fax or e-mail on or before the
> date identified above. The receipt of this form is critical as it
> contains information essential for CMP's coordination of the
> electronic submission and review of proposals.\]
>
> **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)}

### Optional Form 310, Protection of Human Subjects Assurance Identification/Certification/Declaration \[When applicable, all institutions must have the form reviewed and approved by their Institutional Review Committee.\] {#optional-form-310-protection-of-human-subjects-assurance-identificationcertificationdeclaration-when-applicable-all-institutions-must-have-the-form-reviewed-and-approved-by-their-institutional-review-committee. .Normal-Bold-(bullet)}

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

-   **Targeted/Planned Enrollment Table**

```{=html}
<!-- -->
```
-   **Information Technology Systems Security - Prospective Offeror
    Non-Disclosure Agreement**

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 [(must be submitted with your original Business Proposal)]{.mark} {#small-business-subcontracting-plan-format-must-be-submitted-with-your-original-business-proposal .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):

-   **Inclusion Enrollment Report**

### 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)}

### Privacy Act System of Records {#privacy-act-system-of-records .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)}

[]{#W .anchor}PACKAGING/DELIVERY/ELECTRONIC SUBMISSION OF THE PROPOSAL

Please refer to
[**http://www.niaid.nih.gov/contract/eproposal.htm**](http://www.niaid.nih.gov/contract/eproposal.htm)
for delivery instructions for the submission of both PAPER and
ELECTRONIC COPIES of your proposal.

[PAPER SUBMISSION]{.underline}: The paper copy is the official copy for
recording timely receipt of proposals.

[ELECTRONIC SUBMISSION]{.underline}: In addition to the paper
submission, you are requested to submit your proposal electronically
through the CRON (Contracts Review Online) in accordance with the
instructions provided at the above-referenced weblink. [You must certify
that both the original paper and electronic versions of the proposal are
identical]{.underline}.

The electronic submission is solely for the benefit of the Agency. Such
submission is still in a \"test\" stage, and the electronic submissions
may or may not be utilized, at the sole discretion of the Agency.

[SUBMISSION OF PROPOSALS BY FACSIMILE IS NOT ACCEPTABLE]{.underline}.
\-- [SUBMISSION OF ONLY ELECTRONIC PROPOSALS WITHOUT PAPER COPIES IS NOT
ACCEPTABLE.]{.underline}

**WARNING: You are advised to read and carefully follow the instructions
listed in this RFP. Failure to adhere to these instructions and to the
specified limitations for size of paper and electronic proposals may
result in the rejection of your proposal.**

[**NUMBER OF COPIES:**]{.underline}

+-------------------+-----------------------+---------------+---------+
| Document          | Number of Copies      | Page Limits   | **File  |
|                   |                       |               | Size**  |
+-------------------+-----------------------+---------------+---------+
| Technical         | One (1) unbound       | Limited to    | Limited |
| Proposal          | SIGNED ORIGINAL.      | not-to-exceed | to      |
|                   |                       | **[150]{      | not-to  |
|                   | One (1) unbound COPY  | .underline}** | -exceed |
|                   |                       | **[pages]{.   | 5       |
|                   | Twenty (20) bound     | underline}**. | meg     |
|                   | copies.               |               | a-bytes |
+-------------------+-----------------------+---------------+---------+
| Technical         | One (1) unbound       | This          | N/A     |
| Proposal          | SIGNED ORIGINAL.      | information   |         |
| Appendices        |                       | is included   |         |
|                   | One (1) unbound COPY  | in the total  |         |
| All materials not |                       | page          |         |
| available         | Twenty (20) bound     | limitation of |         |
| electronically    | copies.               | 150 pages.    |         |
| (i.e. SOPs,       |                       |               |         |
| Pertinent         |                       |               |         |
| Manuals,          |                       |               |         |
| Nonscannable      |                       |               |         |
| Figures or Data,  |                       |               |         |
| and Letters of    |                       |               |         |
| Colla             |                       |               |         |
| boration/Intent). |                       |               |         |
+-------------------+-----------------------+---------------+---------+
| Business Proposal | One (1) unbound       | Limited to    | Limited |
|                   | SIGNED ORIGINAL.      | not-to-exceed | to      |
|                   |                       | 150 pages     | not-to  |
|                   | One (1) unbound COPY  |               | -exceed |
|                   |                       |               | 5       |
|                   | Ten (10) bound        |               | meg     |
|                   | copies.               |               | a-bytes |
+-------------------+-----------------------+---------------+---------+
| Representations   | Provide               | N/A           | N/A     |
| and               | representations and   |               |         |
| Certifications    | certifications        |               |         |
|                   | electronically via    |               |         |
|                   | the BPN website       |               |         |
|                   | ([w                   |               |         |
|                   | ww.bpn.gov/orca](http |               |         |
|                   | ://www.bpn.gov/orca)) |               |         |
+-------------------+-----------------------+---------------+---------+
| All offerors are  |                       | Technical     |         |
| required to       |                       | Proposal: 2   |         |
| submit three (3)  |                       | Compact Discs |         |
| CDs that contain  |                       | (CDs)         |         |
| electronic        |                       |               |         |
| versions of all   |                       | Business      |         |
| proposal          |                       | Proposal: 1   |         |
| information (both |                       | Compact Disc  |         |
| technical and     |                       | (CD)          |         |
| business --       |                       |               |         |
| clearly marked).  |                       |               |         |
| If information    |                       |               |         |
| appended to the   |                       |               |         |
| paper version is  |                       |               |         |
| not available     |                       |               |         |
| electronically,   |                       |               |         |
| the CD shall      |                       |               |         |
| contain a file    |                       |               |         |
| listing all       |                       |               |         |
| documents that    |                       |               |         |
| are submitted in  |                       |               |         |
| paper format      |                       |               |         |
| only. **The       |                       |               |         |
| offeror shall     |                       |               |         |
| include           |                       |               |         |
| certification     |                       |               |         |
| that the          |                       |               |         |
| documents         |                       |               |         |
| provided          |                       |               |         |
| electronically    |                       |               |         |
| match the paper   |                       |               |         |
| version of those  |                       |               |         |
| same documents.** |                       |               |         |
+-------------------+-----------------------+---------------+---------+

**TECHNICAL PROPOSAL PAGE LIMITS INCLUDE**: Appendices, Attachments,
Operating Manuals, Non-Scannable Figures or Data, Letters of Intent,
etc..

