+---+-------------------+---+------------+--------+---+---+---+----------------+
| # |                   |   |            | *Form  |   |   |   | ## FO          |
| # |                   |   |            | Appr   |   |   |   | R FDA USE ONLY |
|   |                   |   |            | oved:\ |   |   |   |                |
| D |                   |   |            | OMB    |   |   |   |                |
| E |                   |   |            | No.    |   |   |   |                |
| P |                   |   |            | 0910-  |   |   |   |                |
| A |                   |   |            | 0053.* |   |   |   |                |
| R |                   |   |            |        |   |   |   |                |
| T |                   |   |            | *Expi  |   |   |   |                |
| M |                   |   |            | ration |   |   |   |                |
| E |                   |   |            | Date:  |   |   |   |                |
| N |                   |   |            | 2/     |   |   |   |                |
| T |                   |   |            | 29/08* |   |   |   |                |
|   |                   |   |            |        |   |   |   |                |
| O |                   |   |            |        |   |   |   |                |
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+---+-------------------+---+------------+--------+---+---+---+----------------+
|   |                   |   |            |        |   |   |   |                |
+---+-------------------+---+------------+--------+---+---+---+----------------+
|   |                   |   |            | DATE   |   |   |   |                |
|   |                   |   |            | OF     |   |   |   |                |
|   |                   |   |            | SUBM   |   |   |   |                |
|   |                   |   |            | ISSION |   |   |   |                |
|   |                   |   |            |        |   |   |   |                |
|   |                   |   |            |        |   |   |   |                |
+---+-------------------+---+------------+--------+---+---+---+----------------+
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+---+-------------------+---+------------+--------+---+---+---+----------------+
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
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+---+-------------------+---+------------+--------+---+---+---+----------------+
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+---+-------------------+---+------------+--------+---+---+---+----------------+
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+---+-------------------+---+------------+--------+---+---+---+----------------+
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|   |                   |   |            |        |   |   |   |                |
+---+-------------------+---+------------+--------+---+---+---+----------------+
|   |                   |   |            |        |   |   |   |                |
+---+-------------------+---+------------+--------+---+---+---+----------------+
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
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| P |                   |   |            |        |   |   |   |                |
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| C |                   |   |            |        |   |   |   |                |
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| F |                   |   |            |        |   |   |   |                |
| I |                   |   |            |        |   |   |   |                |
| C |                   |   |            |        |   |   |   |                |
|   |                   |   |            |        |   |   |   |                |
| I |                   |   |            |        |   |   |   |                |
| N |                   |   |            |        |   |   |   |                |
| F |                   |   |            |        |   |   |   |                |
| O |                   |   |            |        |   |   |   |                |
| R |                   |   |            |        |   |   |   |                |
| M |                   |   |            |        |   |   |   |                |
| A |                   |   |            |        |   |   |   |                |
| T |                   |   |            |        |   |   |   |                |
| I |                   |   |            |        |   |   |   |                |
| O |                   |   |            |        |   |   |   |                |
| N |                   |   |            |        |   |   |   |                |
+---+-------------------+---+------------+--------+---+---+---+----------------+
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
|   |                   |   |            |        |   |   |   |                |
| 1 |                   |   |            |        |   |   |   |                |
| . |                   |   |            |        |   |   |   |                |
|   |                   |   |            |        |   |   |   |                |
| R |                   |   |            |        |   |   |   |                |
| E |                   |   |            |        |   |   |   |                |
| S |                   |   |            |        |   |   |   |                |
| E |                   |   |            |        |   |   |   |                |
| A |                   |   |            |        |   |   |   |                |
| R |                   |   |            |        |   |   |   |                |
| C |                   |   |            |        |   |   |   |                |
| H |                   |   |            |        |   |   |   |                |
|   |                   |   |            |        |   |   |   |                |
| P |                   |   |            |        |   |   |   |                |
| R |                   |   |            |        |   |   |   |                |
| O |                   |   |            |        |   |   |   |                |
| J |                   |   |            |        |   |   |   |                |
| E |                   |   |            |        |   |   |   |                |
| C |                   |   |            |        |   |   |   |                |
| T |                   |   |            |        |   |   |   |                |
+---+-------------------+---+------------+--------+---+---+---+----------------+
| # | #                 |   |            |        |   |   |   |                |
| # | ######## Title of |   |            |        |   |   |   |                |
| # |  Research Project |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # | >                 |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
| # |                   |   |            |        |   |   |   |                |
|   |                   |   |            |        |   |   |   |                |
+---+-------------------+---+------------+--------+---+---+---+----------------+
| # | ######### b       |   | #          |        | # |   |   |                |
| # | . Study ID Number |   | ######## c |        | # |   |   |                |
| # |                   |   | . Original |        | # |   |   |                |
| # | >                 |   |  Study App |        | # |   |   |                |
| # |                   |   | roval Date |        | # |   |   |                |
| # |                   |   |            |        | # |   |   |                |
| # |                   |   | >          |        | # |   |   |                |
| # |                   |   |            |        | # |   |   |                |
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+---+-------------------+---+------------+--------+---+---+---+----------------+
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| . |                   |   |            |        |   |   |   |                |
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+---+-------------------+---+------------+--------+---+---+---+----------------+
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| ) |                   |   |            |        |   |   |   |                |
| * |                   |   |            |        |   |   |   |                |
| > |                   |   |            |        |   |   |   |                |
| > |                   |   |            |        |   |   |   |                |
|   |                   |   |            |        |   |   |   |                |
|   |                   |   |            |        |   |   |   |                |
|   |                   |   |            |        |   |   |   |                |
|   |                   |   |            |        |   |   |   |                |
|   |                   |   |            |        |   |   |   |                |
|   |                   |   |            |        |   |   |   |                |
+---+-------------------+---+------------+--------+---+---+---+----------------+

+---------+---+------------+--------+-----------+----------------------+
| **B.    |   |            |        |           |                      |
| S       |   |            |        |           |                      |
| PECIFIC |   |            |        |           |                      |
| INFO    |   |            |        |           |                      |
| RMATION |   |            |        |           |                      |
| *       |   |            |        |           |                      |
| (Contin |   |            |        |           |                      |
| ued)*** |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| 4\.     |   |            |        |           |                      |
| P       |   |            |        |           |                      |
| HARMACO |   |            |        |           |                      |
| LOGICAL |   |            |        |           |                      |
| DOSE    |   |            |        |           |                      |
| (Based  |   |            |        |           |                      |
