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<tbody>
<tr class="odd">
<td colspan="7" rowspan="4"><p><strong>DEPARTMENT OF HEALTH AND HUMAN
SERVICES</strong></p>
<p>FOOD AND DRUG ADMINISTRATION</p>
<p><em><strong>RADIOACTIVE DRUG RESEARCH COMMITTEE
(RDRC)</strong></em></p>
<p><strong>REPORT ON RESEARCH USE OF RADIOACTIVE DRUGS</strong></p>
<p><strong>MEMBERSHIP SUMMARY</strong></p></td>
<td colspan="5" rowspan="2"><p><em>Form Approved:</em></p>
<p><em>OMB No. 0910-0053.</em></p>
<p><em>Expiration Date: 2/29/08</em></p></td>
<td colspan="2"><strong>FOR FDA USE ONLY</strong></td>
</tr>
<tr class="even">
<td colspan="2" rowspan="3"></td>
</tr>
<tr class="odd">
<td colspan="5" rowspan="2"><p>DATE OF SUBMISSION</p>
<p>     </p></td>
</tr>
<tr class="even">
</tr>
<tr class="odd">
<td colspan="14"><strong>NOTE:</strong> 21 CFR361.1 Requires that an
annual report be submitted by each RDRC. Use Form FDA 2914 to report
names and qualifications of RDRC members and consultants. Also use Form
FDA 2915 to add special summaries, as required.</td>
</tr>
<tr class="even">
<td colspan="5" rowspan="2"><p><strong>Return COMPLETED form
to:</strong></p>
<blockquote>
<p>Food and Drug Administration<br />
Center for Drug Evaluation and Research Office of Oncology Drug
Products<br />
5901-B Ammendale Road<br />
Beltsville, MD 20705-1266</p>
<p>Attention: RDRC</p>
</blockquote></td>
<td colspan="5"><strong>Public reporting burden for this collection of
information</strong> is estimated to average 1 hour per response,
including the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing
reviewing the collection of information. Send comments regarding this
burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to the address on the
right.</td>
<td>►</td>
<td colspan="3"><blockquote>
<p>Food and Drug Administration</p>
<p>Center for Drug Evaluation and Research</p>
<p>Office of Oncology Drug Products<br />
5901-B Ammendale Road<br />
Beltsville, MD 20705-1266</p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="9"><blockquote>
<p><em>An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of</em></p>
<p><em>information unless it displays a currently valid OMB control
number.</em></p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="14"></td>
</tr>
<tr class="odd">
<td colspan="14"><blockquote>
<p><strong>A. GENERAL INFORMATION</strong></p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="4"><p>1. RDRC COMMITTEE NUMBER</p>
<blockquote>
<p>     </p>
</blockquote></td>
<td colspan="10"><blockquote>
<p>2. NAME OF INSTITUTION</p>
<p>     </p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="14"><blockquote>
<p>3. RDRC CHAIRPERSON</p>
</blockquote></td>
</tr>
<tr class="even">
<td></td>
<td colspan="7"><blockquote>
<p>a. Name</p>
<p>     </p>
</blockquote></td>
<td colspan="6"><blockquote>
<p>c. E-mail Address</p>
<p>     </p>
</blockquote></td>
</tr>
<tr class="odd">
<td rowspan="2"></td>
<td colspan="7" rowspan="2"><blockquote>
<p>b. Address <em>(Include ZIP code)</em></p>
<p>     </p>
</blockquote></td>
<td colspan="6"><blockquote>
<p>d. Telephone No. <em>(Include Area Code)</em></p>
<p>     </p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="6"><blockquote>
<p>e. Fax No. <em>(Include Area Code)</em></p>
<p>     </p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="14"></td>
</tr>
<tr class="even">
<td colspan="14"><blockquote>
<p><strong>B. REQUIRED MEMBERS</strong> <em>(Names and
Qualifications)</em></p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="14"><strong>NOTE: Names must be listed. Qualifications
previously submitted to FDA may be incorporated by reference to the
appropriate submission. An individual may not be listed in more than one
required specialty.</strong></td>
</tr>
<tr class="even">
<td colspan="14">1. PHYSICIAN(S) RECOGNIZED AS SPECIALIST(S) IN NUCLEAR
MEDICINE</td>
</tr>
<tr class="odd">
<td colspan="2" rowspan="5"></td>
<td colspan="4"><em><strong>Name</strong></em></td>
<td colspan="3"><em><strong>Are qualifications
attached?</strong></em></td>
<td colspan="4"><blockquote>
<p><em><strong>If No, enter date of most recently submitted curriculum
vitae</strong></em></p>
</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>a.</td>
<td colspan="3">     </td>
<td colspan="3"> Yes No</td>
<td colspan="4"><blockquote>
<p>     </p>
</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td>b.</td>
<td colspan="3">     </td>
<td colspan="3"> Yes No</td>
<td colspan="4"><blockquote>
<p>     </p>
</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>c.</td>
<td colspan="3">     </td>
<td colspan="3"> Yes No</td>
<td colspan="4"><blockquote>
<p>     </p>
</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="3"></td>
<td colspan="3"></td>
<td colspan="4"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="14">2. PERSON(S) QUALIFIED BY TRAINING AND EXPERIENCE TO
FORMULATE RADIOACTIVE DRUGS</td>
</tr>
<tr class="odd">
<td colspan="2" rowspan="5"></td>
<td colspan="4"><em><strong>Name</strong></em></td>
<td colspan="3"><em><strong>Are qualifications
attached?</strong></em></td>
<td colspan="4"><blockquote>
<p><em><strong>If No, enter date of most recently submitted curriculum
vitae</strong></em></p>
</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>a.</td>
<td colspan="3">     </td>
<td colspan="3"> Yes No</td>
<td colspan="4"><blockquote>
<p>     </p>
</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td>b.</td>
<td colspan="3">     </td>
<td colspan="3"> Yes No</td>
<td colspan="4"><blockquote>
