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-DAIT-05-46

"Development of Improved DTPA for Radionuclide Chelation"

+----------------+-----+---+----+-----+-------+---+---+------------------------+
| 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. |     |   |    |     |       |   |   |                        |
| niaid.nih.gov/ |     |   |    |     |       |   |   |                        |
| contract/defau |     |   |    |     |       |   |   |                        |
| lt.htm**](http |     |   |    |     |       |   |   |                        |
| ://www.niaid.n |     |   |    |     |       |   |   |                        |
| ih.gov/contrac |     |   |    |     |       |   |   |                        |
| t/default.htm) |     |   |    |     |       |   |   |                        |
+----------------+-----+---+----+-----+-------+---+---+------------------------+
| 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 |   |                        |
| Date:          | Due |   |    |     |       | \ |   |                        |
|                | Da  |   |    |     |       | . |   |                        |
| April 26, 2005 | te: |   |    |     |       | S |   |                        |
|                | J   |   |    |     |       | m |   |                        |
|                | une |   |    |     |       | a |   |                        |
|                | 8,  |   |    |     |       | l |   |                        |
|                | 2   |   |    |     |       | l |   |                        |
|                | 005 |   |    |     |       | B |   |                        |
|                |     |   |    |     |       | u |   |                        |
|                | **T |   |    |     |       | s |   |                        |
|                | ime |   |    |     |       | . |   |                        |
|                | :** |   |    |     |       | S |   |                        |
|                | 3   |   |    |     |       | e |   |                        |
|                | :00 |   |    |     |       | t |   |                        |
|                | PM, |   |    |     |       | - |   |                        |
|                | Lo  |   |    |     |       | A |   |                        |
|                | cal |   |    |     |       | s |   |                        |
|                | T   |   |    |     |       | i |   |                        |
|                | ime |   |    |     |       | d |   |                        |
|                |     |   |    |     |       | e |   |                        |
|                |     |   |    |     |       | : |   |                        |
|                |     |   |    |     |       | \ |   |                        |
|                |     |   |    |     |       | [ |   |                        |
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|                |     |   |    |     |       | a |   |                        |
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|                |     |   |    |     |       | t |   |                        |
|                |     |   |    |     |       | I |   |                        |
|                |     |   |    |     |       | V |   |                        |
|                |     |   |    |     |       | , |   |                        |
|                |     |   |    |     |       | S |   |                        |
|                |     |   |    |     |       | e |   |                        |
|                |     |   |    |     |       | c |   |                        |
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|                |     |   |    |     |       | . |   |                        |
|                |     |   |    |     |       | ) |   |                        |
+----------------+-----+---+----+-----+-------+---+---+------------------------+
|                |     |   |    |     |       |   |   |                        |
+----------------+-----+---+----+-----+-------+---+---+------------------------+
| 6\. Just In    |     | 7 |    |     |       |   | 8 |                        |
| Time:          |     | \ |    |     |       |   | \ |                        |
|                |     | . |    |     |       |   | . |                        |
| \[X\] No       |     | N |    |     |       |   | [ |                        |
|                |     | u |    |     |       |   | * |                        |
| \[ \] Yes (See |     | m |    |     |       |   | * |                        |
| Part IV,       |     | b |    |     |       |   | T |                        |
| Section L.)    |     | e |    |     |       |   | e |                        |
|                |     | r |    |     |       |   | c |                        |
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|                |     | f |    |     |       |   | n |                        |
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|                |     |   |    |     |       |   | : |                        |
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|                |     |   |    |     |       |   | " |                        |
|                |     |   |    |     |       |   | P |                        |
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|                |     |   |    |     |       |   | c |                        |
|                |     |   |    |     |       |   | t |                        |
|                |     |   |    |     |       |   | r |                        |
|                |     |   |    |     |       |   | o |                        |
|                |     |   |    |     |       |   | n |                        |
|                |     |   |    |     |       |   | i |                        |
|                |     |   |    |     |       |   | c |                        |
|                |     |   |    |     |       |   | F |                        |
|                |     |   |    |     |       |   | i |                        |
|                |     |   |    |     |       |   | l |                        |
|                |     |   |    |     |       |   | e |                        |
|                |     |   |    |     |       |   | S |                        |
|                |     |   |    |     |       |   | i |                        |
|                |     |   |    |     |       |   | z |                        |
|                |     |   |    |     |       |   | e |                        |
|                |     |   |    |     |       |   | " |                        |
+----------------+-----+---+----+-----+-------+---+---+------------------------+
|                |     |   |    |     |       |   |   |                        |
+----------------+-----+---+----+-----+-------+---+---+------------------------+
| 9\. Issued By: |     |   |    | 1   |       |   |   |                        |
|                |     |   |    | 0\. |       |   |   |                        |
| Olga           |     |   |    | \[  |       |   |   |                        |
| Acosta-Polston |     |   |    | X\] |       |   |   |                        |
|                |     |   |    | We  |       |   |   |                        |
| Senior         |     |   |    | r   |       |   |   |                        |
| Contracting    |     |   |    | ese |       |   |   |                        |
| Officer        |     |   |    | rve |       |   |   |                        |
|                |     |   |    | the |       |   |   |                        |
| Contract       |     |   |    | ri  |       |   |   |                        |
| Management     |     |   |    | ght |       |   |   |                        |
| Program, DEA   |     |   |    | to  |       |   |   |                        |
|                |     |   |    | m   |       |   |   |                        |
| NIH, NIAID     |     |   |    | ake |       |   |   |                        |
|                |     |   |    | awa |       |   |   |                        |
| 6700-B         |     |   |    | rds |       |   |   |                        |
| Rockledge      |     |   |    | w   |       |   |   |                        |
| Drive          |     |   |    | ith |       |   |   |                        |
|                |     |   |    | out |       |   |   |                        |
| Room 3100, MSC |     |   |    | di  |       |   |   |                        |
| 7612           |     |   |    | scu |       |   |   |                        |
|                |     |   |    | ssi |       |   |   |                        |
| Bethesda, MD   |     |   |    | on. |       |   |   |                        |
| 20892-7612     |     |   |    |     |       |   |   |                        |
+----------------+-----+---+----+-----+-------+---+---+------------------------+
|                |     |   |    | #   |       |   |   | 12\. Period of         |
|                |     |   |    | # 1 |       |   |   | Performance:           |
|                |     |   |    | 1.  |       |   |   |                        |
|                |     |   |    | Opt |       |   |   | 21 months beginning on |
|                |     |   |    | ion |       |   |   | or about September 30, |
|                |     |   |    | s:  |       |   |   | 2005                   |
|                |     |   |    |     |       |   |   |                        |
|                |     |   |    | ##  |       |   |   | ##                     |
|                |     |   |    |     |       |   |   |                        |
|                |     |   |    | ##  |       |   |   |                        |
|                |     |   |    |  \[ |       |   |   |                        |
|                |     |   |    |  \] |       |   |   |                        |
|                |     |   |    |  No |       |   |   |                        |
|                |     |   |    |     |       |   |   |                        |
|                |     |   |    | *   |       |   |   |                        |
|                |     |   |    | *\[ |       |   |   |                        |
|                |     |   |    | X\] |       |   |   |                        |
|                |     |   |    | Yes |       |   |   |                        |
|                |     |   |    | (   |       |   |   |                        |
|                |     |   |    | See |       |   |   |                        |
|                |     |   |    | P   |       |   |   |                        |
|                |     |   |    | art |       |   |   |                        |
|                |     |   |    | IV, |       |   |   |                        |
|                |     |   |    | S   |       |   |   |                        |
|                |     |   |    | ect |       |   |   |                        |
|                |     |   |    | ion |       |   |   |                        |
|                |     |   |    | L.  |       |   |   |                        |
|                |     |   |    | )** |       |   |   |                        |
+----------------+-----+---+----+-----+-------+---+---+------------------------+
| 13\. Primary   |     |   | 14 |     |       |   |   | 15\. Protest Officer:  |
| Point of       |     |   | \. |     |       |   |   |                        |
| Contact:       |     |   | S  |     |       |   |   | Director, CMP          |
|                |     |   | ec |     |       |   |   |                        |
| Name : Donald  |     |   | on |     |       |   |   | Address (see Block 9.) |
| E. Collie      |     |   | da |     |       |   |   |                        |
|                |     |   | ry |     |       |   |   |                        |
| Phone:         |     |   | P  |     |       |   |   |                        |
| 301-496-0992   |     |   | oi |     |       |   |   |                        |
|                |     |   | nt |     |       |   |   |                        |
| Fax:           |     |   | of |     |       |   |   |                        |
| 301-480-4675   |     |   | Co |     |       |   |   |                        |
|                |     |   | nt |     |       |   |   |                        |
| E-Mail:        |     |   | ac |     |       |   |   |                        |
| <d             |     |   | t: |     |       |   |   |                        |
| c128b@nih.gov> |     |   |    |     |       |   |   |                        |
|                |     |   | N  |     |       |   |   |                        |
|                |     |   | am |     |       |   |   |                        |
|                |     |   | e: |     |       |   |   |                        |
|                |     |   | Ol |     |       |   |   |                        |
|                |     |   | ga |     |       |   |   |                        |
|                |     |   | Ac |     |       |   |   |                        |
|                |     |   | os |     |       |   |   |                        |
|                |     |   | ta |     |       |   |   |                        |
|                |     |   | -P |     |       |   |   |                        |
|                |     |   | ol |     |       |   |   |                        |
|                |     |   | st |     |       |   |   |                        |
|                |     |   | on |     |       |   |   |                        |
|                |     |   |    |     |       |   |   |                        |
|                |     |   | Ph |     |       |   |   |                        |
|                |     |   | on |     |       |   |   |                        |