| on      |   |            |        |           |                      |
| p       |   |            |        |           |                      |
| harmaco |   |            |        |           |                      |
| logical |   |            |        |           |                      |
| data    |   |            |        |           |                      |
| av      |   |            |        |           |                      |
| ailable |   |            |        |           |                      |
| from    |   |            |        |           |                      |
| studies |   |            |        |           |                      |
| in      |   |            |        |           |                      |
| *human* |   |            |        |           |                      |
| su      |   |            |        |           |                      |
| bjects, |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| dose    |   |            |        |           |                      |
| should  |   |            |        |           |                      |
| be      |   |            |        |           |                      |
| known   |   |            |        |           |                      |
| not to\ |   |            |        |           |                      |
| cause   |   |            |        |           |                      |
| any     |   |            |        |           |                      |
| cli     |   |            |        |           |                      |
| nically |   |            |        |           |                      |
| det     |   |            |        |           |                      |
| ectable |   |            |        |           |                      |
| p       |   |            |        |           |                      |
| harmaco |   |            |        |           |                      |
| logical |   |            |        |           |                      |
| effect  |   |            |        |           |                      |
| in      |   |            |        |           |                      |
| human   |   |            |        |           |                      |
| b       |   |            |        |           |                      |
| eings.) |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **Study |   |            |        |           |                      |
| Drug    |   |            |        |           |                      |
| #1**    |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **      |   |            |        |           |                      |
| Provide |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| Refer   |   |            |        |           |                      |
| ence**, |   |            |        |           |                      |
| s       |   |            |        |           |                      |
| upplied |   |            |        |           |                      |
| by the  |   |            |        |           |                      |
| inves   |   |            |        |           |                      |
| tigator |   |            |        |           |                      |
| and/or  |   |            |        |           |                      |
| used by |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| RDRC,   |   |            |        |           |                      |
| to show |   |            |        |           |                      |
| that    |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| amount  |   |            |        |           |                      |
| of      |   |            |        |           |                      |
| active  |   |            |        |           |                      |
| ing     |   |            |        |           |                      |
| redient |   |            |        |           |                      |
| or      |   |            |        |           |                      |
| comb    |   |            |        |           |                      |
| ination |   |            |        |           |                      |
| of      |   |            |        |           |                      |
| active  |   |            |        |           |                      |
|         |   |            |        |           |                      |
| ingr    |   |            |        |           |                      |
| edients |   |            |        |           |                      |
| to be   |   |            |        |           |                      |
| admin   |   |            |        |           |                      |
| istered |   |            |        |           |                      |
| shall   |   |            |        |           |                      |
| be      |   |            |        |           |                      |
| known   |   |            |        |           |                      |
| not to  |   |            |        |           |                      |
| cause   |   |            |        |           |                      |
| any     |   |            |        |           |                      |
| cli     |   |            |        |           |                      |
| nically |   |            |        |           |                      |
| det     |   |            |        |           |                      |
| ectable |   |            |        |           |                      |
| p       |   |            |        |           |                      |
| harmaco |   |            |        |           |                      |
| logical |   |            |        |           |                      |
| effect  |   |            |        |           |                      |
| in      |   |            |        |           |                      |
| human   |   |            |        |           |                      |
| beings, |   |            |        |           |                      |
| based   |   |            |        |           |                      |
| on      |   |            |        |           |                      |
|         |   |            |        |           |                      |
| p       |   |            |        |           |                      |
| harmaco |   |            |        |           |                      |
| logical |   |            |        |           |                      |
| dose    |   |            |        |           |                      |
| calcu   |   |            |        |           |                      |
| lations |   |            |        |           |                      |
| on data |   |            |        |           |                      |
| av      |   |            |        |           |                      |
| ailable |   |            |        |           |                      |
| from    |   |            |        |           |                      |
| pu      |   |            |        |           |                      |
| blished |   |            |        |           |                      |
| lit     |   |            |        |           |                      |
| erature |   |            |        |           |                      |
| or from |   |            |        |           |                      |
| other   |   |            |        |           |                      |
| valid   |   |            |        |           |                      |
| human   |   |            |        |           |                      |
| studies |   |            |        |           |                      |
| \[21    |   |            |        |           |                      |
| CFR     |   |            |        |           |                      |
| 361.1   |   |            |        |           |                      |
| (b)(2)  |   |            |        |           |                      |
| and     |   |            |        |           |                      |
| (d      |   |            |        |           |                      |
| )(2)\]. |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **      |   |            |        |           |                      |
|      ** |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| \(a\)   |   |            |        |           |                      |
| Name of |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| **no    |   |            |        |           |                      |
| nradioa |   |            |        |           |                      |
| ctive** |   |            |        |           |                      |
| drug    |   |            |        |           |                      |
|         |   |            |        |           |                      |
| > **    |   |            |        |           |                      |
|      ** |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| \(b\)   |   |            |        |           |                      |
| Mass    |   |            |        |           |                      |
| dose    |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| > (b.1) |   |            |        | (b.2)     |                      |
| >       |   |            |        | No-obs    |                      |
| Maximum |   |            |        | erved-eff |                      |
| > mass  |   |            |        | ect-level |                      |
| > dose  |   |            |        | (NOEL)    |                      |
| >       |   |            |        | mass dose |                      |
| (i.e.µ, |   |            |        |           |                      |
| > g or  |   |            |        | >         |                      |
| > mg)   |   |            |        |           |                      |
| > of    |   |            |        |           |                      |
| >       |   |            |        |           |                      |
|  ***non |   |            |        |           |                      |
| radioac |   |            |        |           |                      |
| tive*** |   |            |        |           |                      |
| > drug  |   |            |        |           |                      |
| > admin |   |            |        |           |                      |
| istered |   |            |        |           |                      |