**TOTAL PAGE COUNT DOES [NOT]{.underline} INCLUDE**: 1 Cover and Back
Page; 1 Table of Contents; Section Dividers that do not contain
information other than title of Section.

**ANY PORTIONS OF YOUR PROPOSAL NOT AVAILABLE ELECTRONICALLY ARE ALSO
CONSIDERED TO BE INCLUDED IN THE TOTAL PAGE LIMITATION.**

**PAGES IN EXCESS OF THIS LIMITATION WILL BE REMOVED FROM THE PROPOSAL
AND WILL NOT BE PROVIDED TO THE REVIEWERS TO BE READ OR EVALUATED.**

[]{#X .anchor}HOW TO PREPARE AND SUBMIT AN ELECTRONIC PROPOSAL

**[ELECTRONIC SUBMISSION]{.underline}** -- To submit a proposal
electronically under this RFP, offerors will need to prepare the
proposal on a word processor or spreadsheet program (for the business
portion) and convert them to Adobe Acrobat Portable Document Format
(.pdf). THE TECHNICAL PROPOSAL AND BUSINESS PROPOSAL MUST BE CONTAINED
ON SEPARATE FILES which must be identified as either TECHNICAL or
BUSINESS and include some recognizable portion of the ORGANIZATION NAME.

Please note that the electronic submission does not replace the
requirement to submit a signed, unbound original paper copy of both your
Technical and Business Proposal, along with any required unbound
duplicate copies. These paper originals should be mailed or
hand-delivered to the address provided in Box 18 of the RFP cover page
and must be received on/before the closing date and time.

For purposes of assessing compliance with the page count, technical
proposals will be viewed using the print function of the Adobe Acrobat
Reader, Version 4.0 (or higher).

**[Formatting Requirements:]{.underline}**

-   Do not embed sound or video (e.g., MPEG) files into the proposal
    documents. The evaluation system does not have the capability to
    read these files.

-   Documents must be converted to a .pdf searchable format.

-   Keep graphics embedded in documents as simple as possible. Complex
    graphics require longer periods for the computers used in the
    evaluation system to draw, and redraw these figures and scrolling
    through the document is slowed significantly.

-   Type density and size must be 10 to 12 points. If constant spacing
    is used, there should be no more than 15 cpi, whereas proportional
    spacing should provide an average of no more than 15 cpi. There must
    be no more than six lines of text within a vertical inch. Margins
    must be set to 1 inch around.

-   Paper size should not exceed 8-1/2 x 11. Larger paper sizes will be
    counted as 2 pages.

-   Limit colors to 256 colors at 1024 x 768 resolution; avoid color
    gradients.

-   Simplify the color palette used in creating figures.

-   Be aware of how large these graphics files become. Large files are
    discouraged.

-   Pages printed front-to-back will count as 2 pages.

-   Pages may not be printed in column format.

-   Limit scanned images as much as possible.

-   Limit appendices and attachments to relevant technical proposal
    information (e.g., SOPs, pertinent manuals, non-scannable figures or
    data, resumes, letters of commitment/intent).

**[SUBMISSION OF "PROPOSAL INTENT RESPONSE SHEET"]{.underline}:**

**Upon receipt by the Contracting Officer of the "Proposal Intent
Response Sheet", offerors will be provided, via e-mail correspondence,
specific electronic access information and electronic proposal
transmission instructions.** For this reason, it is imperative that all
offerors who are intending to submit a proposal in response to this RFP
contact the Contract Specialist identified in this RFP and complete and
submit the attached "Proposal Intent Response Sheet" by the date
provided on that Attachment.

**[CREATE ADOBE PDF ONLINE]{.underline}** \-- Adobe will allow you to
create 5 documents on a trial for free. If you want to use the site
regularly it costs \$10/month or \$100/year. Please link to the
following URL for information:

<https://createpdf.adobe.com/index.pl/3847995518.39272?BP=IE>

**[LOG-IN / TRANSMISSION INSTRUCTIONS]{.underline}:**

1\. [Log-in Site]{.underline}: Will be provided by the Contract
Specialist after receipt of the"Proposal Intent Response Sheet"

2\. [Log-in Name]{.underline}: Will be provided by the Contract
Specialist via e-mail.

3\. [Log-in Password]{.underline}: Will be provided by the Contract
Specialist via e-mail.

4\. [Procedure]{.underline}: When your proposal is completed and
converted to a PDF file using Adobe Acrobat, it is ready to be

> transmitted electronically. You must upload separate Technical and
> Business Proposal Files. It is recommended that proposals be
> transmitted a few days before the due date so that you will have
> sufficient time to overcome any transmission difficulties.

-   You must have Explorer 3.1 or higher.

-   It is essential that you use antiviral software to scan all
    documents.

-   Click on "Sign On" and enter your log-in name and password.

-   Click on "Browse" to locate your saved files on your computer.