|                |     |   | e: |     |       |   |   |                        |
|                |     |   | 30 |     |       |   |   |                        |
|                |     |   | 1- |     |       |   |   |                        |
|                |     |   | 43 |     |       |   |   |                        |
|                |     |   | 5- |     |       |   |   |                        |
|                |     |   | 43 |     |       |   |   |                        |
|                |     |   | 22 |     |       |   |   |                        |
|                |     |   |    |     |       |   |   |                        |
|                |     |   | Fa |     |       |   |   |                        |
|                |     |   | x: |     |       |   |   |                        |
|                |     |   | 30 |     |       |   |   |                        |
|                |     |   | 1- |     |       |   |   |                        |
|                |     |   | 48 |     |       |   |   |                        |
|                |     |   | 0- |     |       |   |   |                        |
|                |     |   | 46 |     |       |   |   |                        |
|                |     |   | 75 |     |       |   |   |                        |
|                |     |   |    |     |       |   |   |                        |
|                |     |   | E  |     |       |   |   |                        |
|                |     |   | -M |     |       |   |   |                        |
|                |     |   | ai |     |       |   |   |                        |
|                |     |   | l: |     |       |   |   |                        |
|                |     |   | <  |     |       |   |   |                        |
|                |     |   | od |     |       |   |   |                        |
|                |     |   | 3m |     |       |   |   |                        |
|                |     |   | @. |     |       |   |   |                        |
|                |     |   | ni |     |       |   |   |                        |
|                |     |   | h. |     |       |   |   |                        |
|                |     |   | go |     |       |   |   |                        |
|                |     |   | v> |     |       |   |   |                        |
+----------------+-----+---+----+-----+-------+---+---+------------------------+
| 16. **COLLECT  |     |   |    |     |       |   |   |                        |
|     CALLS WILL |     |   |    |     |       |   |   |                        |
|     NOT BE     |     |   |    |     |       |   |   |                        |
|     ACCEPTED.  |     |   |    |     |       |   |   |                        |
|     FACSIMILE  |     |   |    |     |       |   |   |                        |
|                |     |   |    |     |       |   |   |                        |
|    SUBMISSIONS |     |   |    |     |       |   |   |                        |
|     ARE NOT    |     |   |    |     |       |   |   |                        |
|                |     |   |    |     |       |   |   |                        |
|  ACCEPTABLE.** |     |   |    |     |       |   |   |                        |
+----------------+-----+---+----+-----+-------+---+---+------------------------+
| 17. Offers     |     |   |    |     |       |   |   |                        |
|     will be    |     |   |    |     |       |   |   |                        |
|     valid for  |     |   |    |     |       |   |   |                        |
|     120 days   |     |   |    |     |       |   |   |                        |
|     unless a   |     |   |    |     |       |   |   |                        |
|     different  |     |   |    |     |       |   |   |                        |
|     period is  |     |   |    |     |       |   |   |                        |
|     specified  |     |   |    |     |       |   |   |                        |
|     by the     |     |   |    |     |       |   |   |                        |
|     Offeror on |     |   |    |     |       |   |   |                        |
|     the form   |     |   |    |     |       |   |   |                        |
|     entitled   |     |   |    |     |       |   |   |                        |
|     "Proposal  |     |   |    |     |       |   |   |                        |
|     Summary    |     |   |    |     |       |   |   |                        |
|     and Data   |     |   |    |     |       |   |   |                        |
|     Record,    |     |   |    |     |       |   |   |                        |
|     NIH-2043\" |     |   |    |     |       |   |   |                        |
|     (See       |     |   |    |     |       |   |   |                        |
|     SECTION J  |     |   |    |     |       |   |   |                        |
|     --         |     |   |    |     |       |   |   |                        |
|                |     |   |    |     |       |   |   |                        |
|   Attachments) |     |   |    |     |       |   |   |                        |
+----------------+-----+---+----+-----+-------+---+---+------------------------+
|                |     |   |    |     |       |   |   |                        |
+----------------+-----+---+----+-----+-------+---+---+------------------------+
| 18\. DELIVERY  |     |   |    |     |       |   |   |                        |
| ADDRESS        |     |   |    |     |       |   |   |                        |
| INFORMATION    |     |   |    |     |       |   |   |                        |
+----------------+-----+---+----+-----+-------+---+---+------------------------+
| Hand Delivery  |     |   |    |     | ###   |   |   |                        |
| or Overnight   |     |   |    |     | U.S.  |   |   |                        |
| Service:       |     |   |    |     | Posta |   |   |                        |
|                |     |   |    |     | l Ser |   |   |                        |
| Donald E.      |     |   |    |     | vice  |   |   |                        |
| Collie         |     |   |    |     | or an |   |   |                        |
|                |     |   |    |     |  Expr |   |   |                        |
| Contract       |     |   |    |     | ess D |   |   |                        |
| Management     |     |   |    |     | elive |   |   |                        |
| Program, DEA,  |     |   |    |     | ry Se |   |   |                        |
| NIAID, NIH     |     |   |    |     | rvice |   |   |                        |
|                |     |   |    |     |       |   |   |                        |
| 6700-B         |     |   |    |     | D     |   |   |                        |
| Rockledge      |     |   |    |     | onald |   |   |                        |
| Drive, Room    |     |   |    |     | E.    |   |   |                        |
| 3214           |     |   |    |     | C     |   |   |                        |
|                |     |   |    |     | ollie |   |   |                        |
| Bethesda, MD   |     |   |    |     |       |   |   |                        |
| 20817          |     |   |    |     | Con   |   |   |                        |
|                |     |   |    |     | tract |   |   |                        |
|                |     |   |    |     | Manag |   |   |                        |
|                |     |   |    |     | ement |   |   |                        |
|                |     |   |    |     | Pro   |   |   |                        |
|                |     |   |    |     | gram, |   |   |                        |
|                |     |   |    |     | DEA,  |   |   |                        |
|                |     |   |    |     | N     |   |   |                        |
|                |     |   |    |     | IAID, |   |   |                        |
|                |     |   |    |     | NIH   |   |   |                        |
|                |     |   |    |     |       |   |   |                        |
|                |     |   |    |     | 6     |   |   |                        |
|                |     |   |    |     | 700-B |   |   |                        |
|                |     |   |    |     | Rock  |   |   |                        |
|                |     |   |    |     | ledge |   |   |                        |
|                |     |   |    |     | D     |   |   |                        |
|                |     |   |    |     | rive, |   |   |                        |
|                |     |   |    |     | Room  |   |   |                        |
|                |     |   |    |     | 3214, |   |   |                        |
|                |     |   |    |     | MSC   |   |   |                        |
|                |     |   |    |     | 7612  |   |   |                        |
|                |     |   |    |     |       |   |   |                        |
|                |     |   |    |     | Beth  |   |   |                        |
|                |     |   |    |     | esda, |   |   |                        |
|                |     |   |    |     | MD    |   |   |                        |
|                |     |   |    |     | 20892 |   |   |                        |
|                |     |   |    |     | -7612 |   |   |                        |
+----------------+-----+---+----+-----+-------+---+---+------------------------+
| **19**.The     |     |   |    |     |       |   |   |                        |
| [Official      |     |   |    |     |       |   |   |                        |
| Point of       |     |   |    |     |       |   |   |                        |
| Receip         |     |   |    |     |       |   |   |                        |
| t]{.underline} |     |   |    |     |       |   |   |                        |
| for the        |     |   |    |     |       |   |   |                        |
| purpose of     |     |   |    |     |       |   |   |                        |
| determining    |     |   |    |     |       |   |   |                        |
| timely         |     |   |    |     |       |   |   |                        |
| delivery is    |     |   |    |     |       |   |   |                        |
| the address    |     |   |    |     |       |   |   |                        |
| provided in    |     |   |    |     |       |   |   |                        |
| Block 18,      |     |   |    |     |       |   |   |                        |
| above. The     |     |   |    |     |       |   |   |                        |
| paper copy     |     |   |    |     |       |   |   |                        |
| with original  |     |   |    |     |       |   |   |                        |
| signatures is  |     |   |    |     |       |   |   |                        |
| the official   |     |   |    |     |       |   |   |                        |
| copy for       |     |   |    |     |       |   |   |                        |
| recording      |     |   |    |     |       |   |   |                        |
| timely         |     |   |    |     |       |   |   |                        |
| receipt. If    |     |   |    |     |       |   |   |                        |
| the paper copy |     |   |    |     |       |   |   |                        |
| of your        |     |   |    |     |       |   |   |                        |
| proposal is    |     |   |    |     |       |   |   |                        |
| not received   |     |   |    |     |       |   |   |                        |
| by the         |     |   |    |     |       |   |   |                        |
| Contracting    |     |   |    |     |       |   |   |                        |
| Officer or     |     |   |    |     |       |   |   |                        |
| Designee at    |     |   |    |     |       |   |   |                        |
| the place and  |     |   |    |     |       |   |   |                        |
| time           |     |   |    |     |       |   |   |                        |
| specified,     |     |   |    |     |       |   |   |                        |
| then it will   |     |   |    |     |       |   |   |                        |
| be considered  |     |   |    |     |       |   |   |                        |
| late and       |     |   |    |     |       |   |   |                        |
| handled in     |     |   |    |     |       |   |   |                        |
| accordance     |     |   |    |     |       |   |   |                        |
| with HHSAR     |     |   |    |     |       |   |   |                        |
| 352.215-70     |     |   |    |     |       |   |   |                        |
| entitled       |     |   |    |     |       |   |   |                        |
| \"Late         |     |   |    |     |       |   |   |                        |
| Proposals and  |     |   |    |     |       |   |   |                        |
| Revisions\"    |     |   |    |     |       |   |   |                        |
| located in     |     |   |    |     |       |   |   |                        |
| this           |     |   |    |     |       |   |   |                        |
| Solicitation.  |     |   |    |     |       |   |   |                        |
| FACSIMILE      |     |   |    |     |       |   |   |                        |
| SUBMISSION OF  |     |   |    |     |       |   |   |                        |
| PROPOSALS IS   |     |   |    |     |       |   |   |                        |
| NOT            |     |   |    |     |       |   |   |                        |
| ACCEPTABLE.    |     |   |    |     |       |   |   |                        |
+----------------+-----+---+----+-----+-------+---+---+------------------------+