| > per   |   |            |        |           |                      |
| > s     |   |            |        |           |                      |
| ubject, |   |            |        |           |                      |
| > per   |   |            |        |           |                      |
| >       |   |            |        |           |                      |
|  single |   |            |        |           |                      |
| > dose  |   |            |        |           |                      |
| >       |   |            |        |           |                      |
| >       |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| > c\.   |   |            | \(d\)  |           | \(e\) If the radio   |
| >       |   |            | Route  |           | active drug or       |
|  Number |   |            | of     |           | nonradioactive drug  |
| > of    |   |            | adm    |           | is under an IND,     |
| > doses |   |            | inistr |           | list IND Number.     |
| > per   |   |            | ation\ |           |                      |
| > s     |   |            | (i.e., |           | >                    |
| ubject. |   |            | I.V.,  |           |                      |
|         |   |            | P.O.,  |           |                      |
|         |   |            | etc.)  |           |                      |
|         |   |            |        |           |                      |
|         |   |            | >      |           |                      |
|         |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| (c.1)   |   | (c.2)      |        |           |                      |
| Maximum |   | Maximum    |        |           |                      |
| number  |   | number of  |        |           |                      |
| of      |   | doses per  |        |           |                      |
| doses   |   | subject    |        |           |                      |
| per     |   | per        |        |           |                      |
| subject |   |            |        |           |                      |
| per     |   | protocol   |        |           |                      |
| year    |   |            |        |           |                      |
|         |   | >          |        |           |                      |
|         |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **Study |   |            |        |           |                      |
| Drug    |   |            |        |           |                      |
| #2**    |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **      |   |            |        |           |                      |
| Provide |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| Refer   |   |            |        |           |                      |
| ence**, |   |            |        |           |                      |
| s       |   |            |        |           |                      |
| upplied |   |            |        |           |                      |
| by the  |   |            |        |           |                      |
| inves   |   |            |        |           |                      |
| tigator |   |            |        |           |                      |
| and/or  |   |            |        |           |                      |
| used by |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| RDRC,   |   |            |        |           |                      |
| to show |   |            |        |           |                      |
| that    |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| amount  |   |            |        |           |                      |
| of      |   |            |        |           |                      |
| active  |   |            |        |           |                      |
| ing     |   |            |        |           |                      |
| redient |   |            |        |           |                      |
| or      |   |            |        |           |                      |
| comb    |   |            |        |           |                      |
| ination |   |            |        |           |                      |
| of      |   |            |        |           |                      |
| active  |   |            |        |           |                      |
|         |   |            |        |           |                      |
| ingr    |   |            |        |           |                      |
| edients |   |            |        |           |                      |
| to be   |   |            |        |           |                      |
| admin   |   |            |        |           |                      |
| istered |   |            |        |           |                      |
| shall   |   |            |        |           |                      |
| be      |   |            |        |           |                      |
| known   |   |            |        |           |                      |
| not to  |   |            |        |           |                      |
| cause   |   |            |        |           |                      |
| any     |   |            |        |           |                      |
| cli     |   |            |        |           |                      |
| nically |   |            |        |           |                      |
| det     |   |            |        |           |                      |
| ectable |   |            |        |           |                      |
| p       |   |            |        |           |                      |
| harmaco |   |            |        |           |                      |
| logical |   |            |        |           |                      |
| effect  |   |            |        |           |                      |
| in      |   |            |        |           |                      |
| human   |   |            |        |           |                      |
| beings, |   |            |        |           |                      |
| based   |   |            |        |           |                      |
| on      |   |            |        |           |                      |
|         |   |            |        |           |                      |
| p       |   |            |        |           |                      |
| harmaco |   |            |        |           |                      |
| logical |   |            |        |           |                      |
| dose    |   |            |        |           |                      |
| calcu   |   |            |        |           |                      |
| lations |   |            |        |           |                      |
| on data |   |            |        |           |                      |
| av      |   |            |        |           |                      |
| ailable |   |            |        |           |                      |
| from    |   |            |        |           |                      |
| pu      |   |            |        |           |                      |
| blished |   |            |        |           |                      |
| lit     |   |            |        |           |                      |
| erature |   |            |        |           |                      |
| or from |   |            |        |           |                      |
| other   |   |            |        |           |                      |
| valid   |   |            |        |           |                      |
| human   |   |            |        |           |                      |
| studies |   |            |        |           |                      |
| \[21    |   |            |        |           |                      |
| CFR     |   |            |        |           |                      |
| 361.1   |   |            |        |           |                      |
| (b)(2)  |   |            |        |           |                      |
| and     |   |            |        |           |                      |
| (d      |   |            |        |           |                      |
| )(2)\]. |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **      |   |            |        |           |                      |
|      ** |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| \(a\)   |   |            |        |           |                      |
| Name of |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| **no    |   |            |        |           |                      |
| nradioa |   |            |        |           |                      |
| ctive** |   |            |        |           |                      |
| drug    |   |            |        |           |                      |
|         |   |            |        |           |                      |
| > **    |   |            |        |           |                      |
|      ** |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| \(b\)   |   |            |        |           |                      |
| Mass    |   |            |        |           |                      |
| dose    |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| > (b.1) |   |            |        | (b.2)     |                      |
| >       |   |            |        | No-obs    |                      |
| Maximum |   |            |        | erved-eff |                      |
| > mass  |   |            |        | ect-level |                      |
| > dose  |   |            |        | (NOEL)    |                      |
| >       |   |            |        | mass dose |                      |
| (i.e.µ, |   |            |        |           |                      |
| > g or  |   |            |        | >         |                      |
| > mg)   |   |            |        |           |                      |
| > of    |   |            |        |           |                      |
| >       |   |            |        |           |                      |
|  ***non |   |            |        |           |                      |
| radioac |   |            |        |           |                      |
| tive*** |   |            |        |           |                      |
| > drug  |   |            |        |           |                      |
| > admin |   |            |        |           |                      |