<p>     </p>
</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>c.</td>
<td colspan="3">     </td>
<td colspan="3"> Yes No</td>
<td colspan="4"><blockquote>
<p>     </p>
</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="3"></td>
<td colspan="3"></td>
<td colspan="4"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="14">3. PERSON(S) WITH SPECIAL COMPETENCE IN RADIATION
DOSIMETRY</td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td colspan="4"><em><strong>Name</strong></em></td>
<td colspan="3"><em><strong>Are qualifications
attached?</strong></em></td>
<td colspan="4"><blockquote>
<p><em><strong>If No, enter date of most recently submitted curriculum
vitae</strong></em></p>
</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td>a.</td>
<td colspan="3">     </td>
<td colspan="3"> Yes No</td>
<td colspan="4"><blockquote>
<p>     </p>
</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td>b.</td>
<td colspan="3">     </td>
<td colspan="3"> Yes No</td>
<td colspan="4"><blockquote>
<p>     </p>
</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td>c.</td>
<td colspan="3">     </td>
<td colspan="3"> Yes No</td>
<td colspan="4"><blockquote>
<p>     </p>
</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td></td>
<td colspan="3"></td>
<td colspan="3"></td>
<td colspan="4"></td>
<td></td>
</tr>
</tbody>
</table>

+-----------------------------------------------------+----------------+
| > **C. OTHER VOTING MEMBERS** *(Names and           |                |
| > Disciplines; Specialties)*                        |                |
+-----------------------------------------------------+----------------+
|                                                     |                |
+-----------------------------------------------------+----------------+
| > **D. COMMITTEE CONSULTANTS** *(i.e.,              |                |
| > Pediatrician) (Names and Disciplines;             |                |
| > Specialties)*                                     |                |
+-----------------------------------------------------+----------------+
|                                                     |                |
+-----------------------------------------------------+----------------+
| > **E. NON-VOTING MEMBERS, IF ANY** *(Names and     |                |
| > Position Titles)*                                 |                |
+-----------------------------------------------------+----------------+
|                                                     |                |
+-----------------------------------------------------+----------------+
| > **F. STUDY SUMMARY TOTAL AND CHAIRPERSON          |                |
| > SIGNATURE**                                       |                |
+-----------------------------------------------------+----------------+
| 1\. NUMBER OF STUDY SUMMARIES SUBMITTED IN THIS     |                |
| REPORT                                              |                |
|                                                     |                |
| >                                                   |                |
+-----------------------------------------------------+----------------+
| 2\. SIGNATURE OF RDRC CHAIRPERSON                   | 3\. DATE       |
|                                                     |                |
|                                                     | >              |
+-----------------------------------------------------+----------------+
| **FOR FDA USE ONLY**                                |                |
+-----------------------------------------------------+----------------+
|                                                     |                |
+-----------------------------------------------------+----------------+

+-----------------------------------------------------------------------+
| **Instructions for Completing Radioactive Drug Research Committee     |
| (RDRC)\                                                               |
| Report on Research Use of Radioactive Drugs \--Membership Summary\    |
| (Form FDA 2914)**                                                     |
|                                                                       |
| > Basic research with radioactive drugs may be conducted without an   |
| > Investigational New Drug Application (IND) when the research is     |
| > conducted under a FDA-approved Radioactive Drug Research Committee  |
| > (RDRC) and other conditions, as specified in the RDRC regulations,  |
| > are met.                                                            |
| >                                                                     |
| > RDRC regulations are contained in Title 21, Code of Federal         |
| > Regulations, Part 361.1 (21 CFR 361.1) and maybe accessed at the    |
| > following web address:                                              |
| >                                                                     |
| > *http://www                                                         |
| .accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1* |
| >                                                                     |
| > Guidance regarding RDRC procedures is available from the FDA Center |
| > for Drug Evaluation and Research, Office of Oncology Drug Products, |
| > 5901-B Ammendale Road, Beltsville, MD 20705-1266. Information about |
| > the FDA RDRC program is available at the RDRC web site at the       |
| > following web address:\                                             |
