**[Institutional Review Board (IRB)]{.smallcaps}**

**[Request for Amendment Approval of Protocol]{.smallcaps}**

**Date Rec'd in HSO **[ ]{.underline}

+------------------------------------------------------------+---+---+
| +---------------------------------------------+---+---+    |   |   |
| | +---------------------------------------+   |   |   |    |   |   |
| | | +-----------------------------+---+   |   |   |   |    |   |   |
| | | | +---------------+---+---+   |   |   |   |   |   |    |   |   |
| | | | | **In          |   |   |   |   |   |   |   |   |    |   |   |
| | | | | structions**: |   |   |   |   |   |   |   |   |    |   |   |
| | | | | Use this form |   |   |   |   |   |   |   |   |    |   |   |
| | | | | to submit any |   |   |   |   |   |   |   |   |    |   |   |
| | | | | changes to    |   |   |   |   |   |   |   |   |    |   |   |
| | | | | your          |   |   |   |   |   |   |   |   |    |   |   |
| | | | | research.     |   |   |   |   |   |   |   |   |    |   |   |
| | | | | Please submit |   |   |   |   |   |   |   |   |    |   |   |
| | | | | this form     |   |   |   |   |   |   |   |   |    |   |   |
| | | | | e             |   |   |   |   |   |   |   |   |    |   |   |
| | | | | lectronically |   |   |   |   |   |   |   |   |    |   |   |
| | | | | along with a  |   |   |   |   |   |   |   |   |    |   |   |
| | | | | copy of the   |   |   |   |   |   |   |   |   |    |   |   |
| | | | | protocol,     |   |   |   |   |   |   |   |   |    |   |   |
| | | | | current       |   |   |   |   |   |   |   |   |    |   |   |
| | | | | consent form, |   |   |   |   |   |   |   |   |    |   |   |
| | | | | and any       |   |   |   |   |   |   |   |   |    |   |   |
| | | | | supporting    |   |   |   |   |   |   |   |   |    |   |   |
| | | | | documents to  |   |   |   |   |   |   |   |   |    |   |   |
| | | | | the CIO       |   |   |   |   |   |   |   |   |    |   |   |
| | | | | designated    |   |   |   |   |   |   |   |   |    |   |   |
| | | | | staff         |   |   |   |   |   |   |   |   |    |   |   |
| | | | | official.     |   |   |   |   |   |   |   |   |    |   |   |
| | | | | However, if   |   |   |   |   |   |   |   |   |    |   |   |
| | | | | submitted in  |   |   |   |   |   |   |   |   |    |   |   |
| | | | | hardcopy,     |   |   |   |   |   |   |   |   |    |   |   |
| | | | | please send   |   |   |   |   |   |   |   |   |    |   |   |
| | | | | the original  |   |   |   |   |   |   |   |   |    |   |   |
| | | | | and three     |   |   |   |   |   |   |   |   |    |   |   |
| | | | | copies of all |   |   |   |   |   |   |   |   |    |   |   |
| | | | | documents to  |   |   |   |   |   |   |   |   |    |   |   |
| | | | | the CIO       |   |   |   |   |   |   |   |   |    |   |   |
| | | | | designated    |   |   |   |   |   |   |   |   |    |   |   |
| | | | | staff         |   |   |   |   |   |   |   |   |    |   |   |
| | | | | official.     |   |   |   |   |   |   |   |   |    |   |   |
| | | | | Consecutively |   |   |   |   |   |   |   |   |    |   |   |
| | | | | number        |   |   |   |   |   |   |   |   |    |   |   |
| | | | | **ALL**       |   |   |   |   |   |   |   |   |    |   |   |
| | | | | pages,        |   |   |   |   |   |   |   |   |    |   |   |
| | | | | beginning     |   |   |   |   |   |   |   |   |    |   |   |
| | | | | with the      |   |   |   |   |   |   |   |   |    |   |   |
| | | | | title page of |   |   |   |   |   |   |   |   |    |   |   |
| | | | | the protocol, |   |   |   |   |   |   |   |   |    |   |   |
| | | | | followed by   |   |   |   |   |   |   |   |   |    |   |   |
| | | | | any consent   |   |   |   |   |   |   |   |   |    |   |   |
| | | | | form(s) and   |   |   |   |   |   |   |   |   |    |   |   |
| | | | | ancillary     |   |   |   |   |   |   |   |   |    |   |   |
| | | | | documents.    |   |   |   |   |   |   |   |   |    |   |   |
| | | | | Complete all  |   |   |   |   |   |   |   |   |    |   |   |
| | | | | applicable    |   |   |   |   |   |   |   |   |    |   |   |
| | | | | items or the  |   |   |   |   |   |   |   |   |    |   |   |
| | | | | form will be  |   |   |   |   |   |   |   |   |    |   |   |
| | | | | returned.     |   |   |   |   |   |   |   |   |    |   |   |
| | | | +---------------+---+---+   |   |   |   |   |   |    |   |   |
| | | | |               |   |   |   |   |   |   |   |   |    |   |   |
| | | | +---------------+---+---+   |   |   |   |   |   |    |   |   |
| | | |                             |   |   |   |   |   |    |   |   |
| | | | **Date Submitted by         |   |   |   |   |   |    |   |   |
| | | | Investigator:** [           |   |   |   |   |   |    |   |   |
| | | | ]{.underline}               |   |   |   |   |   |    |   |   |
| | | +-----------------------------+---+   |   |   |   |    |   |   |
| | |                                       |   |   |   |    |   |   |
| | | **[Protocol No.]{.smallcaps}** [      |   |   |   |    |   |   |
| | | ]{.underline}                         |   |   |   |    |   |   |
| | +---------------------------------------+   |   |   |    |   |   |
| | |                                       |   |   |   |    |   |   |
| | +---------------------------------------+   |   |   |    |   |   |
| |                                             |   |   |    |   |   |
| | **Title of Protocol:** [ ]{.underline}      |   |   |    |   |   |
| +---------------------------------------------+---+---+    |   |   |
| |                                             |   |   |    |   |   |
| +---------------------------------------------+---+---+    |   |   |
|                                                            |   |   |
| Proposed Dates for Project - Begin: [ ]{.underline} End: [ |   |   |
| ]{.underline}                                              |   |   |
+------------------------------------------------------------+---+---+
|                                                            |   |   |
+------------------------------------------------------------+---+---+