| istered |   |            |        |           |                      |
| > per   |   |            |        |           |                      |
| > s     |   |            |        |           |                      |
| ubject, |   |            |        |           |                      |
| > per   |   |            |        |           |                      |
| >       |   |            |        |           |                      |
|  single |   |            |        |           |                      |
| > dose  |   |            |        |           |                      |
| >       |   |            |        |           |                      |
| >       |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| > c\.   |   |            | \(d\)  |           | \(e\) If the radio   |
| >       |   |            | Route  |           | active drug or       |
|  Number |   |            | of     |           | nonradioactive drug  |
| > of    |   |            | adm    |           | is under an IND,     |
| > doses |   |            | inistr |           | list IND Number.     |
| > per   |   |            | ation\ |           |                      |
| > s     |   |            | (i.e., |           | >                    |
| ubject. |   |            | I.V.,  |           |                      |
|         |   |            | P.O.,  |           |                      |
|         |   |            | etc.)  |           |                      |
|         |   |            |        |           |                      |
|         |   |            | >      |           |                      |
|         |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| (c.1)   |   | (c.2)      |        |           |                      |
| Maximum |   | Maximum    |        |           |                      |
| number  |   | number of  |        |           |                      |
| of      |   | doses per  |        |           |                      |
| doses   |   | subject    |        |           |                      |
| per     |   | per        |        |           |                      |
| subject |   |            |        |           |                      |
| per     |   | protocol   |        |           |                      |
| year    |   |            |        |           |                      |
|         |   | >          |        |           |                      |
|         |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **Study |   |            |        |           |                      |
| Drug    |   |            |        |           |                      |
| #3**    |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **      |   |            |        |           |                      |
| Provide |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| Refer   |   |            |        |           |                      |
| ence**, |   |            |        |           |                      |
| s       |   |            |        |           |                      |
| upplied |   |            |        |           |                      |
| by the  |   |            |        |           |                      |
| inves   |   |            |        |           |                      |
| tigator |   |            |        |           |                      |
| and/or  |   |            |        |           |                      |
| used by |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| RDRC,   |   |            |        |           |                      |
| to show |   |            |        |           |                      |
| that    |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| amount  |   |            |        |           |                      |
| of      |   |            |        |           |                      |
| active  |   |            |        |           |                      |
| ing     |   |            |        |           |                      |
| redient |   |            |        |           |                      |
| or      |   |            |        |           |                      |
| comb    |   |            |        |           |                      |
| ination |   |            |        |           |                      |
| of      |   |            |        |           |                      |
| active  |   |            |        |           |                      |
|         |   |            |        |           |                      |
| ingr    |   |            |        |           |                      |
| edients |   |            |        |           |                      |
| to be   |   |            |        |           |                      |
| admin   |   |            |        |           |                      |
| istered |   |            |        |           |                      |
| shall   |   |            |        |           |                      |
| be      |   |            |        |           |                      |
| known   |   |            |        |           |                      |
| not to  |   |            |        |           |                      |
| cause   |   |            |        |           |                      |
| any     |   |            |        |           |                      |
| cli     |   |            |        |           |                      |
| nically |   |            |        |           |                      |
| det     |   |            |        |           |                      |
| ectable |   |            |        |           |                      |
| p       |   |            |        |           |                      |
| harmaco |   |            |        |           |                      |
| logical |   |            |        |           |                      |
| effect  |   |            |        |           |                      |
| in      |   |            |        |           |                      |
| human   |   |            |        |           |                      |
| beings, |   |            |        |           |                      |
| based   |   |            |        |           |                      |
| on      |   |            |        |           |                      |
|         |   |            |        |           |                      |
| p       |   |            |        |           |                      |
| harmaco |   |            |        |           |                      |
| logical |   |            |        |           |                      |
| dose    |   |            |        |           |                      |
| calcu   |   |            |        |           |                      |
| lations |   |            |        |           |                      |
| on data |   |            |        |           |                      |
| av      |   |            |        |           |                      |
| ailable |   |            |        |           |                      |
| from    |   |            |        |           |                      |
| pu      |   |            |        |           |                      |
| blished |   |            |        |           |                      |
| lit     |   |            |        |           |                      |
| erature |   |            |        |           |                      |
| or from |   |            |        |           |                      |
| other   |   |            |        |           |                      |
| valid   |   |            |        |           |                      |
| human   |   |            |        |           |                      |
| studies |   |            |        |           |                      |
| \[21    |   |            |        |           |                      |
| CFR     |   |            |        |           |                      |
| 361.1   |   |            |        |           |                      |
| (b)(2)  |   |            |        |           |                      |
| and     |   |            |        |           |                      |
| (d      |   |            |        |           |                      |
| )(2)\]. |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **      |   |            |        |           |                      |
|      ** |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| \(a\)   |   |            |        |           |                      |
| Name of |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| **no    |   |            |        |           |                      |
| nradioa |   |            |        |           |                      |
| ctive** |   |            |        |           |                      |
| drug    |   |            |        |           |                      |
|         |   |            |        |           |                      |
| > **    |   |            |        |           |                      |
|      ** |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| \(b\)   |   |            |        |           |                      |
| Mass    |   |            |        |           |                      |
| dose    |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| > (b.1) |   |            |        | (b.2)     |                      |
| >       |   |            |        | No-obs    |                      |
| Maximum |   |            |        | erved-eff |                      |
| > mass  |   |            |        | ect-level |                      |
| > dose  |   |            |        | (NOEL)    |                      |
| >       |   |            |        | mass dose |                      |
| (i.e.µ, |   |            |        |           |                      |
| > g or  |   |            |        | >         |                      |
| > mg)   |   |            |        |           |                      |
| > of    |   |            |        |           |                      |
| >       |   |            |        |           |                      |
|  ***non |   |            |        |           |                      |
| radioac |   |            |        |           |                      |
| tive*** |   |            |        |           |                      |
