+---------------------------------------------+------------------------+
| # DEPARTMENT OF HEALTH AND HUMAN SERVICES   | Form Approved: OMB No. |
|                                             | 0910-0014.             |
| FOOD AND DRUG ADMINISTRATION                |                        |
|                                             | Expiration Date: May   |
| ## STATEMENT OF INVESTIGATOR                | 31, 2009.              |
|                                             |                        |
| ***(TITLE 21, CODE OF FEDERAL REGULATIONS   | *See OMB Statement on  |
| (CFR) PART 312)***                          | Reverse.*              |
|                                             |                        |
| (See instructions on reverse side.)         |                        |
+---------------------------------------------+------------------------+
|                                             | **NOTE:** No           |
|                                             | investigator may       |
|                                             | participate in an      |
|                                             | investigation until    |
|                                             | he/she provides the    |
|                                             | sponsor with a         |
|                                             | completed, signed      |
|                                             | Statement of           |
|                                             | Investigator, Form FDA |
|                                             | 1572 (21 CFR           |
|                                             | 312.53(c)).            |
+---------------------------------------------+------------------------+
| 1\. NAME AND ADDRESS OF INVESTIGATOR        |                        |
+---------------------------------------------+------------------------+
| >                                           |                        |
+---------------------------------------------+------------------------+
| 2\. EDUCATION, TRAINING, AND EXPERIENCE     |                        |
| THAT QUALIFIES THE INVESTIGATOR AS AN       |                        |
| EXPERT IN THE CLINICAL INVESTIGATION OF THE |                        |
| DRUG FOR THE USE UNDER INVESTIGATION. ONE   |                        |
| OF THE FOLLOWING IS ATTACHED.               |                        |
+---------------------------------------------+------------------------+
| CURRICULUM VITAE OTHER STATEMENT OF         |                        |
| QUALIFICATIONS                              |                        |
+---------------------------------------------+------------------------+
| 3\. NAME AND ADDRESS OF ANY MEDICAL SCHOOL, |                        |
| HOSPITAL OR OTHER RESEARCH FACILITY WHERE   |                        |
| THE CLINICAL INVESTIGATION(S) WILL BE       |                        |
| CONDUCTED.                                  |                        |
+---------------------------------------------+------------------------+
| >                                           |                        |
+---------------------------------------------+------------------------+
| 4\. NAME AND ADDRESS OF ANY CLINICAL        |                        |
| LABORATORY FACILITIES TO BE USED IN THE     |                        |
| STUDY.                                      |                        |
+---------------------------------------------+------------------------+
| >                                           |                        |
+---------------------------------------------+------------------------+
| 5\. NAME AND ADDRESS OF THE INSTITUTIONAL   |                        |
| REVIEW BOARD (IRB) THAT IS RESPONSIBLE FOR  |                        |
| REVIEW AND APPROVAL OF THE STUDY(IES).      |                        |
+---------------------------------------------+------------------------+
| >                                           |                        |
+---------------------------------------------+------------------------+
| 6\. NAMES OF THE SUBINVESTIGATORS *(e.g.,   |                        |
| research fellows, residents, associates)*   |                        |
| WHO WILL BE ASSISTING THE INVESTIGATOR IN   |                        |
| THE CONDUCT OF THE INVESTIGATION(S).        |                        |
+---------------------------------------------+------------------------+
| >                                           |                        |
+---------------------------------------------+------------------------+
| 7\. NAME AND CODE NUMBER, IF ANY, OF THE    |                        |
| PROTOCOL(S) IN THE IND FOR THE STUDY(IES)   |                        |
| TO BE CONDUCTED BY THE INVESTIGATOR.        |                        |
+---------------------------------------------+------------------------+
| >                                           |                        |
+---------------------------------------------+------------------------+

+---------------------+---------------------------+---+----------------+
| 8\. ATTACH THE      |                           |   |                |
| FOLLOWING CLINICAL  |                           |   |                |
| PROTOCOL            |                           |   |                |
| INFORMATION:        |                           |   |                |
|                     |                           |   |                |
| FOR PHASE 1         |                           |   |                |
| INVESTIGATIONS, A   |                           |   |                |
| GENERAL OUTLINE OF  |                           |   |                |
| THE PLANNED         |                           |   |                |
| INVESTIGATION       |                           |   |                |
| INCLUDING THE       |                           |   |                |
| ESTIMATED DURATION  |                           |   |                |
| OF\                 |                           |   |                |
| THE STUDY AND THE   |                           |   |                |
| MAXIMUM NUMBER OF   |                           |   |                |
| SUBJECTS THAT WILL  |                           |   |                |
| BE INVOLVED.        |                           |   |                |
|                     |                           |   |                |
| FOR PHASE 2 OR 3    |                           |   |                |