| > *http://www.fda.gov/cder/regulatory/RDRC/default.htm*               |
| >                                                                     |
| > Access to RDRC reporting Forms (2914 -Membership Summary and 2915   |
| > -Study Summary) in both Adobe Acrobat and Microsoft Word versions,  |
| > which can be filled out and saved on your computer, can be obtained |
| > through the RDRC web site or from the following FDA Forms website:\ |
| > *http://www.fda.gov/opacom/morechoices/fdaforms/default.html*       |
| >                                                                     |
| > The following instructions address only the administrative aspects  |
| > of preparing and submitting Form FDA 2914 (Membership Summary) for  |
| > the following RDRC submissions:                                     |
|                                                                       |
| 1.  **Original Application** (21 CFR 361.1 (c)(4)\                    |
|     Approval)An application for FDA approval of RDRC consists of      |
|     submission of Form FDA 2914 (Membership Summary), current and     |
|     dated curriculum vitae for each proposed committee member, and    |
|     statement that the RDRC agrees to comply with the requirements    |
|     under 21 CFR 361.1.                                               |
|                                                                       |
| 2.  **Annual Report** (requirement -- 21 CFR 361.1 (c)(3) Reports)\   |
|     The annual report, due on or before January 31 of each year,      |
|     consists of submission of Form FDA 2914\                          |
|     (Membership Summary) and Form FDA 2915 (Study Summary) for each   |
|     study conducted during the\                                       |
|     preceding calendar year. A Form FDA 2915 (Study Summary) should   |
|     be submitted even for studies that did\                           |
|     not enroll any subjects in the preceding calendar year but have   |
|     been previously approved by the RDRC and\                         |
|     are still open and ongoing.                                       |
|                                                                       |
| 3.  **Membership Changes** (21 CFR 361.1 (c)(4) Approval)\            |
|     Changes in membership and applications for new members must be    |
|     submitted as soon as, or before, vacancies\                       |
|     occur on the committee and consists of submission of Form FDA     |
|     2914 (Membership Summary) and current\                            |
|     and dated curriculum vitae for each proposed new committee        |
|     member. The submitted Form FDA 2914\                              |
|     Membership Summary should include the names of all members of the |
|     RDRC.                                                             |
|                                                                       |
| > **WHERE TO SEND THE SUBMISSION:** Food and Drug Administration\     |
| > Center for Drug Evaluation and Research\                            |
| > Office of Oncology Drug Products\                                   |
| > 5901-B Ammendale Road\                                              |
| > Beltsville, MD 20705-1266                                           |
| >                                                                     |
| > ATTN: RDRC                                                          |
| >                                                                     |
| > *Specific instructions for filling out this report are on the next  |
| > page.*                                                              |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| #### FILLING OUT FORM FDA 2914                                        |
|                                                                       |
| > *(Titles and numbers, when used, correspond to the item blocks on   |
| > Form FDA 2914)*                                                     |
| >                                                                     |
| > **Section A. General Information**                                  |
|                                                                       |
| 1.  **RDRC Committee Number \--** Provide the committee number        |
|     assigned by FDA when the RDRC was initially approved. Leave blank |
|     for original applications.                                        |
|                                                                       |
| 2.  **Name of Institution --** Provide the name of the medical        |
|     institution to which the RDRC is affiliated. For annual reports   |
|     and membership changes, if the name of the medical institution is |
|     different from that provided in the previous submission, please   |
|     attach a cover letter specifying the old and new names.           |
|                                                                       |
| 3.  **RDRC Chairperson**                                              |
|                                                                       |
| > a\. NAME Provide the name of the chairperson of the RDRC.           |
| >                                                                     |
| > b\. ADDRESS Provide the address to which written correspondence     |
| > from FDA should be                                                  |
| >                                                                     |