-   Click on "Upload Proposal" after you have located the correct file.

-   After a file is uploaded, a link to the file will appear under
    "Upload Files" at the bottom of the screen. Click on that link to
    view the uploaded file.

-   If you experience difficulty in accessing your documents, please
    contact the appropriate NIH contracts office immediately.

-   If you wish to revise your proposal before the closing date and
    time, simply log in again and re-post.

USER ACCESS TO THE POSTING SITE WILL BE DENIED AFTER THE RFP CLOSING
DATE AND TIME PROVIDED WITH THIS RFP OR ITS MOST RECENT AMENDMENT(S).

> []{#Y .anchor}**PROPOSAL INTENT RESPONSE SHEET**
>
> **RFP No.:** NIH-NIAID-DAIDS-06-06
>
> **RFP Title:** "Tri-Service AIDS Clinical Consortium Data Analysis and
> Coordinating Center (TACC/DACC)"
>
> Please review the attached Request for Proposal. Furnish the
> information requested below and return this page by
>
> [March 15, 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: Barbara Shadrick
>
> RFP-NIH-NIAID-DAIDS-06-06
>
> FAX# (301) 402-0972
>
> Email : <bs92y@nih.gov>

# 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.

ORCA is part of the Business Partner Network (BPN) which is a component
of the Integrated Acquisition Environment (IAE) E-Gov initiative. It is
a web-based system that centralizes and standardizes the collection,
storage and viewing of many of the FAR required representations and
certifications previously found in solicitations. With ORCA, you now
have the ability to enter and maintain your representation and
certification information, at your convenience, via the Internet at
[http://orca.bpn.gov](http://orca.bpn.gov/). In addition, rather than
receiving and reviewing paper submissions, government contracting
officials can access ORCA and review your information online as a part
of the proposal evaluation process. You will no longer be required to
submit representations and certifications completed in ORCA with each
offer.

The final rule requires offerors to: (a)  provide representations and
certifications electronically via the BPN website
([www.bpn.gov/orca](http://www.bpn.gov/orca)) thus reducing the
administrative burden on vendors who have been submitting the same reps
and certs repeatedly for various solicitations,  (b) to maintain the
representations and certifications at least annually so they stay
current, (c) to make changes that affect only one solicitation by
completing sections of specific provisions that are required by the FAR,
included in the solicitation. This will result in a reduced paperwork
burden for both offerors and contracting officers thus fulfilling one of
the goals of IAE to re-use data as much as possible throughout the
Federal procurement life cycle.

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.

IF YOU INTEND TO SUBMIT A PROPOSAL, YOU MUST COMPLY WITH THE ABOVE
REQUIREMENT.

## 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>**

[]{#M .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.**
However, the Federal Acquisition Regulation (FAR) requires in every
solicitation, (except for foreign acquisitions) the inclusion of the
North American Industry Classification System (NAICS) Code and
corresponding size standard which best describes the nature of the
requirement in the solicitation.

**ITEM 11:** In accordance with FAR Clause 52.219-23, Notice of Price
Evaluation Adjustment for Small Disadvantaged Business Concerns,
incorporated in Section I.3., offerors will be evaluated by adding a
factor of *\[percentage to be identified in the specific RFP\]* percent
to the price of all offers, except offers from small disadvantaged
business concerns that have not waived the adjustment. (Note: A listing
of other offerors who are excepted and will not have this evaluation
factor added to their offer may be found in subparagraph (b) of FAR
Clause 52.219-23.

> A small disadvantaged business concern may elect to waive the
> adjustment, in which case the factor will be added to its offer for
> evaluation purposes. The agreements in paragraph (d) of FAR Clause
> 52.219-23 do not apply to offerors that waive the adjustment.
>
> **AN OFFEROR WHO ELECTS TO WAIVE THIS EVALUATION ADJUSTMENT MUST
> SPECIFICALLY INDICATE WITH A STATEMENT TO THIS EFFECT ON THE COVER
> PAGE OF ITS BUSINESS PROPOSAL.**

ITEM 12: 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 [December 15, 2005]{.underline}.

It is anticipated that the award(s) from this solicitation will be a
multiple-year, cost-reimbursement, completion type contract, with a
period of performance of five (5) years, and that incremental funding
will be used \[see Section L, PART IV - Business Proposal
Instructions\].

ITEM 14: 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 [9.5 full time
equivalents (FTEs)]{.underline}. This information is furnished for the
offeror\'s information only and is not to be considered restrictive for
proposal purposes.

ITEM 17: COMPARATIVE IMPORTANCE OF PROPOSALS

You are advised that paramount consideration shall be given to the
evaluation of technical proposals. All evaluation factors other than
cost or price, when combined, are significantly more important than cost
or price. The relative importance of the evaluation factors 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:** **SERVICE OF PROTEST** (AUGUST 1996) - FAR 52.233-2

> \(a\) Protests, as defined in section 33.101 of the Federal
> Acquisition Regulation, that are filed directly with an agency, and
> copies of any protests that are filed with the General Accounting
> Office (GAO), shall be served on the Contracting Officer (*Complete
> address and contact information can be found on the SECTION A
> SOLICITATION/CONTRACT FORM cover page, Blocks 9 & 15, of the specific
> RFP*) by obtaining written and dated acknowledgment of receipt from:
>
> \(b\) The copy of any protest shall be received in the office
> designated above within one day of filing a protest with the GAO.

ITEM 21: LATE PROPOSALS AND REVISIONS, HHSAR 352.215-70, is applicable
to this solicitation.

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

ITEM 24: Potential Award Without Discussions, is applicable to this
solicitation.

ITEM 30: Sharing Research Data, is applicable to this solicitation.