**TABLE OF CONTENTS**

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

[**BACKGROUND**](#B)

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

[**SECTIONS B -- H** \-- **UNIFORM CONTRACT FORMAT --
GENERAL**](#part-i---the-schedule)

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

### ARTICLE I.1. General Clauses

### [ARTICLE I.2. Authorized Substitutions Of Clauses](#section-l---instructions-conditions-and-notices-to-offerors)

### [ARTICLE I.3. Additional Contract Clauses](#section-m---evaluation-factors-for-award)

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

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

[**\[includes proposal submission instructions, page limitations and
electronic file size limitations\]**](#F)

[**SECTION K \-- REPRESENTATIONS AND CERTIFICATIONS AND OTHER
STATEMENTS**](#G)

> **[[OF OFFERORS OR QUOTERS]{.underline}](#G) (NEGOTIATED)**

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

1\. [**General Information**](#O)

2\. [**Instructions to Offerors**](#P)

a\. [**General Instructions**](#P)

b\. [**Technical Proposal Instructions**](#Q)

c\. [**Business Proposal Instructions**](#R)

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

[]{#B .anchor}BACKGROUND

The potential for radiation exposures to occur from terrorist acts,
radiation accidents or nuclear detonation mandates that the health care
system develop and implement preparedness plans that include the
stockpiling of radioprotective drugs and therapeutics. Radiation
exposure can occur from external irradiation, external contamination
with radioactive materials, and internal contamination by inhalation,
ingestion or absorption through skin or wounds. The removal of certain
internal radioactive contaminants can be accomplished by administering
chelating agents that can preferentially complex with radionuclides in
the body and increase their rate of clearance, thereby decreasing
radiation exposure.

Pentetate (diethylenetriaminepentaacetate) calcium trisodium (Ca-DTPA)
and pentetate (diethylenetriaminepentaacetate) zinc trisodium (Zn-DTPA)
have been shown to be effective in treating internal contamination with
radionuclides such as plutonium, americium, or curium. DTPA increases
the rates of elimination of these substances from the body through the
exchange of calcium or zinc ions with the transuranium element. The
transuranium-DTPA complex is stable and is excreted in urine. The
calcium salt is 10X more effective than the zinc salt of DTPA in the
first 24 hours following internal contamination, but after 24 hours, the
salts are similarly effective.

DTPA has been available for distribution from the Radiation Emergency
Assistance Center/Training Site under an IND and formulations of Ca-DTPA
and Zn-DTPA suitable for intravenous administration, or inhalation via
nebulizer, were approved by the FDA in August 2004. Other formulations
(for example oral, inhalation or transdermal) would be more easily
administered than the injectable formulations, making DTPA easier to use
in a mass casualty situation; however, because of its hydrophilicity,
DTPA is poorly absorbed when administered by these routes. The NIAID is
interested in facilitating the discovery and demonstration of
proof-of-concept of prodrugs, alternative formulations, or alternative
delivery methods of DTPA that provide for plasma levels sufficient to
decorporate systemic transuranic compounds for use by the general public
in the case of a radiation emergency. In addition, the NIAID is
interested in facilitating the development of prodrugs, alternative
formulations, or alternative delivery methods that provide for lung
clearance of transuranic compounds and that can be used in a mass
casualty situation. The ultimate goal of the DTPA development effort is
to identify effective candidates that could be evaluated for inclusion
in the Strategic National Stockpile.

The NIAID anticipates awarding up to three (3) contracts to separate
offerors based on technical merit, available funds, scientific priority,
and programmatic balance. The NIAID estimates that the average total
cost (direct and indirect cost combined) for these contracts will be
greater than \$1 million per contract; however, it is anticipated that
the total cost for each award may vary depending upon the scope of the
project and the technical objectives of the award. The length of time
for which funding is requested should be consistent with the nature and
complexity of the proposed research. The period of performance is
expected to be a total of twenty-one (21) months. The anticipated base
contract period (Phase 1) will be fourteen (14) months with Option 1
(Phase 2), if exercised, being seven (7) months.

[]{#C .anchor}**Statement of Work**

**Development of Improved DTPA for Radionuclide Chelation**

**RFP NIH-NIAID-DAIT-05-46**

Independently and not as an agent of the Government, the Offeror shall
furnish the necessary service, qualified personnel, material, equipment
and facilities not otherwise provided by the Government as needed to
perform the work described below. The Offeror is expected to develop and
execute a plan for the development of an alternative structure
(specifically a prodrug which can be metabolized to yield DTPA),
formulation or delivery method of DTPA that does not require intravenous
injection in order to achieve sufficient levels in plasma and sufficient
decorporation of systemic transuranic compounds, or improved clearance
of transuranic compounds or ease of use in the case of inhaled
transuranic compounds.

This contract will provide for initial discovery of lead compound(s) or
formulations to the proof-of-concept stage (demonstration of adequate
pharmacokinetics and effective elimination of transuranic compounds) and
will be funded in two phases; therefore, funding for Phase 2 is
contingent upon acceptance of progress by the NIAID Project Officer and
program staff in consultation with the Offeror. Phase 1 will include the
planning, synthesis, assay development and screening of drug candidates
or formulations. Phase 2, which will be funded after successful
completion of Phase 1 and selection of lead candidates in consultation
with and after approval of the NIAID Project Officer, will include the
evaluation of pharmacokinetics and decorporation efficacy of lead
candidates. The results will be evaluated to select the best candidates
for further testing and development under a separate contract. The
ultimate goal of the DTPA development effort is to identify effective
candidates that could be evaluated for inclusion in the Strategic
National Stockpile.

Specifically, the Offeror will:

> Phase 1:
>
> 1\. Design a strategy and technical approach to develop effective DTPA
> prodrugs, formulations or delivery methods that allow for the rapid
> absorption and bioavailability of DTPA at rates and quantities
> equivalent to intravenous administration or improved ease-of-use in
> the case of lung clearance of inhaled radionuclides. The strategic
> plan should include how cGMP manufacture would be accomplished. The
> Offeror should be aware of the patent licensing and exclusion issues
> regarding their product innovation(s) and describe the steps that the
> Offeror has taken to ensure that the resulting product may be
> developed for use as nuclear contamination countermeasures.
>
> 2\. Synthesize and formulate quantities of DTPA drug candidates for
> evaluation of physiochemical properties, in vitro and/or in vivo
> absorption kinetics, bioavailability in vivo and radionuclide
> chelation efficiency.
>
> 3\. Develop and conduct a screening strategy to select appropriate
> DTPA prodrugs and formulations for further testing (such as partition
> coefficients, in vitro absorption models, in vivo absorption models,
> in vitro chelation models).
>
> 4\. Develop analytical methods for the detection and measurement of
> DTPA both in product formulations and in biological fluids. If DTPA
> has been covalently modified to form a prodrug, a method for the
> discrimination of native and modified DTPA shall be included.
>
> 5\. Provide a Phase 1 Milestone Report including strategy and
> technical approach for Phase 2.
>
> Phase 2 (Option -- Funding contingent upon acceptance of Phase 1 DTPA
> prodrugs, formulations or delivery method.):
>
> 1\. Conduct in vivo studies in rodents to compare absorption kinetics,
> bioavailability and decorporation efficacy of DTPA administered
> intravenously and selected lead candidate(s) of modified DTPA
> administered by appropriate route (such as oral, inhalation or
> transdermal). These studies will include general observations to
> assess toxicity of the formulation and an estimate of the Maximum
> Tolerated Dose. Offeror must have or have access to facilities
> licensed to perform in vivo chelation experiments using appropriate
> transuranic elements or their equivalents.
>
> 2\. Provide Phase 2 and Final Reports.

References:

<http://www.fda.gov/cder/guidance/6455fnl.htm> - Guidance for Industry,
Calcium DTPA and Zinc DTPA Drug Products --- Submitting a New Drug
Application.

<http://www.fda.gov/cder/guidance/6394dft.htm> - Guidance for Industry,
Internal Radioactive Contamination --- Development of Decorporation
Agents.