| INVESTIGATIONS, AN  |                           |   |                |
| OUTLINE OF THE      |                           |   |                |
| STUDY PROTOCOL      |                           |   |                |
| INCLUDING AN        |                           |   |                |
| APPROXIMATION OF    |                           |   |                |
| THE NUMBER OF       |                           |   |                |
| SUBJECTS TO BE      |                           |   |                |
| TREATED WITH THE    |                           |   |                |
| DRUG AND THE NUMBER |                           |   |                |
| TO BE EMPLOYED AS   |                           |   |                |
| CONTROLS, IF ANY;   |                           |   |                |
| THE CLINICAL USES   |                           |   |                |
| TO BE INVESTIGATED; |                           |   |                |
| CHARACTERISTICS OF  |                           |   |                |
| SUBJECTS BY AGE,    |                           |   |                |
| SEX, AND CONDITION; |                           |   |                |
| THE KIND OF         |                           |   |                |
| CLINICAL            |                           |   |                |
| OBSERVATIONS AND    |                           |   |                |
| LABORATORY TESTS TO |                           |   |                |
| BE CONDUCTED; THE   |                           |   |                |
| ESTIMATED DURATION  |                           |   |                |
| OF THE STUDY; AND   |                           |   |                |
| COPIES OR A         |                           |   |                |
| DESCRIPTION OF CASE |                           |   |                |
| REPORT FORMS TO BE  |                           |   |                |
| USED.               |                           |   |                |
+---------------------+---------------------------+---+----------------+
| 9\. COMMITMENTS:    |                           |   |                |
|                     |                           |   |                |
| > I agree to        |                           |   |                |
| > conduct the       |                           |   |                |
| > study(ies) in     |                           |   |                |
| > accordance with   |                           |   |                |
| > the relevant,     |                           |   |                |
| > current           |                           |   |                |
| > protocol(s) and   |                           |   |                |
| > will only make    |                           |   |                |
| > changes in a      |                           |   |                |
| > protocol after    |                           |   |                |
| > notifying\        |                           |   |                |
| > the sponsor,      |                           |   |                |
| > except when       |                           |   |                |
| > necessary to      |                           |   |                |
| > protect the       |                           |   |                |
| > safety, rights,   |                           |   |                |
| > or welfare of     |                           |   |                |
| > subjects.         |                           |   |                |
| >                   |                           |   |                |
| > I agree to        |                           |   |                |
| > personally        |                           |   |                |
| > conduct or        |                           |   |                |
| > supervise the     |                           |   |                |
| > described         |                           |   |                |
| > investigation(s). |                           |   |                |
| >                   |                           |   |                |
| > I agree to inform |                           |   |                |
| > any patients, or  |                           |   |                |
| > any persons used  |                           |   |                |
| > as controls, that |                           |   |                |
| > the drugs are     |                           |   |                |
| > being used for    |                           |   |                |
| > investigational   |                           |   |                |
| > purposes and I    |                           |   |                |
| > will ensure\      |                           |   |                |
| > that the          |                           |   |                |
| > requirements      |                           |   |                |
| > relating to       |                           |   |                |
| > obtaining         |                           |   |                |
| > informed consent  |                           |   |                |
| > in 21 CFR Part 50 |                           |   |                |
| > and institutional |                           |   |                |
| > review board      |                           |   |                |
| > (IRB) review and  |                           |   |                |
| > approval in 21    |                           |   |                |
| > CFR Part 56 are   |                           |   |                |
| > met.              |                           |   |                |
| >                   |                           |   |                |
| > I agree to report |                           |   |                |
| > to the sponsor    |                           |   |                |
| > adverse           |                           |   |                |
| > experiences that  |                           |   |                |
| > occur in the      |                           |   |                |
| > course of the     |                           |   |                |
| > investigation(s)  |                           |   |                |
| > in accordance     |                           |   |                |
| > with 21 CFR       |                           |   |                |
| > 312.64.           |                           |   |                |
| >                   |                           |   |                |