| > directed. If this address is a post office box number, a street     |
| > address must also\                                                  |
| > be provided.                                                        |
| >                                                                     |
| > c\. E-MAIL Provide the e-mail address of the RDRC chairperson to    |
| > which electronic                                                    |
| >                                                                     |
| > correspondences from FDA should be directed.                        |
| >                                                                     |
| > d\. TELEPHONE NO Provide the telephone number where the RDRC        |
| > chairperson is usually available                                    |
| >                                                                     |
| > during normal working hours. A telephone number must be provided.   |
| >                                                                     |
| > e\. FAX NO Provide the fax number of the RDRC chairperson to which  |
| > facsimile                                                           |
| >                                                                     |
| > correspondences from FDA should be directed.                        |
| >                                                                     |
| > ***MEMBERSHIP**---For original applications and annual reports an*d |
| > *membershi*p *changes*, *fill in sections B. through E. referenced  |
| > below.*                                                             |
| >                                                                     |
| > **Section B. Required Members** -- Provide the names and            |
| > qualifications of each required member:                             |
| >                                                                     |
| > 1\. Physician recognized as a specialist in nuclear medicine        |
| >                                                                     |
| > 2\. Person qualified by training and experience to formulate        |
| > radioactive drugs                                                   |
| >                                                                     |
| > 3\. Person with special competence in radiation safety and          |
| > radiation dosimetry                                                 |
| >                                                                     |
| > If there are more than three members in a required specialty,       |
| > attach a separate sheet.                                            |
| >                                                                     |
| > Attach a current and dated curriculum vitae describing relevant     |
| > degrees, training, and experience for each\                         |
| > required member. If this is an annual report and qualifications     |
| > have been previously submitted to FDA,\                             |
| > provide the date of the most recent previous submission for each    |
| > listed member.                                                      |
| >                                                                     |
| > **Section C. Other Voting Members** \-- Provide the names,          |
| > disciplines, and specialties of other committee\                    |
| > members.                                                            |
| >                                                                     |
| > Attach current and dated curriculum vitae for each other voting     |
| > member. If this is an annual report and qualifications have been    |
| > previously submitted to FDA, provide the date of the most recent    |
| > previous submission for each listed member.                         |
| >                                                                     |
| > **Section D. Committee Consultants** \-- Provide the names,         |
| > disciplines, and specialties of committee consultants. Provide a    |
| > current and dated CV for each consultant used by the committee      |
| > during the annual report cycle.                                     |
| >                                                                     |
| > **Section E. Non-Voting Members, if any** \-- Provide the names and |
| > position titles of non-voting committee\                            |
| > members.                                                            |
| >                                                                     |
| > **Section F. Study Summary Total and Chairperson Signature**        |
|                                                                       |
| 1.  *Number of Study Summaries Submitted in This Report* \-- For      |
|     annual reports, provide the number of\                            |
|     Study Summaries included in the submission. For original          |
|     applications and membership changes, leave blank.                 |
|                                                                       |
| 2.  *Signature of the RDRC Chairperson* \-- The RDRC chairperson must |
|     sign the form.                                                    |
|                                                                       |
| 3.  *Date* \-- Indicate the date the form is signed by the RDRC       |
|     chairperson.                                                      |
+-----------------------------------------------------------------------+