<http://www.fda.gov/cder/foi/label/2004/021749lbl.pdf> - Ca-DTPA Package
Insert.

<http://www.fda.gov/cder/foi/label/2004/021751lbl.pdf> - Zn-DTPA Package
Insert.

## Report and Deliverables 

The Offeror shall provide the following information to the NIAID Program
Officer and Contracting Officer:

1\) **Quarterly Progress Report:** Every 90 days the Offeror shall
submit a Quarterly Technical Progress Report. A Quarterly Progress
Report will not be required for the periods when the Milestone or Final
Reports are due. Copies of submitted and accepted papers and abstracts
shall be submitted. Such reports shall include the following specific
information:

> a\. Cover Page: List the contract number and title, the period of
> performance being reported, the Offeror\'s names and address, the
> author(s), and the date of submission.
>
> b\. SECTION I (Introduction): Describe the purpose and scope of the
> contract effort for the period covered.
>
> c\. SECTION II (Results): Detail, document, and summarize the results
> of each ongoing and completed protocol done during the period covered.
> These reports shall be in sufficient detail to explain the results
> achieved. The description shall include pertinent data and/or graphs
> in sufficient detail to explain any significant results achieved and
> preliminary conclusions resulting from analysis and scientific
> evaluation of data accumulated to date under the project.
>
> d\. SECTION III (Substantive Performance): Describe the current
> technical or substantive performance and any problems encountered
> and/or which may exist along with proposed corrective action. Also to
> be included is an explanation of any difference between planned
> progress and actual progress, why the differences have occurred, and
> if behind planned progress, what corrective steps are planned.
>
> e SECTION IV (Experimental Plan) List and provide a brief description
> of work proposed for the next quarter.

2\) **Phase 1** **Milestone Report:** When the work in Phase 1 has been
completed, the Offeror shall submit a comprehensive Milestone Report.
The Milestone Report shall detail, document and summarize the results of
the first phase of work performed to fulfill the requirements as
specified in the Statement of Work and shall be comprised of a cover
page and Sections I and II as specified for the Quarterly Progress
Report, above. A strategic plan for the work proposed in Phase 2 will
also be included in the Milestone Report. The strategic plan will
consist of the submitted Phase 2 proposal updated to include specific
plans based on results from the Phase 1 studies. Copies of submitted and
accepted papers and abstracts shall be submitted. The Offeror will also
prepare and present in person results and plans to the NIAID Project
Officer, and other individuals involved in the Radiation/Nuclear Program
prior to consideration for Phase 2 funding. A decision regarding funding
for Phase 2 will be made within 30 days of the presentation of Phase 1
data.

3\) **Phase 2 (if funded) and Final Report:** By the expiration date of
the contract, the Offeror shall submit a comprehensive Phase 2 and Final
Report. This Report shall detail, document and summarize the results of
the second phase of the contract and the entire contract work for the
period covered, and shall be comprised of a cover page and Sections I
and II as specified for the Quarterly Progress Report, above. Copies of
submitted and accepted papers and abstracts shall be submitted. Full
reporting of inventions (including name(s) of inventor(s), title(s) of
invention(s) and date each invention was reported to NIH) first
conceived or actually reduced to practice, as well as any copyrights
produced, under the contract will also be included in the Phase 2 and
Final Report. The Offeror will also prepare and present results and
plans in person to the NIAID program officials.

**Period of Performance and Budget**

The NIAID anticipates awarding up to three (3) contracts based on
technical merit, available funds, scientific priority, and programmatic
balance. The NIAID estimates that the average total cost (direct and
indirect cost combined) for these contracts will be greater than \$1
million per contract; however, it is anticipated that the total cost for
each award may vary depending upon the scope of the project and the
technical objectives of the award. The length of time for which funding
is requested should be consistent with the nature and complexity of the
proposed research. The period of performance is expected to be a total
of twenty-one (21) months. The anticipated base contract period
(Phase 1) will be fourteen (14) months with Option 1 (Phase 2), if
exercised, being seven (7) months.

\[END OF STATEMENT OF WORK\]

# 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 FOR A NEGOTIATED FIXED-PRICE RESEARCH AND
DEVELOPMENT CONTRACT - FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE
(FEBRUARY 1998)**

This RFP incorporates the following clauses by reference with the same
force and effect as if they were given full text. Upon request, the
Contracting Officer will make their full text available. Also, the full
text of a clause may be accessed electronically at this address:
http://www.arnet.gov/far/.

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

  ----------------------- -------------------- --------------------------
  FAR CLAUSE NO.          DATE                 TITLE

  ----------------------- -------------------- --------------------------

  ----------- ---------- --------------------------------------------------
  52.202-1    Jul 2004   Definitions

  52.203-3    Apr 1984   Gratuities (Over \$100,000)

  52.203-5    Apr 1984   Covenant Against Contingent Fees (Over \$100,000)

  52.203-6    Jul 1995   Restrictions on Subcontractor Sales to the
                         Government (Over \$100,000)

  52.203-7    Jul 1995   Anti-Kickback Procedures (Over \$100,000)

  52.203-8    Jan 1997   Cancellation, Rescission, and Recovery of Funds
                         for Illegal or Improper Activity (Over \$100,000)

  52.203-10   Jan 1997   Price or Fee Adjustment for Illegal or Improper
                         Activity (Over \$100,000)

  52.203-12   Jun 2003   Limitation on Payments to Influence Certain
                         Federal Transactions (Over \$100,000)

  52.204-4    Aug 2000   Printed or Copied Double-Sided on Recycled Paper
                         (Over \$100,000)

  52.204-7    Oct 2003   Central Contractor Registration

  52.209-6    Jul 1995   Protecting the Government\'s Interests When
                         Subcontracting With Contractors Debarred,
                         Suspended, or Proposed for Debarment (Over
                         \$25,000)

  52.215-2    Jun 1999   Audit and Records - Negotiation (Over \$100,000)

  52.215-8    Oct 1997   Order of Precedence - Uniform Contract Format

  52.215-10   Oct 1997   Price Reduction for Defective Cost or Pricing Data

  52.215-12   Oct 1997   Subcontractor Cost or Pricing Data (Over
                         \$500,000)

  52.215-14   Oct 1997   Integrity of Unit Prices (Over \$100,000)

  52.215-15   Jan 2004   Pension Adjustments and Asset Reversions

  52.215-18   Oct 1997   Reversion or Adjustment of Plans for
                         Post-Retirement Benefits (PRB) other than Pensions

  52.215-19   Oct 1997   Notification of Ownership Changes

  52.215-21   Oct 1997   Requirements for Cost or Pricing Data or
                         Information Other Than Cost or Pricing Data -
                         Modifications

  52.219-8    May 2004   Utilization of Small Business Concerns (Over
                         \$100,000)

  52.219-9    Jan 2002   Small Business Subcontracting Plan (Over
                         \$500,000)

  52.219-16   Jan 1999   Liquidated Damages - Subcontracting Plan (Over
                         \$500,000)

  52.222-3    Jun 2003   Convict Labor

  52.222-26   Apr 2002   Equal Opportunity

  52.222-35   Dec 2001   Equal Opportunity for Special Disabled Veterans,
                         Veterans of the Vietnam Era, and Other Eligible
                         Veterans

  52.222-36   Jun 1998   Affirmative Action for Workers with Disabilities

  52.222-37   Dec 2001   Employment Reports on Special Disabled Veterans,
                         Veterans of the Vietnam Era, and Other Eligible
                         Veterans

  52.223-6    May 2001   Drug-Free Workplace

  52.223-14   Aug 2003   Toxic Chemical Release Reporting (Over \$100,000)

  52.225-1    Jun 2003   Buy American Act - Supplies

  52.225-13   Dec 2003   Restrictions on Certain Foreign Purchases

  52.227-1    Jul 1995   Authorization and Consent, Alternate I (Apr 1984)

  52.227-2    Aug 1996   Notice and Assistance Regarding Patent and
                         Copyright Infringement (Over \$100,000)

  52.227-11   Jun 1997   Patent Rights - Retention by the Contractor (Short
                         Form) (Note: In accordance with FAR 27.303(a)(2),
                         paragraph (f) is modified to include the
                         requirements in FAR 27.303(a)(2)(i) through (iv).
                         The frequency of reporting in (i) is annual.

  52.229-3    Apr 2003   Federal, State and Local Taxes (Over \$100,000)

  52.232-2    Apr 1984   Payments under Fixed-Price Research and
                         Development Contracts

  52.232-9    Apr 1984   Limitation on Withholding of Payments

  52.232-17   Jun 1996   Interest (Over \$100,000)

  52.232-23   Jan 1986   Assignment of Claims

  52.232-25   Oct 2003   Prompt Payment

  52.232-33   Oct 2003   Payment by Electronic Funds Transfer\--Central
                         Contractor Registration

  52.233-1    Jul 2002   Disputes

  52.233-3    Aug 1996   Protest After Award

  52.242-13   Jul 1995   Bankruptcy (Over \$100,000)

  52.243-1    Aug 1987   Changes - Fixed Price, Alternate V (Apr 1984)

  52.244-2    Aug 1998   Subcontracts \*If written consent to subcontract
                         is required, the identified subcontracts are
                         listed in ARTICLE B, Advance Understandings.