| > I have read and   |                           |   |                |
| > understand the    |                           |   |                |
| > information in    |                           |   |                |
| > the               |                           |   |                |
| > investigator's    |                           |   |                |
| > brochure,         |                           |   |                |
| > including the     |                           |   |                |
| > potential risks   |                           |   |                |
| > and side effects  |                           |   |                |
| > of the drug.      |                           |   |                |
| >                   |                           |   |                |
| > I agree to ensure |                           |   |                |
| > that all          |                           |   |                |
| > associates,       |                           |   |                |
| > colleagues, and   |                           |   |                |
| > employees         |                           |   |                |
| > assisting in the  |                           |   |                |
| > conduct of the    |                           |   |                |
| > study(ies) are    |                           |   |                |
| > informed about    |                           |   |                |
| > their             |                           |   |                |
| > obligations\      |                           |   |                |
| > in meeting the    |                           |   |                |
| > above             |                           |   |                |
| > commitments.      |                           |   |                |
| >                   |                           |   |                |
| > I agree to        |                           |   |                |
| > maintain adequate |                           |   |                |
| > and accurate      |                           |   |                |
| > records in        |                           |   |                |
| > accordance with   |                           |   |                |
| > 21 CFR 312.62 and |                           |   |                |
| > to make those     |                           |   |                |
| > records available |                           |   |                |
| > for inspection in |                           |   |                |
| > accordance with   |                           |   |                |
| > 21 CFR 312.68.    |                           |   |                |
| >                   |                           |   |                |
| > I will ensure     |                           |   |                |
| > that an IRB that  |                           |   |                |
| > complies with the |                           |   |                |
| > requirements of   |                           |   |                |
| > 21 CFR Part 56    |                           |   |                |
| > will be           |                           |   |                |
| > responsible for   |                           |   |                |
| > the initial and   |                           |   |                |
| > continuing review |                           |   |                |
| > and approval of   |                           |   |                |
| > the clinical      |                           |   |                |
| > investigation. I  |                           |   |                |
| > also agree to     |                           |   |                |
| > promptly report   |                           |   |                |
| > to the IRB all    |                           |   |                |
| > changes in the    |                           |   |                |
| > research activity |                           |   |                |
| > and all           |                           |   |                |
| > unanticipated\    |                           |   |                |
| > problems          |                           |   |                |
| > involving risks   |                           |   |                |
| > to human subjects |                           |   |                |
| > or others.        |                           |   |                |
| > Additionally, I   |                           |   |                |
| > will not make any |                           |   |                |
| > changes in the    |                           |   |                |
| > research without  |                           |   |                |
| > IRB approval,     |                           |   |                |
| > except where      |                           |   |                |
| > necessary to      |                           |   |                |
| > eliminate         |                           |   |                |
| > apparent          |                           |   |                |
| > immediate hazards |                           |   |                |
| > to human          |                           |   |                |
| > subjects.         |                           |   |                |
| >                   |                           |   |                |
| > I agree to comply |                           |   |                |
| > with all other    |                           |   |                |
| > requirements      |                           |   |                |
| > regarding the     |                           |   |                |
| > obligations of    |                           |   |                |
| > clinical          |                           |   |                |
| > investigators and |                           |   |                |
| > all other         |                           |   |                |
| > pertinent         |                           |   |                |
| > requirements in   |                           |   |                |
| > 21 CFR\           |                           |   |                |
| > Part 312.         |                           |   |                |
+---------------------+---------------------------+---+----------------+
| **INSTRUCTIONS FOR  |                           |   |                |