| > drug  |   |            |        |           |                      |
| > admin |   |            |        |           |                      |
| istered |   |            |        |           |                      |
| > per   |   |            |        |           |                      |
| > s     |   |            |        |           |                      |
| ubject, |   |            |        |           |                      |
| > per   |   |            |        |           |                      |
| >       |   |            |        |           |                      |
|  single |   |            |        |           |                      |
| > dose  |   |            |        |           |                      |
| >       |   |            |        |           |                      |
| >       |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| > c\.   |   |            | \(d\)  |           | \(e\) If the radio   |
| >       |   |            | Route  |           | active drug or       |
|  Number |   |            | of     |           | nonradioactive drug  |
| > of    |   |            | adm    |           | is under an IND,     |
| > doses |   |            | inistr |           | list IND Number.     |
| > per   |   |            | ation\ |           |                      |
| > s     |   |            | (i.e., |           | >                    |
| ubject. |   |            | I.V.,  |           |                      |
|         |   |            | P.O.,  |           |                      |
|         |   |            | etc.)  |           |                      |
|         |   |            |        |           |                      |
|         |   |            | >      |           |                      |
|         |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| (c.1)   |   | (c.2)      |        |           |                      |
| Maximum |   | Maximum    |        |           |                      |
| number  |   | number of  |        |           |                      |
| of      |   | doses per  |        |           |                      |
| doses   |   | subject    |        |           |                      |
| per     |   | per        |        |           |                      |
| subject |   |            |        |           |                      |
| per     |   | protocol   |        |           |                      |
| year    |   |            |        |           |                      |
|         |   | >          |        |           |                      |
|         |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+

+---------+---+------------+--------+-----------+----------------------+
| **B.    |   |            |        |           |                      |
| S       |   |            |        |           |                      |
| PECIFIC |   |            |        |           |                      |
| INFO    |   |            |        |           |                      |
| RMATION |   |            |        |           |                      |
| *       |   |            |        |           |                      |
| (Contin |   |            |        |           |                      |
| ued)*** |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| 4\.     |   |            |        |           |                      |
| P       |   |            |        |           |                      |
| HARMACO |   |            |        |           |                      |
| LOGICAL |   |            |        |           |                      |
| DOSE    |   |            |        |           |                      |
| *(Cont  |   |            |        |           |                      |
| inued)* |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **Study |   |            |        |           |                      |
| Drug    |   |            |        |           |                      |
| #4**    |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **      |   |            |        |           |                      |
| Provide |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| Refer   |   |            |        |           |                      |
| ence**, |   |            |        |           |                      |
| s       |   |            |        |           |                      |
| upplied |   |            |        |           |                      |
| by the  |   |            |        |           |                      |
| inves   |   |            |        |           |                      |
| tigator |   |            |        |           |                      |
| and/or  |   |            |        |           |                      |
| used by |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| RDRC,   |   |            |        |           |                      |
| to show |   |            |        |           |                      |
| that    |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| amount  |   |            |        |           |                      |
| of      |   |            |        |           |                      |
| active  |   |            |        |           |                      |
| ing     |   |            |        |           |                      |
| redient |   |            |        |           |                      |
| or      |   |            |        |           |                      |
| comb    |   |            |        |           |                      |
| ination |   |            |        |           |                      |
| of      |   |            |        |           |                      |
| active  |   |            |        |           |                      |
|         |   |            |        |           |                      |
| ingr    |   |            |        |           |                      |
| edients |   |            |        |           |                      |
| to be   |   |            |        |           |                      |
| admin   |   |            |        |           |                      |
| istered |   |            |        |           |                      |
| shall   |   |            |        |           |                      |
| be      |   |            |        |           |                      |
| known   |   |            |        |           |                      |
| not to  |   |            |        |           |                      |
| cause   |   |            |        |           |                      |
| any     |   |            |        |           |                      |
| cli     |   |            |        |           |                      |
| nically |   |            |        |           |                      |
| det     |   |            |        |           |                      |
| ectable |   |            |        |           |                      |
| p       |   |            |        |           |                      |
| harmaco |   |            |        |           |                      |
| logical |   |            |        |           |                      |
| effect  |   |            |        |           |                      |
| in      |   |            |        |           |                      |
| human   |   |            |        |           |                      |
| beings, |   |            |        |           |                      |
| based   |   |            |        |           |                      |
| on      |   |            |        |           |                      |
|         |   |            |        |           |                      |
| p       |   |            |        |           |                      |
| harmaco |   |            |        |           |                      |
| logical |   |            |        |           |                      |
| dose    |   |            |        |           |                      |
| calcu   |   |            |        |           |                      |
| lations |   |            |        |           |                      |
| on data |   |            |        |           |                      |
| av      |   |            |        |           |                      |
| ailable |   |            |        |           |                      |
| from    |   |            |        |           |                      |
| pu      |   |            |        |           |                      |
| blished |   |            |        |           |                      |
| lit     |   |            |        |           |                      |
| erature |   |            |        |           |                      |
| or from |   |            |        |           |                      |
| other   |   |            |        |           |                      |
| valid   |   |            |        |           |                      |
| human   |   |            |        |           |                      |
| studies |   |            |        |           |                      |
| \[21    |   |            |        |           |                      |
| CFR     |   |            |        |           |                      |
| 361.1   |   |            |        |           |                      |
| (b)(2)  |   |            |        |           |                      |
| and     |   |            |        |           |                      |
| (d      |   |            |        |           |                      |
| )(2)\]. |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **      |   |            |        |           |                      |
|      ** |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| \(a\)   |   |            |        |           |                      |
| Name of |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| **no    |   |            |        |           |                      |
| nradioa |   |            |        |           |                      |
| ctive** |   |            |        |           |                      |
| drug    |   |            |        |           |                      |
|         |   |            |        |           |                      |
| > **    |   |            |        |           |                      |
|      ** |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| \(b\)   |   |            |        |           |                      |