  52.245-2    May 2004   Government Property (Fixed-Price Contracts)

  52.246-23   Feb 1997   Limitation of Liability (Over \$100,000)

  52.249-2    Sep 1996   Termination for the Convenience of the Government
                         (Fixed-Price)

  52.249-9    Apr 1984   Default (Fixed-Price Research and
                         Development)(Over \$100,000)

  52.253-1    Jan 1991   Computer Generated Forms
  ----------- ---------- --------------------------------------------------

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

  ----------------------- -------------------- --------------------------
  HHSAR CLAUSE NO.        DATE                 TITLE

  ----------------------- -------------------- --------------------------

  ---------------- ---------------- -------------------------------------
  352.202-1        Jan 2001         Definitions

  352.232-9        Apr 1984         Withholding of Contract Payments

  352.270-4        Jan 2001         Pricing of Adjustments

  352.270-6        Jul 1991         Publications and Publicity

  352.270-7        Jan 2001         Paperwork Reduction Act
  ---------------- ---------------- -------------------------------------

  -----------------------------------------------------------------------
  \[ End of GENERAL CLAUSES FOR A NEGOTIATED FIXED-PRICE RESEARCH AND
  DEVELOPMENT CONTRACT - Rev. 07/2004\].

  -----------------------------------------------------------------------

### 

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

> FAR Clause 52.232-1, PAYMENTS (APRIL 1984) is deleted in its entirety
> and FAR Clause 52.232-16, PROGRESS PAYMENTS (MARCH 2000) is
> substituted therefor.

### ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES

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

This contract incorporates the following clauses by reference, (unless
otherwise noted), with the same force and effect as if they were given
in full text. Upon request, the Contracting Officer will make their full
text available.

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

\(1\) FAR 52.215-17, Waiver of Facilities Capital Cost of Money (OCTOBER
1997).

\(2\) FAR 52.227-14, Rights in Data - General (JUNE 1987).

(3) FAR 52.230-2, Cost Accounting Standards (APRIL 1998).

\(4\) FAR 52.230-3, Disclosure and Consistency of Cost Accounting
Practices (APRIL 1998).

\(5\) FAR 52.230-6, Administration of Cost Accounting Standards
(NOVEMBER 1999).

\(6\) FAR 52.237-10, Indemnification of Uncompensated Overtime (OCTOBER
1997).

\(7\) FAR 52.247-64, Preference for Privately Owned U.S. Flag Commercial
Vessels (APRIL 2003).

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

HHSAR 352.270-5, Key Personnel (APRIL 1984).

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

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

NIH (RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB Bulletin
81-16).

### ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

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

This contract incorporates the following clauses in full text.

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

52.217-9 Option to Extend the Term of the Contract.

(March 2000)

\(a\) The Government may extend the term of this contract by written
notice to the Contractor within [fourteen (14) months]{.underline};
provided that the Government gives the Contractor a preliminary written
notice of its intent to extend at least [thirty]{.underline} ([30)
days]{.underline} before the contract expires. The preliminary notice
does not commit the Government to an extension.

\(b\) If the Government exercises this option, the extended contract
shall be considered to include this option clause.

\(c\) The total duration of this contract, including the exercise of any
options under this clause, shall not exceed [twenty-one (21)
months]{.underline}.

(End of clause)

[]{#F .anchor}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:

PROPOSAL SUBMISSION INSTRUCTIONS -- see:
[**http://www.niaid.nih.gov/contract/eproposal.htm**](http://www.niaid.nih.gov/contract/eproposal.htm)

PROPOSAL SUBMISSION: NUMBER OF COPIES AND PAGE LIMITATIONS (Attached to
this listing)

PROPOSAL INTENT RESPONSE SHEET (Attached to this listing)

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

RFP FORMS AND ATTACHMENTS:

> THE RFP FORMS/ATTACHMENTS LISTED BELOW ARE AVAILABLE IN A VARIETY OF
> FORMATS AND MAY BE VIEWED OR DOWNLOADED DIRECTLY FROM THIS SITE:

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

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

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

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

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

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

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

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

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

### 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):

### Invoice Instructions for NIH Fixed-Price Contracts, NIH(RC)-2, (11/03), 1 page  {#invoice-instructions-for-nih-fixed-price-contracts-nihrc-2-1103-1-page .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)}

**PROPOSAL SUBMISSION: NUMBER OF COPIES, PAGE LIMITATIONS AND ELECTRONIC
FILE SIZE**

**Please refer to <http://www.niaid.nih.gov/contract/eproposal.htm> for
delivery instructions for the submission of PAPER copies.**

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

**In addition to the paper submission, you are requested to submit your
proposal in PDF Searchable file, not image, on CD. 15 CDs are required:
copies of each technical and business proposal need to be on separate
CDs. No URLs in the proposal. [You must certify that both the original
paper and electronic versions of the proposal are
identical]{.underline}.**

[SUBMISSION OF PROPOSALS BY FACSIMILE IS NOT ACCEPTABLE.]{.underline}

NUMBER OF PAPER COPIES:

The number of copies required of each part of your proposal are as
specified below.

+-------------+------------------------+---------------+---------------+
| Document    | Number of Copies       | Page Limits   | File Size     |
+-------------+------------------------+---------------+---------------+
| Technical   | One (1) unbound signed | Limited to    | Limited to    |
| Proposal    | original.              | not-to-exceed | not-to-exceed |
|             |                        | 50 pages      | 4 mega-bytes  |
|             | Fifteen (15) unbound   | []{.mark}     |               |
|             | copies.                |               |               |
+-------------+------------------------+---------------+---------------+
| Business    | One (1) unbound signed | included in   | Included in   |
| Proposal    | original.              | the Technical | the Technical |
|             |                        | Proposal Page | Proposal File |
|             | Fifteen (15) unbound   | Limits        | Size          |
|             | copies.                |               |               |
+-------------+------------------------+---------------+---------------+
| Repr        | One (1) Original       | N/A           | N/A           |
| esentations | required to be         |               |               |
| and         | submitted with the     |               |               |
| Cer         | Original Business      |               |               |
| tifications | Proposal. (Extra       |               |               |
|             | copies are optional.)  |               |               |
+-------------+------------------------+---------------+---------------+
| Proposal    | Sixteen (16) unbound   | Limit to      | []{.mark}     |
| Appendices  | copies of all          | not-to-exceed |               |
|             | materials not          | 50 pages      | N/A           |
| (Optional)  | available              |               |               |
|             | electronically (i.e.   |               |               |
|             | SOPs, Pertinent        |               |               |
|             | Manuals, Nonscannable  |               |               |
|             | Figures or Data, and   |               |               |
|             | Fac                    |               |               |
|             | ilities/Descriptions). |               |               |
+-------------+------------------------+---------------+---------------+
| Resumes     | Sixteen (16) unbound   | Limited to 2  | N/A           |
|             | copies                 | pages per     |               |
|             |                        | person        |               |
+-------------+------------------------+---------------+---------------+

WARNING: You are advised to read and carefully follow the instructions
listed in each 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.

PROPOSAL INTENT RESPONSE SHEET

RFP No.: NIH-NIAID-DAIT-05-46

RFP Title: 'Development of Improved DTPA for Radionuclide Chelation'

Please review the attached Request for Proposal. Furnish the information
requested below and return this page by [May 17, 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:]{.mark}

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, MSC 7612

6700 B Rockledge Drive

Bethesda, Maryland 20892-7612

Attn: Donald E. Collie

RFP-NIH-NIAID-DAIT-05-46\
FAX# (301) 480-4675

E-mail: <dc128b@nih.gov>

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

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

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

REPRESENTATIONS AND CERTIFICATIONS

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

<http://rcb.cancer.gov/rcb-internet/forms/rcneg.pdf>

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

IF YOU INTEND TO SUBMIT A PROPOSAL, YOU MUST COMPLETE AND SUBMIT ONE
ORIGINAL OF THE REPRESENTATIONS AND CERTIFICATIONS AND SUBMIT IT AS PART
OF YOUR ORIGINAL BUSINESS PROPOSAL. ADDITIONALLY, A COMPLETED ORIGINAL
MUST BE SUBMITTED FOR ANY PROPOSED SUBCONTRACTORS.

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

### 1. GENERAL INFORMATION

Alternate I (October 1997). As prescribed in 15.209(a)(1), substitute
the following paragraph (f)(4) for paragraph (f)(4) of the basic
provision:

\(f\) (4) The Government intends to evaluate proposals and award a
contract after conducting discussions with offerors whose proposals have
been determined to be within the competitive range. If the Contracting
Officer determines that the number of proposals that would otherwise be
in the competitive range exceeds the number at which an efficient
competition can be conducted, the Contracting Officer may limit the
number of proposals in the competitive range to the greatest number that
will permit an efficient competition among the most highly rated
proposals. Therefore, the offeror\'s initial proposal should contain the
offeror\'s best terms from a price and technical standpoint.

a\. 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.

The North American Industry Classification System (NAICS) code for this
acquisition is [541710]{.underline} .

The small business size standard is [500 employees]{.underline} .