**ITEM 32:** **Specific Copyright Provisions Applicable to Software
Development and/or Enhancements**, is applicable to this solicitation.

ITEM 34: Small Business Subcontracting Plan, is applicable to this
solicitation and the following information is provided to supplement
this item to assist in proposal preparation. A Subcontracting Plan must
be submitted with the original proposal and will be subject to
negotiations if your proposal is determined to be in the competitive
range. The anticipated minimum subcontracting goals for this RFP are as
follows:

-   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 36: Extent of Small Disadvantaged Business Participation, is
applicable to this solicitation.

ITEM 37: Salary Rate Limitation in Fiscal Year 2005, will be applicable
to this solicitation.

ITEM 40: 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:** Electronic and Information Technology Accessibility, is
applicable to this solicitation.

ITEM 49: Prohibition on Contractor Involvement with Terrorist
Activities, is applicable to this solicitation.

ITEM 50: 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 52: Project Objectives, NIH-1688-1, is applicable to this
solicitation.

**ITEM 54: Human Subjects**, is applicable to this solicitation.

**ITEM 55:** **Information Technology Systems Security**, is applicable
to this solicitation.

### 

### 

### *IV. BUSINESS PROPOSAL INSTRUCTIONS*

[]{#P .anchor}

ITEM 57: Proposal Cover Sheet, is applicable to this solicitation.

ITEM 60: Cost and Pricing Data is applicable to this solicitation.

> Subparagraph 3. Formats for Submission of Line Item Summaries:
>
> \[x\] The format specified in SECTION L at
> [**http://rcb.cancer.gov/rcb-internet/wkf/sectionl.pdf**](http://rcb.cancer.gov/rcb-internet/wkf/sectionl.pdf)
> is applicable to
>
> this solicitation.

ITEM 61: Requirements for Cost or Pricing Data or Information Other than
Cost and Pricing Data \[FAR Clause 52.215-20 (October 1997)\], is
applicable to this solicitation.

ITEM 66: Incremental Funding, is applicable to this solicitation.

## SECTION M - EVALUATION FACTORS FOR AWARD

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,
> cost/price, past performance and SDB Participation 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 Contractors in relation to the needs of the project as set
> forth in the RFP. The merits of each proposal will be evaluated
> carefully. Each proposal must document the feasibility of successful
> implementation of the requirements of the RFP. Offerors must submit
> information sufficient to evaluate their proposals based on the
> detailed criteria listed below.

2\. HUMAN SUBJECT EVALUATION

> This research project [may]{.underline} involve human subjects. NIH
> Policy requires:

a.  **Protection of Human Subjects from Research Risks**

> The offeror's proposal must address the involvement of human subjects
> and protections from research risk relating to their participation, or
> provide sufficient information on the research subjects to allow a
> determination by Institute that a designated exemption is appropriate.
>
> If you claim that this research should be considered exempt from
> coverage by the Federal Regulations at 45 CFR 46, the proposal should
> address why you believe it is exempt, and under which exemption it
> applies.
>
> The reviewers will evaluate the proposal and provide a narrative with
> regard to four issues: Risks to Human Subjects, Adequacy of Protection
> Against Risks, Potential Benefits of the Proposed Research to the
> Subjects and Others, and Importance of the Knowledge to be Gained. See
> Section L for a complete discussion of what is required to be
> addressed for each of these issues. Based on the response to this
> criterion, this section of the proposal may be rated "unacceptable"
> (i.e., concerns are identified as to the protections described against
> risk to human subjects or no discussion is found regarding protections
> against risk to human subjects) or "acceptable".
>
> If your discussion regarding the protection of human subjects from
> research risks is rated "unacceptable" and the Government includes
> your proposal in the competitive range (for competitive proposals), or
> if the Government holds discussions with the selected source (for sole
> source acquisitions), you will be afforded the opportunity to further
> discuss and/or clarify your position during such discussions and in
> your Final Proposal Revision (FPR). If, after discussions, your
> proposed plan for the protection of human subjects from research risks
> is still found unacceptable, your proposal may not be considered
> further for award.

a.  **Data and Safety Monitoring**

> The offeror's proposal must include a general description of the Data
> and Safety Monitoring Plan for all clinical trials. The principles of
> data and safety monitoring require that all biomedical and behavioral
> clinical trails be monitored to ensure the safe and effective conduct
> of human subjects research, and to recommend conclusion of the trial
> when significant benefits or risks are identified or if it is unlikely
> that the trial can be concluded successfully. Risks associated with
> participation in research must be minimized to the extent practical
> and the method and degree of monitoring should be commensurate with
> risk. Additionally, all plans must include procedures for adverse
> event reporting. Finally, generally, for Phase III clinical trials,
> the establishment of a Data and Safety Monitoring Board (DSMB) is
> required, whereas for Phase I and II clinical trials, the
> establishment of a DSMB is optional. The reviewers should refer to the
> Statement of Work and Section L in the solicitation, as well as any
> further technical evaluation criteria in this Section M, as
> applicable, for the solicitations specific requirements for data and
> safety monitoring.
>
> As a part of the evaluation for proposals, the reviewers will provide
> a narrative that describes the acceptability of the proposed data and
> safety monitoring plan with respect to the potential risks to human
> participants, complexity of study design, and methods for data
> analysis. Based on the evaluation of the response to this criterion,
> this section of the proposal may be rated "unacceptable" (i.e.,
> concerns are identified as to the adequacy of the monitoring plan or
> no discussion can be found regarding the proposed monitoring plans) or
> "acceptable."
>
> If the information provided regarding Data and Safety Monitoring is
> rated "unacceptable" and the Government includes your proposal in the
> competitive range (for competitive proposals), or if the Government
> holds discussions with the selected source (for sole source
> acquisitions), you will be afforded the opportunity to further discuss
> and/or clarify your plan during such discussions and in your Final
> Proposal Revision (FPR). If, after discussions, the plan is still
> considered "unacceptable," your proposal may not be considered further
> for award.