**Name of CDC Employee Serving as Principal Investigator (PI) and
Degrees:**

+-------------------------------------------------------------------------+---+
| +-----------------------------------------------------------------+---+ |   |
| | +-------------------------------------------------------+---+   |   | |   |
| | | +---------------------------------------------+---+   |   |   |   | |   |
| | | | +-----------------------------------+---+   |   |   |   |   |   | |   |
| | | | | +-------------------------+---+   |   |   |   |   |   |   |   | |   |
| | | | | | +---------------+---+   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <table>       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td><p>9      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Check if PI   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | has           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | cha           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | nged</p></td> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <p><          |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | em>Scientific |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Ethics</em>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Verification  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | No.: <u>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </u></p></td> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <p>Telephone: |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <u> </u>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Fax: <u>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </u></p></td> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <p><strong>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | CIO</strong>: |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <u> </u>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <strong>Divis |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | ion</strong>: |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <u> </u>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <strong       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | >MS</strong>: |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <u>           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </u></p></td> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <p>Email      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Address:      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <u>           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </u></p></td> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <p>           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <strong>Names |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | of Other      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | CDC           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Employee      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Co-           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | investigators |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | (use          |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | supplemental  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | page if       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | &gt; than     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | 3):</str      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | ong></p></td> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <p>1. <u>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </u>          |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <             |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | em>Scientific |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Ethics</em>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Verification  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | No.: <u>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </u></p></td> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <p>2. <u>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </u>          |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <             |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | em>Scientific |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Ethics</em>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Verification  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | No.: <u>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </u></p></td> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <p>3. <u>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </u>          |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <             |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | em>Scientific |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Ethics</em>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Verification  |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | No.: <u>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </u></p></td> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <p>           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <strong><span |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="       |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | smallcaps">1. |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Funding</s    |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | pan></strong> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | (check        |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | one)</p></td> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <p><u> </u>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | PGO Funding   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Mechanism     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | U             |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | sed:</p></td> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <p><u> </u>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Cooperative   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Agreement     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | No(s).: <u>   |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </u></p></td> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | |               |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | [             |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | ]{.underline} |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | Contract      |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | No(s).: [     |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | | ]{.underline} |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | +---------------+---+   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | |               |   |   |   |   |   |   |   |   |   |   |   | |   |
| | | | | | +---------------+---+   |   |   |   |   |   |   |   |   |   | |   |
| | | | | |                         |   |   |   |   |   |   |   |   |   | |   |
| | | | | | [ ]{.underline} Grant:  |   |   |   |   |   |   |   |   |   | |   |
| | | | | | [ ]{.underline}         |   |   |   |   |   |   |   |   |   | |   |
| | | | | +-------------------------+---+   |   |   |   |   |   |   |   | |   |
| | | | | |                         |   |   |   |   |   |   |   |   |   | |   |
| | | | | +-------------------------+---+   |   |   |   |   |   |   |   | |   |
| | | | |                                   |   |   |   |   |   |   |   | |   |
| | | | | [ ]{.underline} Purchase Order    |   |   |   |   |   |   |   | |   |
| | | | | (a.k.a. Simplified Acquisition):  |   |   |   |   |   |   |   | |   |
| | | | | [ ]{.underline}                   |   |   |   |   |   |   |   | |   |
| | | | +-----------------------------------+---+   |   |   |   |   |   | |   |
| | | | |                                   |   |   |   |   |   |   |   | |   |
| | | | +-----------------------------------+---+   |   |   |   |   |   | |   |
| | | |                                             |   |   |   |   |   | |   |
| | | | [ ]{.underline} Other funding mechanism:    |   |   |   |   |   | |   |
| | | +---------------------------------------------+---+   |   |   |   | |   |
| | | |                                             |   |   |   |   |   | |   |
| | | +---------------------------------------------+---+   |   |   |   | |   |
| | |                                                       |   |   |   | |   |
| | | [ ]{.underline} Memorandum of Understanding (MOU)     |   |   |   | |   |
| | | (With whom): [ ]{.underline}                          |   |   |   | |   |
| | +-------------------------------------------------------+---+   |   | |   |
| | |                                                       |   |   |   | |   |
| | +-------------------------------------------------------+---+   |   | |   |
| |                                                                 |   | |   |
| | [ ]{.underline} Interagency Agreement (IAA) (Name of other      |   | |   |
| | agency): [ ]{.underline}                                        |   | |   |
| +-----------------------------------------------------------------+---+ |   |
| |                                                                 |   | |   |
| +-----------------------------------------------------------------+---+ |   |
|                                                                         |   |
| [ ]{.underline} Other (Specify type and with whom): [ ]{.underline}     |   |
+-------------------------------------------------------------------------+---+
|                                                                         |   |
+-------------------------------------------------------------------------+---+