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.

b\. TYPE OF CONTRACT AND NUMBER OF AWARD(S)

> It is anticipated that [MULITPLE AWARDS]{.underline} will be made from
> this solicitation and that the award will be made on/about [September
> 30, 2005]{.underline}.
>
> It is anticipated that the award from this solicitation will be a
> FIXED PRICE type contract with Options for a PERIOD OF PERFORMANCE OF
> 21 MONTHS, BEGINNING ON/ABOUT SEPTEMBER 30 2005.

c\. COMMITMENT OF PUBLIC FUNDS

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

d\. COMMUNICATIONS PRIOR TO CONTRACT AWARD

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

e\. RELEASE OF INFORMATION

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

f\. 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.

g\. PREPARATION COSTS

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

h\. SERVICE OF PROTEST (AUGUST 1996) - FAR 52.233-2

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

Contracting Officer: See Block 15 of RFP Cover Page

Address: See Block 9 of RFP Cover Page

> \(b\) The copy of any protest shall be received in the office
> designated above within one day of filing a protest with the GAO.

(End of Provision)

### 2. INSTRUCTIONS TO OFFERORS

#### 

#### a. GENERAL INSTRUCTIONS 

INTRODUCTION

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

\(1\) [Contract Type and General Clauses]{.underline}

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

\(2\) [Authorized Official and Submission of Proposal]{.underline}

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

I. COVER PAGE

> Include RFP title, number, name of organization, identification of the
> proposal part, and indicate whether an original or a copy.

Project Objectives, NIH-1688-1

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

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

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

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

II\. TECHNICAL PROPOSAL

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

III\. BUSINESS PROPOSAL

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

\(3\) [Proposal Summary and Data Record (NIH-2043)]{.underline}

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

\(4\) [Separation of Technical and Business Proposals]{.underline}

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

\(5\) [Evaluation of Proposal]{.underline}

> The Government will evaluate the technical proposal in accordance with
> the criteria set forth in PART IV, SECTION M of this RFP.

\(6\) [Potential Award Without Discussions]{.underline}

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

\(7\) [Use of the Metric System of Measurement]{.underline}

> It is the policy of the Department of Health and Human Services to
> support the Federal transition to the metric system and to use the
> metric system of measurement in all procurements, grants, and other
> business related activities unless such use is impracticable or is
> likely to cause significant inefficiencies.
>
> The offeror is encouraged to prepare their proposal using either
> \"Hard Metric,\" \"Soft Metric,\" or \"Dual Systems\" of measurement.
> The following definitions are provided for your information:
>
> [Hard Metric]{.underline} - The replacement of a standard inch-pound
> size with an accepted metric size for a particular purpose. An example
> of size substitution might be: selling or packaging liquids by the
> liter instead of by the pint or quart (as for soft drinks), or instead
> of by the gallon (as for gasoline).
>
> [Soft Metric]{.underline} - The result of a mathematical conversion of
> inch-pound measurements to metric equivalents for a particular
> purpose. The physical characteristics are not changed.
>
> [Dual Systems]{.underline} - The use of both inch-pound and metric
> systems. For example, an item is designed, produced, and described in
> inch-pound values with soft metric values also shown for information
> or comparison purposes.

\(8\) [Selection of Offeror]{.underline}

> \(a\) The acceptability of the scientific and technical portion of
> each research contract proposal will be evaluated by a technical
> review committee. The committee will evaluate each proposal in strict
> conformity with the evaluation criteria of the RFP, utilizing point
> scores and written critiques. The committee may suggest that the
> Contracting Officer request clarifying information from an offeror.
>
> \(b\) The business portion of each contract proposal will be subjected
> to a cost and price analysis, management analysis, etc.
>
> (c ) If award will be made without conducting discussions, offerors
> may be given the opportunity to clarify certain aspects of their
> proposal (e.g., the relevance of an offeror\'s past performance
> information and adverse past performance information to which the
> offeror has not previously had an opportunity to respond) or to
> resolve minor or clerical errors.

\(d\) If the Government intends to conduct discussions prior to awarding
a contract-

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

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

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

> While it is this Institute's policy to conduct discussions with all
> offerors in the competitive range, the Institute reserves the right,
> in special circumstances, to limit the number of proposals included in
> the competitive range to the greatest number that will permit an
> efficient competition. All aspects of the proposals are subject to
> discussions, including cost, technical approach, past performance, and
> contractual terms and conditions. At the conclusion of discussions,
> each offeror still in the competitive range shall be given an
> opportunity to submit a written Final Proposal Revision (FPR) with the
> reservation of the right to conduct finalization of details with the
> selected sources in accordance with HHSAR 315.370.
>
> \(e\) The process described in FAR 15.101-1 will be employed, which
> permits the Government to make tradeoffs among cost or price and
> non-cost factors and to consider award to other than the lowest price
> offeror or other than the highest technically rated offeror. This
> process will take into consideration the results of the technical
> evaluation, the past performance evaluation (if applicable) and the
> cost analysis.
>
> \(f\) The Institute reserves the right to make a single award,
> multiple awards, or no award at all to the RFP. In addition, the RFP
> may be amended or canceled as necessary to meet the Institute's
> requirements. Synopses of awards exceeding \$25,000 will be published
> in the FedBizOpps.

\(9\) [Salary Rate Limitation in Fiscal Year 2005]{.underline}

> Offerors are advised that pursuant to P.L. 108-447, Title II, General
> Provisions, Section 204, no NIH Fiscal Year 2005 (October 1, 2004 -
> September 30, 2005) funds may be used to pay the direct annual salary
> of an individual through any contract awarded as a result of this
> solicitation at a rate in excess of the Executive Schedule, Level I
> (direct salary is exclusive of Overhead, Fringe Benefits and General
> and Administrative expenses, also referred to as \"indirect cost\" or
> \"facilities and administrative (F&A) costs\"). Direct salary has the
> same meaning as the term \"institutional base salary.\" An
> individual\'s direct salary (or institutional base salary) is the
> annual compensation that the contractor pays for an individual\'s
> appointment whether that individual\'s time is spent on research,
> teaching, patent care or other activities. Direct salary (or
> institutional base salary) excludes any income that an individual may
> be permitted to earn outside of duties to the contractor.
>
> This does not preclude the offeror from absorbing that portion of an
> employee\'s annual salary (plus the dollar amount for fringe benefits
> and associated indirect costs) that exceeds a rate of the Executive
> Schedule, Level I. The salary rate limitation set by P.L. 108-447
> applies only to Fiscal Year 2005 funds, however, salary rate ceilings
> for subsequent years may be included in future DHHS appropriation
> acts. Multi-year contracts awarded pursuant to this solicitation may
> be subject to unilateral modifications by the Government if an
> individual\'s annual salary exceeds any salary rate ceiling
> established in future appropriations acts. The Executive Schedule,
> Level I annual salary rate limit also applies to individuals proposed
> under subcontracts, however it does not apply to consultants. P.L.
> 108-447 states in pertinent part:
>
> \"None of the funds appropriated in this Act for the National
> Institutes of Health, the Agency for Healthcare Research and Quality,
> and the Substance Abuse, and Mental Health Services Administration
> shall be used to pay the salary of an individual through a grant or
> extramural mechanism at a rate in excess of Executive Level I.\"

*LINK TO EXECUTIVE SCHEDULE SALARIES:* \<
<http://www.opm.gov/oca/05tables/html/ex.asp> \>

(click on \"Executive Schedule\" for the current Fiscal Year\'s salary
rate or scroll down to the \"General Schedule Salary Tables from
Previous Years\" to locate the Executive Level salary rates from
previous years).

\(10\) [Solicitation Provisions Incorporated by Reference, FAR 52.252-1
(February 1998)]{.underline}

> This Solicitation incorporates one or more solicitation provisions by
> reference, with the same force and effect as if they were given in
> full text. Upon request, the Contracting Officer will make their full
> text available. The offeror is cautioned that the listed provisions
> may include blocks that must be completed by the offeror and submitted
> with its quotation or offer. In lieu of submitting the full text
> provisions, the offeror may identify the provision by paragraph
> identifier and provide the appropriate information with its quotation
> or offer. Also, the full text of a solicitation provision may be
> accessed electronically at this address: <http://www.arnet.gov/far/>.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1):

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).

\(11\) [Prohibition on Contractor Involvement with Terrorist
Activities]{.underline}

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

###  {#section-4 .Normal-Bold-(bullet)}

###  Office of Health and Safety -- Laboratory Registration / Select Agent Transfer Program {#office-of-health-and-safety-laboratory-registration-select-agent-transfer-program .Normal-Bold-(bullet)}

> The awardee is responsible for ensuring that all work under this
> grant, cooperative agreement, or contract complies with all Federal
> requirements related to select agents including CDC's that can be
> found at <http://www.cdc.gov/od/ohs/lrsat.htm> and NIH\'s OBA that can
> be found at
> <http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-052.html>
> .

#### b. TECHNICAL PROPOSAL INSTRUCTIONS 

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

1\. [Technical Discussions]{.underline}

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

\(a\) **Statement of Work**

\(1\) [Objectives]{.underline}

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

\(2\) [Approach]{.underline}

> Use as many subparagraphs, appropriately titled, as needed to clearly
> outline the general plan of work. Discuss phasing of research and, if
> appropriate, include experimental design and possible or probable
> outcome of approaches proposed.

\(3\) [Methods]{.underline}

> Describe in detail the methodologies you will use for the project,
> indicating your level of experience with each, areas of anticipated
> difficulties, and any unusual expenses you anticipate.