| COMPLETING FORM FDA |                           |   |                |
| 1572\               |                           |   |                |
| STATEMENT OF        |                           |   |                |
| INVESTIGATOR:**     |                           |   |                |
|                     |                           |   |                |
| > 1\. Complete all  |                           |   |                |
| > sections. Attach  |                           |   |                |
| > a separate page   |                           |   |                |
| > if additional     |                           |   |                |
| > space is needed.  |                           |   |                |
| >                   |                           |   |                |
| > 2\. Attach        |                           |   |                |
| > curriculum vitae  |                           |   |                |
| > or other          |                           |   |                |
| > statement of      |                           |   |                |
| > qualifications as |                           |   |                |
| > described in      |                           |   |                |
| > Section 2.        |                           |   |                |
| >                   |                           |   |                |
| > 3\. Attach        |                           |   |                |
| > protocol outline  |                           |   |                |
| > as described in   |                           |   |                |
| > Section 8.        |                           |   |                |
| >                   |                           |   |                |
| > 4\. Sign and date |                           |   |                |
| > below.            |                           |   |                |
| >                   |                           |   |                |
| > 5\. FORWARD THE   |                           |   |                |
| > COMPLETED FORM    |                           |   |                |
| > AND ATTACHMENTS   |                           |   |                |
| > TO THE SPONSOR.   |                           |   |                |
| > The sponsor will  |                           |   |                |
| > incorporate this  |                           |   |                |
| > information along |                           |   |                |
| > with other        |                           |   |                |
| > technical data    |                           |   |                |
| > into an           |                           |   |                |
| > Investigational   |                           |   |                |
| > New Drug          |                           |   |                |
| > Application       |                           |   |                |
| > (IND).\           |                           |   |                |
| > INVESTIGATORS     |                           |   |                |
| > SHOULD NOT SEND   |                           |   |                |
| > THIS FORM         |                           |   |                |
| > DIRECTLY TO THE   |                           |   |                |
| > FOOD AND DRUG     |                           |   |                |
| > ADMINISTRATION.   |                           |   |                |
+---------------------+---------------------------+---+----------------+
| 10\. SIGNATURE OF   |                           |   | 11\. DATE      |
| INVESTIGATOR        |                           |   |                |
+---------------------+---------------------------+---+----------------+
|                     |                           |   | >              |
+---------------------+---------------------------+---+----------------+
| (**WARNING:** A     |                           |   |                |
| willfully false     |                           |   |                |
| statement is a      |                           |   |                |
| criminal offense.   |                           |   |                |
| U.S.C. Title 18,    |                           |   |                |
| Sec. 1001.)         |                           |   |                |
+---------------------+---------------------------+---+----------------+
| Public reporting    |                           |   |                |
| burden for this     |                           |   |                |
| collection of       |                           |   |                |
| information is      |                           |   |                |
| estimated to        |                           |   |                |
| average 100 hours   |                           |   |                |
| 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:          |                           |   |                |
+---------------------+---------------------------+---+----------------+
| Department of       | Department of Health and  | \ |                |
| Health and Human    | Human Services            | " |                |
| Services            |                           | A |                |
|                     | Food and Drug             | n |                |
| Food and Drug       | Administration            | a |                |
| Administration      |                           | g |                |
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| Evaluation and      | (HFM-99)                  | c |                |
| Research            |                           | y |                |
|                     | 1401 Rockville Pike       | m |                |
| Central Document    |                           | a |                |
| Room                | Rockville, MD 20852-1448  | y |                |
|                     |                           | n |                |
| 5901-B Ammendale    |                           | o |                |
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+---------------------+---------------------------+---+----------------+
| **Please DO NOT     |                           |   |                |
| RETURN this         |                           |   |                |
| application to this |                           |   |                |
| address.**          |                           |   |                |
+---------------------+---------------------------+---+----------------+