b.  **Women and Minorities**

> Women and members of minority groups and their subpopulations must be
> included in the study population of research involving human subjects,
> unless a clear and compelling rationale and justification are provided
> indicating that inclusion is inappropriate with respect to the health
> of the subjects or the purpose of the research. In addition, for
> NIH-Defined Phase III clinical trials, all proposals and/or protocols
> must provide a description of plans to conduct analyses, as
> appropriate, to detect significant differences in intervention effect
> (see NIH Guide , Definitions - Significant Difference) by sex/gender,
> racial/ethnic groups, and relevant subpopulations, if applicable,
> unless the Government has specified that this solicitation involves a
> sex/gender specific study or a single or limited number of minority
> population groups. The proposal also must include one of the following
> plans:
>
> []{.mark}

-   Plans to conduct valid analysis to detect significant differences in
    intervention effect among sex/gender and/or racial/ethnic subgroups
    when prior studies strongly support these significant differences
    among subgroups, OR

-   Plans to include and analyze sex/gender and/or racial/ethnic
    subgroups when prior studies strongly support no significant
    differences in intervention effect between subgroups (representation
    of sex/gender and/or racial/ethnic groups as subject selection
    criterion is not required; however, inclusion and analyses are
    encouraged), OR

-   Plans to conduct valid analyses of the intervention effect in
    sex/gender and/or racial/ethnic subgroups (without requiring high
    statistical power for each subgroup) when the prior studies neither
    support nor negate significant differences in intervention effect
    between subgroups.

> []{.mark}
>
> Also, the proposal must address the proposed outreach programs for
> recruiting women and minorities as participants.
>
> Reviewers will address the areas covered here and in Section L of the
> solicitation in narrative form in their evaluation. Some of the issues
> they will evaluate include:
>
> []{.mark}

-   whether the plan proposed includes minorities and both genders in
    adequate representation

-   how the offeror addresses the inclusion of women and members of
    minority groups and their subpopulations in the development of a
    proposal that is appropriate to the scientific objectives of the
    solicitation

-   the description of the proposed study populations in terms of
    sex/gender and racial/ethnic groups and the rationale for selection
    of such subjects

-   if exclusion is proposed, that the rationale is appropriate with
    respect to the health of the subjects and/or to the purpose of the
    research.

-   In addition, for gender exclusion, the reviewers will examine the
    rationale to determine if it is because:

```{=html}
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```
-   the purpose of the research constrains the offeror's selection of
    study participants by gender (e.g., uniquely valuable stored
    specimens or existing datasets are single gender; very small numbers
    of subjects are involved; or

-   overriding factors dictate selection of subjects); or

-   gender representation of specimens or existing datasets cannot be
    accurately determined, [and]{.underline} this does not compromise
    the scientific objectives of the research.

```{=html}
<!-- -->
```
-   For minority group exclusion, the reviewers will examine the
    rationale to determine if those minority groups are excluded
    because:

```{=html}
<!-- -->
```
-   inclusion of those groups would be inappropriate with respect to
    their health,;or

-   inclusion of those groups would be inappropriate with respect to the
    purpose of the research.