| Mass    |   |            |        |           |                      |
| dose    |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| > (b.1) |   |            |        | > (b.1)   |                      |
| >       |   |            |        | > Maximum |                      |
| Maximum |   |            |        | > mass    |                      |
| > mass  |   |            |        | > dose    |                      |
| > dose  |   |            |        | > (i.e.µ, |                      |
| >       |   |            |        | > g or    |                      |
| (i.e.µ, |   |            |        | > mg) of  |                      |
| > g or  |   |            |        | > **      |                      |
| > mg)   |   |            |        | *nonradio |                      |
| > of    |   |            |        | active*** |                      |
| >       |   |            |        | > drug    |                      |
|  ***non |   |            |        | > adm     |                      |
| radioac |   |            |        | inistered |                      |
| tive*** |   |            |        | > per     |                      |
| > drug  |   |            |        | >         |                      |
| > admin |   |            |        |  subject, |                      |
| istered |   |            |        | > per     |                      |
| > per   |   |            |        | > single  |                      |
| > s     |   |            |        | > dose    |                      |
| ubject, |   |            |        | >         |                      |
| > per   |   |            |        | >         |                      |
| >       |   |            |        |           |                      |
|  single |   |            |        |           |                      |
| > dose  |   |            |        |           |                      |
| >       |   |            |        |           |                      |
| >       |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| > c\.   |   |            | \(d\)  |           | \(e\) If the radio   |
| >       |   |            | Route  |           | active drug or       |
|  Number |   |            | of     |           | nonradioactive drug  |
| > of    |   |            | adm    |           | is under an IND,     |
| > doses |   |            | inistr |           | list IND Number.     |
| > per   |   |            | ation\ |           |                      |
| > s     |   |            | (i.e., |           | >                    |
| ubject. |   |            | I.V.,  |           |                      |
|         |   |            | P.O.,  |           |                      |
|         |   |            | etc.)  |           |                      |
|         |   |            |        |           |                      |
|         |   |            | >      |           |                      |
|         |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| (c.1)   |   | (c.2)      |        |           |                      |
| Maximum |   | Maximum    |        |           |                      |
| number  |   | number of  |        |           |                      |
| of      |   | doses per  |        |           |                      |
| doses   |   | subject    |        |           |                      |
| per     |   | per        |        |           |                      |
| subject |   |            |        |           |                      |
| per     |   | protocol   |        |           |                      |
| year    |   |            |        |           |                      |
|         |   | >          |        |           |                      |
|         |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **Study |   |            |        |           |                      |
| Drug    |   |            |        |           |                      |
| #5**    |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **      |   |            |        |           |                      |
| Provide |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| Refer   |   |            |        |           |                      |
| ence**, |   |            |        |           |                      |
| s       |   |            |        |           |                      |
| upplied |   |            |        |           |                      |
| by the  |   |            |        |           |                      |
| inves   |   |            |        |           |                      |
| tigator |   |            |        |           |                      |
| and/or  |   |            |        |           |                      |
| used by |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| RDRC,   |   |            |        |           |                      |
| to show |   |            |        |           |                      |
| that    |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| amount  |   |            |        |           |                      |
| of      |   |            |        |           |                      |
| active  |   |            |        |           |                      |
| ing     |   |            |        |           |                      |
| redient |   |            |        |           |                      |
| or      |   |            |        |           |                      |
| comb    |   |            |        |           |                      |
| ination |   |            |        |           |                      |
| of      |   |            |        |           |                      |
| active  |   |            |        |           |                      |
|         |   |            |        |           |                      |
| ingr    |   |            |        |           |                      |
| edients |   |            |        |           |                      |
| to be   |   |            |        |           |                      |
| admin   |   |            |        |           |                      |
| istered |   |            |        |           |                      |
| shall   |   |            |        |           |                      |
| be      |   |            |        |           |                      |
| known   |   |            |        |           |                      |
| not to  |   |            |        |           |                      |
| cause   |   |            |        |           |                      |
| any     |   |            |        |           |                      |
| cli     |   |            |        |           |                      |
| nically |   |            |        |           |                      |
| det     |   |            |        |           |                      |
| ectable |   |            |        |           |                      |
| p       |   |            |        |           |                      |
| harmaco |   |            |        |           |                      |
| logical |   |            |        |           |                      |
| effect  |   |            |        |           |                      |
| in      |   |            |        |           |                      |
| human   |   |            |        |           |                      |
| beings, |   |            |        |           |                      |
| based   |   |            |        |           |                      |
| on      |   |            |        |           |                      |
|         |   |            |        |           |                      |
| p       |   |            |        |           |                      |
| harmaco |   |            |        |           |                      |
| logical |   |            |        |           |                      |
| dose    |   |            |        |           |                      |
| calcu   |   |            |        |           |                      |
| lations |   |            |        |           |                      |
| on data |   |            |        |           |                      |
| av      |   |            |        |           |                      |
| ailable |   |            |        |           |                      |
| from    |   |            |        |           |                      |
| pu      |   |            |        |           |                      |
| blished |   |            |        |           |                      |
| lit     |   |            |        |           |                      |
| erature |   |            |        |           |                      |
| or from |   |            |        |           |                      |
| other   |   |            |        |           |                      |
| valid   |   |            |        |           |                      |
| human   |   |            |        |           |                      |
| studies |   |            |        |           |                      |
| \[21    |   |            |        |           |                      |
| CFR     |   |            |        |           |                      |
| 361.1   |   |            |        |           |                      |
| (b)(2)  |   |            |        |           |                      |
| and     |   |            |        |           |                      |
| (d      |   |            |        |           |                      |
| )(2)\]. |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **      |   |            |        |           |                      |
|      ** |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| \(a\)   |   |            |        |           |                      |
| Name of |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| **no    |   |            |        |           |                      |
| nradioa |   |            |        |           |                      |
| ctive** |   |            |        |           |                      |
| drug    |   |            |        |           |                      |
|         |   |            |        |           |                      |
| > **    |   |            |        |           |                      |