\(4\) [Schedule]{.underline}

> Provide a schedule for completion of the work and delivery of items
> specified in the statement of work. Performance or delivery schedules
> shall be indicated for phases or segments, as applicable, as well as
> for the overall program. Schedules shall be shown in terms of calendar
> months from the date of authorization to proceed or, where applicable,
> from the date of a stated event, as for example, receipt of a required
> approval by the Contracting Officer. Unless the request for proposal
> indicates that the stipulated schedules are mandatory, they shall be
> treated as desired or recommended schedules. In this event, proposals
> based upon the offeror\'s best alternative schedule, involving no
> overtime, extra shift or other premium, will be accepted for
> consideration.

\(b\) **Personnel**

> Describe the experience and qualifications of personnel who will be
> assigned for direct work on this program. Information is required
> which will show the composition of the task or work group, its general
> qualifications, and recent experience with similar equipment or
> programs. Special mention shall be made of direct technical
> supervisors and key technical personnel, and the approximate
> percentage of the total time each will be available for this program.
>
> OFFERORS SHOULD ASSURE THAT THE PRINCIPAL INVESTIGATOR, AND ALL OTHER
> PERSONNEL PROPOSED, SHALL NOT BE COMMITTED ON FEDERAL GRANTS AND
> CONTRACTS FOR MORE THAN A TOTAL OF 100% OF THEIR TIME. IF THE
> SITUATION ARISES WHERE IT IS DETERMINED THAT A PROPOSED EMPLOYEE IS
> COMMITTED FOR MORE THAN 100% OF HIS OR HER TIME, THE GOVERNMENT WILL
> REQUIRE ACTION ON THE PART OF THE OFFEROR TO CORRECT THE TIME
> COMMITMENT.

\(1\) [Principal Investigator/Project Director]{.underline}

> List the name of the Principal Investigator/Project Director
> responsible for overall implementation of the contract and key contact
> for technical aspects of the project. Even though there may be
> co-investigators, identify the Principal Investigator/Project Director
> who will be responsible for the overall implementation of any awarded
> contract. Discuss the qualifications, experience, and accomplishments
> of the Principal Investigator/Project Director. State the estimated
> time to be spent on the project, his/her proposed duties, and the
> areas or phases for which he/she will be responsible.

\(2\) [Other Investigators]{.underline}

> List all other investigators/professional personnel who will be
> participating in the project. Discuss the qualifications, experience,
> and accomplishments. State the estimated time each will spend on the
> project, proposed duties on the project, and the areas or phases for
> which each will be responsible.

\(3\) [Additional Personnel]{.underline}

> List names, titles, and proposed duties of additional personnel, if
> any, who will be required for full-time employment, or on a
> subcontract or consultant basis. The technical areas, character, and
> extent of subcontract or consultant activity will be indicated and the
> anticipated sources will be specified and qualified. For all proposed
> personnel who are not currently members of the offeror\'s staff, a
> letter of commitment or other evidence of availability is required. A
> resume does not meet this requirement. Commitment letters for use of
> consultants and other personnel to be hired must include:

-   The specific items or expertise they will provide.

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

-   Willingness to act as a consultant.

-   How rights to publications and patents will be handled.

\(4\) [Resumes]{.underline}

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

2\. [Technical Evaluation]{.underline}

> Proposals will be technically evaluated in accordance with the factors
> and order of relative importance as described in the Technical
> Evaluation Criteria (SEE SECTION M).

3\. [Additional Technical Proposal Information]{.underline}

1)  Proposals that merely offer to conduct a program in accordance with
    the requirements of the Government's statement of work will not be
    eligible for award. The technical proposal should contain an
    explanation of the proposed technical approach in conjunction with
    the tasks to be performed in achieving the project objectives.

2)  The technical proposal must contain letter(s) that document access
    to the proposed starting material, and specific data characterizing
    the starting material.

3)  A detailed work plan must be submitted indicating how each aspect of
    the statement of work is to be accomplished. The plan should be in
    as much detail as considered necessary to fully explain your
    proposed technical approach or method. The work plan should include
    a detailed Gant Chart. The technical proposal should reflect a clear
    understanding of the nature of the work being undertaken.

4)  The technical proposal must include information on how the project
    is to be organized, staffed, and managed. This information should
    demonstrate your understanding of important events or tasks and
    their management. You must explain how the management and
    coordination of consultant and/or subcontractor efforts will be
    accomplished.

5)  The technical proposal must list the names and proposed duties of
    the professional personnel, consultants, and key subcontractor
    employees assigned to the project. Their resumes should be included
    and should contain information on education, background, recent
    experience, and specific or technical accomplishments. The
    approximate percentage of time each individual should be allocated
    against each project task or subtask. The technical proposal should
    not include names of advisors, consultants, collaborators, or
    subcontractors that have not been contacted by the offeror and for
    which there is not letter of agreement to participate included in
    the offer.

6)  The technical proposal must provide the general background,
    experience and qualifications of the organization. Similar or
    related contracts, subcontracts, or grants should be included and
    contain the name of the customer, contractor grant number, dollar
    amount, time of performance, and the names and telephone numbers of
    the project officer and contracting officer/grants officer. The
    technical proposal should describe experience with FDA regulated
    products of a similar nature.

7)  The technical proposal must contain a description of facilities and
    equipment that will be used to perform the contract. In addition,
    the technical proposal shall contain a letter to document an
    agreement to a pre-award site visit of an offerors facility, if the
    Government deems necessary. This letter needs to be signed by an
    authorized official of the offeror.

8)  The technical proposal should include a summary of total costs only.
    It should not contain reference to detailed cost.

> The technical proposal must be prepared and submitted in the following
> format to facilitate proposal evaluation. The technical proposal
> should include a separate section addressing (1) access to and
> characterization of proposed starting material; (2) the offerors
> methodology and technical approach to produce the contract
> deliverables including a detailed Gant chart; (3) the offerors
> management plan and personnel (resumes may be provided in an
> appendix); (4) a separate section addressing the offerors facilities;
> and (5) a summary budget.

4\. [Other Considerations]{.underline}

> Record and discuss specific factors not included elsewhere which
> support your proposal. Using specifically titled subparagraphs, items
> may include:
>
> \(a\) Any agreements and/or arrangements with subcontractor(s).
> Provide as much detail as necessary to explain how the statement of
> work will be accomplished within this working relationship.
>
> \(b\) Unique arrangements, equipment, etc., which none or very few
> organizations are likely to have which is advantageous for effective
> implementation of this project.
>
> (c ) Equipment and unusual operating procedures established to protect
> personnel from hazards associated with this project.

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

> \(e\) Recommendations for changing reporting requirements if such
> changes would be more compatible with the offeror\'s proposed
> schedules.

#### c. BUSINESS PROPOSAL INSTRUCTIONS

1\. **Basic Cost/Price Information**

> The business proposal must contain sufficient information to allow the
> Government to perform a basic analysis of the proposed cost or price
> of the work. This information shall include the amounts of the basic
> elements of the proposed cost or price. These elements will include,
> as applicable, direct labor, fringe benefits, travel, materials,
> subcontracts, purchased parts, shipping, indirect costs and rate, fee,
> and profit.
>
> Cost proposals should provide a breakdown of costs for each Phase 1
> and Phase 2 as described under Statement of Work section, as well as a
> monthly and total cost estimate for the entire project. The proposal
> must include a detailed Gantt chart that provides timelines
> delineating each milestone and associated tasks.
>
> []{.mark}

2\. **Qualifications of the Offeror**

You are requested to submit a summary of your \"General Experience,
Organizational Experience Related to this RFP, Performance History and
Pertinent Contracts.\"

\(a\) [General Experience]{.underline}

> General experience is defined as general background, experience and
> qualifications of the offeror. A discussion of proposed facilities
> which can be devoted to the project may be appropriate.

\(b\) [Organizational Experience Related to the RFP]{.underline}

> Organizational experience is defined as the accomplishment of work,
> either past or on-going, which is comparable or related to the effort
> required by this RFP. This includes overall offeror or corporate
> experience, but not the experience and/or past performance of
> individuals who are proposed as personnel involved with the Statement
> of Work in this RFP.

(c ) [Performance History]{.underline}

> [Performance history]{.underline} is defined as meeting contract
> objectives within delivery and [cost schedules]{.underline} on
> efforts, either past or on-going, which is comparable or related to
> the effort required by this RFP.

\(d\) [Pertinent Contracts]{.underline}

> Pertinent contracts is defined as a listing of each related contract
> completed within the last three years or currently in process. The
> listing should include: 1) the contract number; 2) contracting agency;
> 3) contract dollar value; 4) dates contract began and ended (or ends);
> 5) description of contract work; 6) explanation of relevance of work
> to this RFP; 7) actual delivery and cost performance versus delivery
> and cost agreed to in the contract(s). For award fee contracts,
> separately state in dollars the base fee and award fee available and
> the award fee actually received. The same type of organizational
> experience and past performance data should be submitted.

\(e\) [Pertinent Grants]{.underline}

> List grants supported by the Government that involved similar or
> related work to that called for in this RFP. Include the grant number,
> involved agency, names of the grant specialist and the Science
> Administrator, identification of the work, and when performed.
>
> You are cautioned that omission or an inadequate or inaccurate
> response to this very important RFP requirement could have a negative
> effect on the overall selection process. Experience and past
> performance are factors which are relevant to the ability of the
> offerors to perform and are considered in the source selection
> process.