[ ]{.underline} Only CDC investigators performing study

  -- --
     
     
  -- --

**2. Collaborating Sites **(Use additional sheets if necessary)

+-----------------------------------------------------------------+---+
| +-------------------------------------------------------+---+   |   |
| | +---------------------------------------------+---+   |   |   |   |
| | | +-----------------------------------+---+   |   |   |   |   |   |
| | | | +-------------------------+---+   |   |   |   |   |   |   |   |
| | | | | +---------------+---+   |   |   |   |   |   |   |   |   |   |
| | | | | | <table>       |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td><table>   |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tbody>       |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="odd">  |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td><p>2a.    |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | List any      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | collaborating |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | sites by      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | name and      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | location      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | (including    |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | state) that   |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | were added    |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | since last    |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | appro         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | val:</p></td> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <p><u> </u>   |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | None          |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | a             |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | dded</p></td> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <p            |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | ><strong>OPRR |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | Assurance     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | No.</str      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | ong></p></td> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <             |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | p>1.</p></td> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <             |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | p>2.</p></td> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <             |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | p>3.</p></td> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <             |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | p>4.</p></td> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <             |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | p>5.</p></td> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <p>2b. List   |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | any           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | collaborating |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | sites by      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | name and      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | location      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | (including    |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | state) that   |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | were          |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | deleted       |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | since last    |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | appro         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | val:</p></td> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <tr           |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | class="even"> |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | <td></td>     |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tr>         |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </tbody>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | </table>      |   |   |   |   |   |   |   |   |   |   |   |
| | | | | |               |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | [             |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | ]{.underline} |   |   |   |   |   |   |   |   |   |   |   |
| | | | | | None deleted  |   |   |   |   |   |   |   |   |   |   |   |
| | | | | +---------------+---+   |   |   |   |   |   |   |   |   |   |
| | | | | |               |   |   |   |   |   |   |   |   |   |   |   |
| | | | | +---------------+---+   |   |   |   |   |   |   |   |   |   |
| | | | |                         |   |   |   |   |   |   |   |   |   |
| | | | | 1\.                     |   |   |   |   |   |   |   |   |   |
| | | | +-------------------------+---+   |   |   |   |   |   |   |   |
| | | | |                         |   |   |   |   |   |   |   |   |   |
| | | | +-------------------------+---+   |   |   |   |   |   |   |   |
| | | |                                   |   |   |   |   |   |   |   |
| | | | 2\.                               |   |   |   |   |   |   |   |
| | | +-----------------------------------+---+   |   |   |   |   |   |
| | | |                                   |   |   |   |   |   |   |   |
| | | +-----------------------------------+---+   |   |   |   |   |   |
| | |                                             |   |   |   |   |   |
| | | 3\.                                         |   |   |   |   |   |
| | +---------------------------------------------+---+   |   |   |   |
| | |                                             |   |   |   |   |   |
| | +---------------------------------------------+---+   |   |   |   |
| |                                                       |   |   |   |
| | 4\.                                                   |   |   |   |
| +-------------------------------------------------------+---+   |   |
| |                                                       |   |   |   |
| +-------------------------------------------------------+---+   |   |
|                                                                 |   |
| 5\.                                                             |   |
+-----------------------------------------------------------------+---+
|                                                                 |   |
+-----------------------------------------------------------------+---+

**3. Description of proposed modification(s) to the protocol:**

  --
  --

**4. Reasons for proposed modification(s):**

+-------------------------------------------------------+
| +---------------------------------------------------+ |
| | +-----------------------------------------------+ | |
| | |   --                                          | | |
| | |   --                                          | | |
| | |                                               | | |
| | | **Approvals** (Signature and Position Title): | | |
| | +-----------------------------------------------+ | |
| |                                                   | |
| | **Date:**                                         | |
| +---------------------------------------------------+ |
|                                                       |
| **Remarks:**                                          |
+-------------------------------------------------------+
|                                                       |
+-------------------------------------------------------+

Branch Chief:

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Division Director:

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CIO Human Subjects Contact:

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