|      ** |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| \(b\)   |   |            |        |           |                      |
| Mass    |   |            |        |           |                      |
| dose    |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| > (b.1) |   |            |        | > (b.1)   |                      |
| >       |   |            |        | > Maximum |                      |
| Maximum |   |            |        | > mass    |                      |
| > mass  |   |            |        | > dose    |                      |
| > dose  |   |            |        | > (i.e.µ, |                      |
| >       |   |            |        | > g or    |                      |
| (i.e.µ, |   |            |        | > mg) of  |                      |
| > g or  |   |            |        | > **      |                      |
| > mg)   |   |            |        | *nonradio |                      |
| > of    |   |            |        | active*** |                      |
| >       |   |            |        | > drug    |                      |
|  ***non |   |            |        | > adm     |                      |
| radioac |   |            |        | inistered |                      |
| tive*** |   |            |        | > per     |                      |
| > drug  |   |            |        | >         |                      |
| > admin |   |            |        |  subject, |                      |
| istered |   |            |        | > per     |                      |
| > per   |   |            |        | > single  |                      |
| > s     |   |            |        | > dose    |                      |
| ubject, |   |            |        | >         |                      |
| > per   |   |            |        | >         |                      |
| >       |   |            |        |           |                      |
|  single |   |            |        |           |                      |
| > dose  |   |            |        |           |                      |
| >       |   |            |        |           |                      |
| >       |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| > c\.   |   |            | \(d\)  |           | \(e\) If the radio   |
| >       |   |            | Route  |           | active drug or       |
|  Number |   |            | of     |           | nonradioactive drug  |
| > of    |   |            | adm    |           | is under an IND,     |
| > doses |   |            | inistr |           | list IND Number.     |
| > per   |   |            | ation\ |           |                      |
| > s     |   |            | (i.e., |           | >                    |
| ubject. |   |            | I.V.,  |           |                      |
|         |   |            | P.O.,  |           |                      |
|         |   |            | etc.)  |           |                      |
|         |   |            |        |           |                      |
|         |   |            | >      |           |                      |
|         |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| (c.1)   |   | (c.2)      |        |           |                      |
| Maximum |   | Maximum    |        |           |                      |
| number  |   | number of  |        |           |                      |
| of      |   | doses per  |        |           |                      |
| doses   |   | subject    |        |           |                      |
| per     |   | per        |        |           |                      |
| subject |   |            |        |           |                      |
| per     |   | protocol   |        |           |                      |
| year    |   |            |        |           |                      |
|         |   | >          |        |           |                      |
|         |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **Study |   |            |        |           |                      |
| Drug    |   |            |        |           |                      |
| #6**    |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **      |   |            |        |           |                      |
| Provide |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| Refer   |   |            |        |           |                      |
| ence**, |   |            |        |           |                      |
| s       |   |            |        |           |                      |
| upplied |   |            |        |           |                      |
| by the  |   |            |        |           |                      |
| inves   |   |            |        |           |                      |
| tigator |   |            |        |           |                      |
| and/or  |   |            |        |           |                      |
| used by |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| RDRC,   |   |            |        |           |                      |
| to show |   |            |        |           |                      |
| that    |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| amount  |   |            |        |           |                      |
| of      |   |            |        |           |                      |
| active  |   |            |        |           |                      |
| ing     |   |            |        |           |                      |
| redient |   |            |        |           |                      |
| or      |   |            |        |           |                      |
| comb    |   |            |        |           |                      |
| ination |   |            |        |           |                      |
| of      |   |            |        |           |                      |
| active  |   |            |        |           |                      |
|         |   |            |        |           |                      |
| ingr    |   |            |        |           |                      |
| edients |   |            |        |           |                      |
| to be   |   |            |        |           |                      |
| admin   |   |            |        |           |                      |
| istered |   |            |        |           |                      |
| shall   |   |            |        |           |                      |
| be      |   |            |        |           |                      |
| known   |   |            |        |           |                      |
| not to  |   |            |        |           |                      |
| cause   |   |            |        |           |                      |
| any     |   |            |        |           |                      |
| cli     |   |            |        |           |                      |
| nically |   |            |        |           |                      |
| det     |   |            |        |           |                      |
| ectable |   |            |        |           |                      |
| p       |   |            |        |           |                      |
| harmaco |   |            |        |           |                      |
| logical |   |            |        |           |                      |
| effect  |   |            |        |           |                      |
| in      |   |            |        |           |                      |
| human   |   |            |        |           |                      |
| beings, |   |            |        |           |                      |
| based   |   |            |        |           |                      |
| on      |   |            |        |           |                      |
|         |   |            |        |           |                      |
| p       |   |            |        |           |                      |
| harmaco |   |            |        |           |                      |
| logical |   |            |        |           |                      |
| dose    |   |            |        |           |                      |
| calcu   |   |            |        |           |                      |
| lations |   |            |        |           |                      |
| on data |   |            |        |           |                      |
| av      |   |            |        |           |                      |
| ailable |   |            |        |           |                      |
| from    |   |            |        |           |                      |
| pu      |   |            |        |           |                      |
| blished |   |            |        |           |                      |
| lit     |   |            |        |           |                      |
| erature |   |            |        |           |                      |
| or from |   |            |        |           |                      |
| other   |   |            |        |           |                      |
| valid   |   |            |        |           |                      |
| human   |   |            |        |           |                      |
| studies |   |            |        |           |                      |
| \[21    |   |            |        |           |                      |
| CFR     |   |            |        |           |                      |
| 361.1   |   |            |        |           |                      |
| (b)(2)  |   |            |        |           |                      |
| and     |   |            |        |           |                      |
| (d      |   |            |        |           |                      |
| )(2)\]. |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| **      |   |            |        |           |                      |
|      ** |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| \(a\)   |   |            |        |           |                      |
| Name of |   |            |        |           |                      |
| the     |   |            |        |           |                      |
| **no    |   |            |        |           |                      |
| nradioa |   |            |        |           |                      |
| ctive** |   |            |        |           |                      |