```{=html}
<!-- -->
```
-   For NIH-defined Phase III clinical trials, reviewers will also
    address whether there is an adequate description of plans to conduct
    analyses to detect significant differences of clinical or public
    health importance in intervention effect(s) by sex/gender and/or
    racial ethnic subgroups when the intervention effect(s) is expected
    in the primary analyses, or if there is an adequate description of
    plans to conduct valid analyses of the intervention effect in
    subgroups when the intervention effect(s) is [not]{.underline}
    expected in the primary analyses.

> []{.mark}
>
> If you determine that inclusion of women and minority populations is
> not feasible, you must submit a detailed rationale and justification
> for exclusion of one or both groups from the study population with the
> technical proposal. The Government will review the rationale to
> determine if it is appropriate with respect to the health of the
> subjects and/or the purpose of the research
>
> Based on the evaluation of the response to this criterion, this
> section of the proposal may be rated "unacceptable" (i.e., no
> discussion can be found regarding the proposed gender/minority
> inclusion plans, or concerns are identified as to the gender or
> minority representation, or the proposal does not adequately address
> limited representation of one gender or minority; or the plan is not
> in accordance with NIH policy guidelines) or "acceptable." See Section
> L of the solicitation for the requirements of women/minorities
> inclusion.
>
> If the information you provide in your proposal regarding the
> inclusion of women and minorities is rated "unacceptable" and the
> Government includes your proposal in the competitive range (for
> competitive proposals), or if the Government holds discussions with
> the selected source (for sole source acquisitions), you will be
> afforded the opportunity to further discuss, clarify, or modify your
> plan during discussions and in your Final Proposal Revision (FPR). If
> your plan for inclusion/exclusion of women/minorities is still
> considered "unacceptable" by the Government after discussions, your
> proposal may not be considered further for award.

a.  **Children**

> Children (i.e. individuals under the age of 21) must be included in
> all human subject research unless there are clear and compelling
> reasons not to include them.
>
> Your proposal must include a description of plans for including
> children. If you plan to exclude children from the required research,
> your proposal must present an acceptable justification for the
> exclusion. If you determine that exclusion of a specific age range of
> child is appropriate, your proposal must also address the rationale
> for such exclusion. Also, the plan must include a description of the
> expertise of the investigative team for dealing with children at the
> ages included, of the appropriateness of the available facilities to
> accommodate the children, and the inclusion of a sufficient number of
> children to contribute to a meaningful analysis relative to the
> purpose/objective of the solicitation. Also, see Section L of the
> solicitation for further specific requirements on inclusion of
> children.
>
> Based on the reviewers' narrative evaluation of the offeror's response
> to this evaluation criterion, this section of the proposal may be
> rated "unacceptable" (i.e., no discussion can be found regarding the
> proposed inclusion plans for children; or concerns are identified as
> to the offeror's response regarding the inclusion of children; or the
> plan is not in accordance wit h NIH policy guidelines) or
> "acceptable."
>
> If the information provided in your proposal about the inclusion of
> children is rated "unacceptable" and the Government includes your
> proposal in the competitive range (for competitive proposals), or if
> the Government holds discussions with the selected source (for sole
> source acquisitions), you will be afforded the opportunity to further
> discuss, clarify or modify your plan during discussions and in your
> Final Proposal Revision (FPR). If your plan for inclusion of children
> is still considered "unacceptable" by the Government after
> discussions, your proposal may not be considered further for award.

**3. EVALUATION OF DATA SHARING PLAN**

> The offeror\'s plan for the sharing of final research data shall be
> assessed for appropriateness and adequacy.
>
> If your proposal does not include a plan or if the plan in your
> proposal is considered "unacceptable," and the Government includes
> your proposal in the competitive range (for competitive proposals), or
> if the Government holds discussions with the selected source (for sole
> source acquisitions), you will be afforded the opportunity to further
> discuss, clarify or modify your data sharing plan during discussions
> and in your Final Proposal Revision (FPR). If your data sharing plan
> is still considered "unacceptable" by the Government after
> discussions, your proposal may not be considered further for award.

**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 a product of
> a mechanical or mathematical analysis of an offeror\'s performance on
> a list of contracts but rather the product of subjective judgment by
> the Government after it considers relevant information.
>
> When assessing performance risks, the Government will focus on the
> past performance of the offeror as it relates to all acquisition
> requirements, such as the offeror\'s record of performing according to
> specifications, including standards of good workmanship; the
> offeror\'s record of controlling and forecasting costs; the offeror\'s
> adherence to contract schedules, including the administrative aspects
> of performance; the offeror\'s reputation for reasonable and
> cooperative behavior and commitment to customer satisfaction; and
> generally, the offeror\'s business-like concern for the interest of
> the customer.
>
> The Government will consider the currency and relevance of the
> information, source of the information, context of the data, and
> general trends in the offeror\'s performance.
>
> The lack of a relevant performance record may result in an unknown
> performance risk assessment, which will neither be used to the
> advantage nor disadvantage of the offeror.

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.

**6. TECHNICAL EVALUATION CRITERIA**

> The evaluation criteria are used by the technical evaluation committee
> when reviewing the technical proposals. The criteria below are listed
> in the order of relative importance with weights assigned for
> evaluation purposes.

**CRITERIA WEIGHT**

**A. TECHNICAL APPROACH 40 Points**

> 1\. Demonstrated understanding of the scope and objectives of the
> contract as evidenced by the soundness and practicality of the
> technical approach.
>
> Executing the requirements specified in the Statement of Work, with
> adequate explanation, substantiation and justification for the
> proposed methods for meeting the projected needs, including:

a.  statistical design and analysis, including the capacity to develop
    and apply innovative epidemiologic and statistical methods in
    longitudinal data analyses;

b.  establishing and administering reliable, efficient and responsive
    data management, validation, and quality assurance systems;

c.  designing and implementing clinical site training requirements and
    evaluations;

d.  supporting the development and writing of protocols for
    retrospective and prospective clinical studies;

e.  distribution and quality control of study instruments; and

f.  statistical, technical, administrative and logistical support for
    the activities of the TACC.

> **B. QUALIFICATIONS, EXPERIENCE AND AVAILABILITY OF PERSONNEL 30
> Points**
>
> 1\. Principal Investigator/Co-Investigators including:

a.  documented availability, training, qualifications, expertise,
    relevant experience, education, and leadership/management skills of
    the Principal Investigator and the co-investigators to successfully
    plan and manage the project;

b.  expertise in longitudinal cohort-specific study design;

c.  expertise in the implementation and monitoring of longitudinal data
    and clinical site training; and

d.  managerial ability to achieve delivery or performance requirements,
    drawing upon the resources of the primary contractor, and
    subcontractors/consultants as necessary.

> 2\. Other Personnel

a.  documented availability, training, qualifications, expertise,
    relevant experience, education and competence of the scientific,
    clinical, technical and administrative staff and any other proposed
    personnel \[including proposed subcontractors and consultants\], to
    perform the requirements of the Statement of Work; and

b.  expertise in the successful development and implementation of
    computerized databases and laboratory data management systems.

> **C. EXPERIENCE AND CAPABILITIES OF THE ORGANIZATION 20 Points**

1.  documented relevant experience of the organization in managing
    projects of similar complexity and scope and in managing multiple
    subcontracts and/or consultants;

2.  clarity and appropriateness of lines of communication and authority
    for coordination and management of the project;

3.  adequacy and feasibility of plans to ensure successful coordination
    of a multi-organizational collaboration; and

4.  ability to identify and procure ad-hoc clinical and scientific
    consultants to address the evolving science of HIV infection.

> **D. FACILITIES AND RESOURCES 10 Points**
>
> Documented availability and adequacy of facilities, equipment, space
> and resources, including shared resources and those of proposed
> subcontractor(s), necessary to carry out the Statement of Work,
> including:

1.  location and features of locked, fire-protected storage for hard
    copies of study files and documents;

2.  hardware and software specifications for proposed electronic data
    management and web-based systems;

3.  data storage and maintenance capabilities and establishment of
    security systems to insure confidentiality and protection of data;

4.  graphics capabilities; and

5.  telecommunications and conferencing capabilities.

> **TOTAL = 100 Points**

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

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

+-----------------------------------------------------------------------+
| **[THE BELOW TEMPLATE SHALL BE USED AS THE [TABLE OF                  |
| CONTENTS]{.underline} FOR YOUR TECHNICAL PROPOSAL, AND ALL            |
| INFORMATION IN YOUR TECHNICAL PROPOSAL SHOULD 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. 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}                                                             |
|                                                                       |
| **[OFFERORS ARE ADVISED TO GIVE CAREFUL CONSIDERATION TO THE          |
| STATEMENT OF WORK, ALL REFERENCE MATERIAL PROVIDED AS APPENDICES AND  |
| ATTACHMENTS, AND THE TECHNICAL EVALUATION CRITERIA IN THE DEVELOPMENT |
| OF YOUR PROPOSAL.]{.mark}**                                           |
+-----------------------------------------------------------------------+

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

***General Comment:*** Offerors may identify tasks, among those
described in this solicitation, for which they plan to utilize
subcontractors. This approach is encouraged if it allows the offeror to
more efficiently perform the numerous responsibilities of the DACC.
Offerors should describe the activities to be subcontracted, the method
and level of integration between the DACC and any proposed
subcontractor(s), and the expected advantages of such an approach.

The **[technical proposal may not exceed 150 pages]{.underline}** and
should provide specific information addressing the elements listed in
the Statement of Work and those specified below.

1.  **Collaboration with the TACC study sites and the TACC Coordinating
    Team (CT)**

> To address the requirement for a collaborative, accountable, and
> effective management structure, the Technical Proposal shall include:
>
> a\. An organizational chart demonstrating proposed lines of
> communication between DACC personnel, DAIDS staff, the CT, and
> Clinical Sites; and
>
> b\. A discussion of how the DACC will interact with DAIDS staff, the
> CT, TACC investigators, and study site personnel so that these parties
> may function as a team.

2.  **Initial Data Cleaning, Validation, and Quality Assurance Plan and
    Procedures**

> The Technical Proposal shall include an Initial Data Cleaning,
> Validation, and Quality Assurance plan and procedures for
> implementation, that shall discuss the requirements specified in the
> Statement of Work.

3.  **Ongoing Data Validation, Data Cleaning, and Quality Assurance**

> The Technical Proposal shall delineate strategies to establish and
> administer a data validation system for the collection, tracking,
> processing, integration, quality assurance, transfer and reporting of
> study data, as well as a system for electronic communication and
> collaboration. Data shall be located on a designated multiprocessor
> server with adequate memory and RAM to support complex data
> manipulation and graphical applications as well as working directories
> for data center staff and TACC investigators. The file system
> structure should provide an efficient means of organizing all
> components of the data center activities. Statistical software should
> include the most recent version of Windows for networking, SAS/BASE,
> SAS/STAT, SAS/GRAPH, SAS/IML, SAS/AF, SAS/FSP, SPlus, and other
> programming capacity for
>
> processing, storage, retrieval, and multivariable analyses of
> longitudinal clinical, laboratory, and pharmaceutical data for more
> than 5,000 observations. The offeror should provide an off-site
> facility for secure storage of system back-ups.
>
> The Technical Proposal should demonstrate the capacity of the offeror
> to address Data Management and Ongoing Quality Assurance needs as
> specified in the Statement of Work.

**4. Security Requirements**

> The Technical Proposal shall include plans to demonstrate compliance
> with security requirements as specified in the Statement of Work.

**5. Cohort Study Support, Training and Communication**

> The Technical Proposal shall include a feasible plan and demonstrate
> expertise to fulfill the activities listed in the Statement of Work
> for Cohort Study Support, Training, and Communication.

**6. Consultation in Scientific Design and Analytic Strategies**

> The Technical Proposal shall demonstrate that the broad range of
> expertise required can be adequately provided to address statistical
> approaches and clinical study design features that are important in
> developing and analyzing observational or interventional clinical
> studies.

**7. Data Analysis for Retrospective, Prospective, and Collaborative
Research**

> The Technical Proposal shall document staff expertise to conduct
> complex data analyses in support of manuscript preparation including:
>
> a\. Knowledge and analytic skills in theoretical statistics, data
> modeling, repeated measures, and exploratory data analysis using
> robust methods;
>
> b\. Descriptions of previous and current projects of a similar nature,
> including the grant or contract number, the sponsoring agency, the
> project officer, and description of the project; and
>
> c\. Reprints of all publications or reference list.

**8. Clinical Trial Design and Analytic Support**

> The Technical Proposal shall provide evidence of experience and