3\. **Other Administrative Data**

\(a\) [Property]{.underline}

\(1\) It is DHHS policy that Contractors will provide all equipment and
facilities necessary for performance of contracts. Exception may be
granted to furnish Government-owned property, or to authorize purchase
with contract funds, only when approved by the Contracting Officer. If
the offeror is proposing that the Government provide any equipment,
other than that specified under Government Furnished Property in the
RFP, the proposal must include comprehensive justification which
includes:

a\) An explanation that the item is for a special use essential to the
direct performance of the contract and the item will be used exclusively
for the purpose. Office equipment such as desks, office machines, etc.,
will not be provided under a contract except under very exceptional
circumstances.

b\) No practical or economical alternative exists (e.g., rental, capital
investment) that can be used to perform the work.

\(2\) The offeror shall identify Government-owned property in its
possession and/or Contractor titled property acquired from Federal
funds, which it proposes to use in the performance of the prospective
contract.

\(3\) The management and control of any Government property shall be in
accordance with DHHS Publication (OS) 686 entitled, \"Contractors Guide
for Control of Government Property (1990),\" a copy of which will be
provided upon request.

\(b\) [Submission of Electronic Funds Transfer Information with Offer,
FAR Clause 52.232-38 (MAY 1999)]{.underline}

> The offeror shall provide, with its offer, the following information
> that is required to make payment by electronic funds transfer (EFT)
> under any contract that results from this solicitation. This
> submission satisfies the requirement to provide EFT information under
> paragraphs (b)(1) and (j) of the clause at 52.232‑34, Payment by
> Electronic Funds Transfer‑‑Other than Central Contractor Registration.

\(1\) The solicitation number (or other procurement identification
number).

\(2\) The offeror\'s name and remittance address, as stated in the
offer.

\(3\) The signature (manual or electronic, as appropriate), title, and
telephone number of the offeror\'s official authorized to provide this
information.

\(4\) The name, address, and 9‑digit Routing Transit Number of the
offeror\'s financial agent.

\(5\) The offeror\'s account number and the type of account (checking,
savings, or lockbox).

\(6\) If applicable, the Fedwire Transfer System telegraphic
abbreviation of the offeror\'s financial agent.

\(7\) If applicable, the offeror shall also provide the name, address,
telegraphic abbreviation, and 9‑digit Routing Transit Number of the
correspondent financial institution receiving the wire transfer payment
if the offeror\'s financial agent is not directly on‑line to the Fedwire
and, therefore, not the receiver of the wire transfer payment.

\(c\) [Financial Capacity]{.underline}

> The offeror shall indicate if it has the necessary financial capacity,
> working capital, and other resources to perform the contract without
> assistance from any outside source. If not, indicate the amount
> required and the anticipated source.

\(d\) [Facilities Capital Cost of Money, FAR 52.215-16, (October
1997)]{.underline}

(This is applicable if you are a commercial organization.)

> Facilities capital cost of money \[(see FAR 15.408(h)\] will be an
> allowable cost under the contemplated contract, if the criteria for
> allowability in subparagraph 31.205-10(a)(2) of the Federal
> Acquisition Regulation are met. One of the allowability criteria
> requires the prospective Contractor to propose facilities capital cost
> of money in its offer.
>
> If the prospective Contractor does not propose this cost, the
> resulting contract will include the clause Waiver of Facilities
> Capital Cost of Money.

(End of Provision)

> If the offeror elects to claim this cost, the offeror shall
> specifically identify or propose it in the cost proposal for the
> contract by checking the appropriate box below.
>
> \[ \] The prospective Contractor has specifically identified or
> proposed facilities capital cost of money in its cost proposal and
> elects to claim this cost as an allowable cost under the contract.
> Submit Form CASB-CMF (see FAR 31.205-10).
>
> \[ \] The prospective Contractor has not specifically identified or
> proposed facilities capital cost of money in its proposal and elects
> not to claim it as an allowable cost under the contract.

4\. [Subcontractors]{.underline}

If subcontractors are proposed, please include a commitment letter from
the subcontractor detailing:

a\) Willingness to perform as a subcontractor for specific duties (list
duties).

b\) What priority the work will be given and how it will relate to other
work.

c\) The amount of time and facilities available to this project.

d\) Information on their cognizant field audit offices.

e\) How rights to publications and patents are to be handled.

f\) A complete cost proposal in the same format as the offeror\'s cost
proposal.

> [Note]{.underline}: Organizations that plan to enter into a
> subcontract with an educational concern under a contract awarded under
> this RFP should refer to the following Web Site for a listing of
> clauses that are required to be incorporated in Research & Development
> (R&D) subcontracts with educational institutions:

5\. [Proposer\'s Annual Financial Report]{.underline}

> A copy of the organization\'s most recent annual report must be
> submitted as part of the business proposal.

6\. [Representations and Certifications]{.underline}

> One copy of the Representations and Certifications attached as Section
> K shall be completed and be signed by an official authorized to bind
> your organization. Additionally, a completed copy of the
> Representations and Certifications shall be submitted from any
> proposed subcontractor.

7\. [Travel Costs/Travel Policy]{.underline}

Travel Policy

> One copy of the offeror\'s (and any proposed subcontractor\'s) written
> travel policy shall be included in the business proposal (original
> only). If an offeror (or any proposed subcontractor) does not have a
> written travel policy, the offeror shall so state.

8\. [Certification of Visa's for Non-U.S. Citizens]{.underline}

Proposed personnel under research projects are not required to be
citizens of the United States. However, if non-U.S. citizens are
proposed under a contract to be performed in the United States and its
territories, then the offeror must indicate in the proposal that these
individuals have the required visas.

######## **SECTION M - EVALUATION FACTORS FOR AWARD**

**1. GENERAL**

Selection of an Offeror for contract award will be based on an
evaluation of proposals against three factors. The factors in order of
importance are: (1) technical merit and (2) cost and (3) past
performance. Although technical factors are of paramount consideration
in the award of the contract, cost is also important to the overall
contract award decision; however, all evaluation factors other than cost
or price, when combined, are significantly more important than cost or
price. In any case, the Government reserves the right to make an award
to that Offeror whose proposal provides the best overall value to the
Government. In accordance with FAR 15.3, the award will be subject to a
cost realism analysis by the Government. The NIAID reserves the right to
make an award without discussions.

The evaluation will be based on the demonstrated capabilities of the
prospective Offerors in relation to the needs of the project as set
forth in the RFP. The merits of each proposal will be carefully
evaluated. Each proposal must document the feasibility of its plan to
successfully achieve the objectives of the RFP. Offeror must submit
information sufficient to evaluate their proposals based on the detailed
criteria listed below.

**2. TECHNICAL EVALUATION CRITERIA**

The technical evaluation committee will use these evaluation criteria
when reviewing the technical proposals. Proposals will be judged solely
on the written material provided by the Offeror. The criteria below are
listed in the order of relative importance with weights assigned for
evaluation purposes.

**CRITERIA**

**Scientific and Technical Approach to Statement of Work Points: 60**

Technical approaches for proposals submitted will be evaluated with
respect to the following:

1\) Technical adequacy and feasibility of proposed screening strategy
(as proposed in the Statement of Work -- Phase 1) to determine lead
candidates and technical adequacy and feasibility of analytical methods
to be used to detect, differentiate and quantitate DTPA and modified
DTPA (if applicable) and chelated target molecule(s) (25 points)

2\) Technical adequacy and feasibility of proposed methods for in vivo
testing of the lead candidates (as proposed in the Statement of Work --
Phase 2) for proof of concept (bioavailability and efficacy). (20
points)

3\) Comprehensiveness of the approach and scientific soundness of the
methodology proposed to develop and synthesize DTPA prodrug(s),
formulation(s) or delivery method(s) for DTPA and plans for cGMP
production as described in the Statement of Work. (15 points)

**Personnel Qualifications Points: 30**

1\) Documented evidence of the qualifications, experience, and
availability of Principal Investigator in managing drug development
projects, preferably in the field of metal chelation. (15 points)

2\) Documented evidence of the qualifications, experience, and
availability of all technical personnel in working with drug development
tasks; in particular, compound synthesis, detection assay development,
pharmacology and metal chelation assays. Adequacy of the management
plan, staffing and organizational structure. (15 points)

**Facilities and Resources Points: 10**

Adequacy and availability of appropriate laboratories, and animal care
facilities (including AAALAC accreditation or equivalent), equipment,
and resources, including radiation licensing and safety procedures,
necessary to safely and efficiently accomplish the studies proposed.
Also, an offeror needs to provide a letter, signed by an authorized
official, indicating their agreement to a pre-award site visit of their
facility. The Government reserves the right to perform a pre-award site
audit, if necessary.

**Total: 100 Points**

**3. EVALUATION OF PAST PERFORMANCE**

An evaluation of Offeror's past performance information will be
conducted subsequent to the technical evaluation. However, this
evaluation will not be conducted on any Offeror whose proposal would not
be selected for award based on 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.

**4. PRE-AWARD SITE AUDIT**

An evaluation of the adequacy of the facilities and resources provided
by the Offeror may be conducted at the discretion of the Government
prior to award. When assessing the facilities and resources, the
Government will focus on the adequacy and availability of appropriate
laboratories, equipment and animal care facilities and will include an
audit of the Offeror's radiation licensing and safety procedures.

**\[END OF SOLICITATION PACKAGE\]**