> capability to support the conduct of clinical trials and analyses of
> data derived therein as evidenced by work accomplished.

**9. Medical Reports and Presentations**

> Offerors shall include in their proposal examples of medical writing,
> identified by author and by other personnel.

**10.** **Final Transition of Data and Documentation**

> The Technical Proposal shall include a plan for an audit trail of all
> data corrections, editing, and analyses, and a final transfer of all
> TACC DACC data as specified in the Statement of Work.

11\. Personnel and Organization Management

> With regard to adequate qualified DACC personnel, the Technical
> Proposal shall include a Staffing Plan for the conduct of the
> Statement of Work, including role descriptions and level of effort of
> key scientific, technical and administrative personnel and, plans for
> back-up scientific, technical and administrative staffing.
>
> a\. Key Scientific and Technical Personnel: Describe the experience
> and qualifications, as well as the percentage of the total time each
> will be committed to the project. Identify the composition of the task
> or work group, its general qualifications and recent experience with
> similar efforts. As a minimum, this effort will require different
> staff/areas of expertise at different times over the course of the
> contract. Please provide documentation to describe:

-   Key Scientific and Technical Personnel (limit CVs to 2-3 pages)
    including doctoral level statistical analysts and epidemiologists,
    and one or more competent scientific writers, data programmers, and
    web developers;

-   Qualifications and relevant training as supported by academic
    degree(s) and demonstration of previous experience doing similar
    complex projects;

-   References to all publications;

-   Availability for the proposed project;

-   Summary of Related Activities.

> b\. Other Personnel: Offeror(s) should discuss the related experience
> and the role of other personnel as well as the ability to access and
> secure ad hoc clinical and scientific expertise as needed to address
> new scientific agendas in HIV infection. Other personnel may include
> non-key scientific, technical, and administrative personnel. *\[NOTE:
> Actual CVs for Other Personnel should not be included with the
> Technical Proposal but should be included with the Business Proposal.
> Although they will not be available for review by the initial peer
> review panel, they will be reviewed by the NIAID Project Officer and
> Contracting Officer as part of the analysis for competitive range
> determination.\]*

12\. Facilities and Resources

> The Technical Proposal shall document availability and adequacy of
> facilities, equipment, space and other resources necessary to carry
> out the Statement of Work, including:

a.  Location and features of secured storage for hard copies of
    documents and files;

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b.  Hardware and software for proposed electronic data management and
    web-based systems;

c.  Graphics capabilities; and

d.  Telecommunications and conferencing capabilities.

**13. Human Subjects / HIPPA**

> a\. Human Subjects
>
> Include plans for compliance with applicable domestic and
> international regulations on the use of human subjects (e.g. IRB
> submission and approval plans, consent procedures, etc.).
>
> b\. Health Insurance Portability and Accountability Act (HIPAA)
>
> Include plans for compliance with HIPAA.
>
> c\. Privacy Act
>
> Include plans for compliance with the Privacy Act.

**14. Past Performance Reference Material**

> The Technical Proposal should include documentation of past
> performance demonstrating scientific productivity and expertise as
> well as managerial ability, relevant experience, and capacity to
> achieve delivery and performance of requirements specified in the
> Statement of Work.

**15. Data Sharing Plan**

> The Technical Proposal should include a plan for preparing a public
> use data archive and a plan for preparing and transferring the
> DAIDS-ES-compatible required data.

**[APPENDIX B]{.underline}**

[]{#s .anchor}**ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS**

**UNIFORM BUDGET ASSUMPTIONS**

1.  **Collaboration with the TACC study sites and the TACC Coordinating
    Team (CT)**

> For cost estimating purposes, offerors shall assume the following:

-   The TACC DACC shall support travel of its scientific and project
    management staff to semi-annual meetings with the TACC CT and NIAID.
    One meeting per year will take place in the Washington, DC area. The
    second meeting each year will take place on a rotating basis between
    the TACC study sites and finalized by consensus by the TACC CT, TACC
    clinical site investigators, the TACC DACC, and the NIAID PO.
    Meetings will last 2-3 days. Study procedures will be evaluated,
    progress on the current scientific agenda will be presented and
    scientific questions to be addressed during the next six months will
    be jointly determined with the TACC DACC and the TACC site
    investigators.

-   Additional external advisory committee meetings will occur
    semi-annually and are usually scheduled to follow a large national
    scientific meeting. The TACC DACC will support travel of key
    personnel to the advisory committee meetings and other scientific
    meetings as deemed necessary by the TACC CT, the TACC DACC, and the
    NIAID PO.

**2. Initial Data Cleaning, Validation, and Quality Assurance**

> For cost estimating purposes, offerors are informed of the following:

-   There are seven TACC clinical sites throughout the U.S.

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-   Walter Reed Army Medical Center, Washington, D.C.

-   Tripler Army Medical Center, Honolulu, Hawaii

-   Brook Army Medical Center and Wilford Hall Medical Center, San
    Antonio, Texas

-   National Naval Medical Center, Bethesda, Maryland

-   U.S. Naval Medical Center, San Diego, California

-   Naval Medical Center, Portsmouth, Virginia.

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-   Approximately 4500 participants have been enrolled in the TACC
    cohort since 1986. At this time, 36% (n=1597) have unknown outcomes.

-   Approximately 125 new participants enroll in the TACC per year.

**3. Ongoing Data Validation, Data Cleaning, and Quality Assurance**

For cost estimating purposes, offerors are informed of the following:

-   HIV-1 Natural History data were derived from the consolidation of
    three protocols.

-   A new protocol is will be implemented in 2005.

-   The current data management system includes the following
    procedures:

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-   After each clinic visit, data are abstracted from medical records to
    complete TACC case report forms. These forms collect information on
    medical history and current diagnoses, medications, interim visits,
    hospitalizations, and laboratory results.

-   Case report forms are sent by courier or overnight carrier to the
    current data center.

-   Data are double entered into the database at the current data
    center.

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-   There is no system of quality assurance of the data.

-   Pharmacy data and laboratory results may be transferred
    electronically in the near future.

**4**. **Cohort Study Support, Training and Communication**

For cost estimating purposes, offerors shall assume the following:

-   Site visits for quality assurance evaluations will be conducted at
    each of the seven sites once per year.

-   Changes in study operating procedures or data entry shall require
    additional days of training at each site or at a central location by
    agreement.

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-   Interim site visits may occur more frequently as necessary.