| drug    |   |            |        |           |                      |
|         |   |            |        |           |                      |
| > **    |   |            |        |           |                      |
|      ** |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| \(b\)   |   |            |        |           |                      |
| Mass    |   |            |        |           |                      |
| dose    |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| > (b.1) |   |            |        | > (b.1)   |                      |
| >       |   |            |        | > Maximum |                      |
| Maximum |   |            |        | > mass    |                      |
| > mass  |   |            |        | > dose    |                      |
| > dose  |   |            |        | > (i.e.µ, |                      |
| >       |   |            |        | > g or    |                      |
| (i.e.µ, |   |            |        | > mg) of  |                      |
| > g or  |   |            |        | > **      |                      |
| > mg)   |   |            |        | *nonradio |                      |
| > of    |   |            |        | active*** |                      |
| >       |   |            |        | > drug    |                      |
|  ***non |   |            |        | > adm     |                      |
| radioac |   |            |        | inistered |                      |
| tive*** |   |            |        | > per     |                      |
| > drug  |   |            |        | >         |                      |
| > admin |   |            |        |  subject, |                      |
| istered |   |            |        | > per     |                      |
| > per   |   |            |        | > single  |                      |
| > s     |   |            |        | > dose    |                      |
| ubject, |   |            |        | >         |                      |
| > per   |   |            |        | >         |                      |
| >       |   |            |        |           |                      |
|  single |   |            |        |           |                      |
| > dose  |   |            |        |           |                      |
| >       |   |            |        |           |                      |
| >       |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| > c\.   |   |            | \(d\)  |           | \(e\) If the radio   |
| >       |   |            | Route  |           | active drug or       |
|  Number |   |            | of     |           | nonradioactive drug  |
| > of    |   |            | adm    |           | is under an IND,     |
| > doses |   |            | inistr |           | list IND Number.     |
| > per   |   |            | ation\ |           |                      |
| > s     |   |            | (i.e., |           | >                    |
| ubject. |   |            | I.V.,  |           |                      |
|         |   |            | P.O.,  |           |                      |
|         |   |            | etc.)  |           |                      |
|         |   |            |        |           |                      |
|         |   |            | >      |           |                      |
|         |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
| (c.1)   |   | (c.2)      |        |           |                      |
| Maximum |   | Maximum    |        |           |                      |
| number  |   | number of  |        |           |                      |
| of      |   | doses per  |        |           |                      |
| doses   |   | subject    |        |           |                      |
| per     |   | per        |        |           |                      |
| subject |   |            |        |           |                      |
| per     |   | protocol   |        |           |                      |
| year    |   |            |        |           |                      |
|         |   | >          |        |           |                      |
|         |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+
|         |   |            |        |           |                      |
+---------+---+------------+--------+-----------+----------------------+

+---+------+---------------------------------------+---------+---------+
| # |      |                                       |         |         |
| # |      |                                       |         |         |
| # |      |                                       |         |         |
| # |      |                                       |         |         |
| # |      |                                       |         |         |
| # |      |                                       |         |         |
| # |      |                                       |         |         |
| # |      |                                       |         |         |
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| d |      |                                       |         |         |
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+---+------+---------------------------------------+---------+---------+
| 5 |      |                                       |         |         |
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| t |    |   |               |                      |                      |
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| " |    |   |               |                      |                      |
| S |    |   |               |                      |                      |
| p |    |   |               |                      |                      |
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| c |    |   |               |                      |                      |
| i |    |   |               |                      |                      |
| f |    |   |               |                      |                      |
| i |    |   |               |                      |                      |
| c |    |   |               |                      |                      |
| I |    |   |               |                      |                      |
| n |    |   |               |                      |                      |
| s |    |   |               |                      |                      |
| t |    |   |               |                      |                      |
| r |    |   |               |                      |                      |
| u |    |   |               |                      |                      |
| c |    |   |               |                      |                      |
| t |    |   |               |                      |                      |
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| s |    |   |               |                      |                      |
| \ |    |   |               |                      |                      |
| " |    |   |               |                      |                      |
| p |    |   |               |                      |                      |
| a |    |   |               |                      |                      |
| g |    |   |               |                      |                      |
| e |    |   |               |                      |                      |
| s |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
| f |    |   |               |                      |                      |
| o |    |   |               |                      |                      |
| r |    |   |               |                      |                      |
| m |    |   |               |                      |                      |
| o |    |   |               |                      |                      |
| r |    |   |               |                      |                      |
| e |    |   |               |                      |                      |
| i |    |   |               |                      |                      |
| n |    |   |               |                      |                      |
| f |    |   |               |                      |                      |
| o |    |   |               |                      |                      |
| r |    |   |               |                      |                      |
| m |    |   |               |                      |                      |
| a |    |   |               |                      |                      |
| t |    |   |               |                      |                      |
| i |    |   |               |                      |                      |
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| ) |    |   |               |                      |                      |
| . |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
| a |    |   | b\.           | c\.                  | d\.                  |
| \ |    |   |               |                      |                      |
| . |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
| A | S  |   | ACTIVITY OF   | ABSORBED DOSE        | TOTAL DOSE\          |
| G | EX |   | RADIOACTIVE   |                      | PER ORGAN / PER YEAR |
| E |    |   |               | PER SINGLE           |                      |
|   |    |   | STUDY DRUG(S) | ADMINISTRATION       |                      |
|   |    |   |               |                      |                      |
|   |    |   | ADMINISTERED  | *(for each           |                      |
|   |    |   | AND OTHER     | radioactive study    |                      |
|   |    |   |               | drug)*               |                      |
|   |    |   | ASSOCIATED    |                      |                      |
|   |    |   | PROCEDURES    |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   | *Radioactive  | *From Radioactive    | [     ]{.underline}  |
|   |    |   | Drug*         | Drug*                | mSv (Rem) / whole    |
|   |    |   |               |                      | body                 |
|   |    |   | > [           | [     ]{.underline}  |                      |
|   |    |   | ]{.underline} | mSv (Rem) / whole    | [     ]{.underline}  |
|   |    |   | > MBq         | body                 | mSv (Rem) / lens of  |
|   |    |   | >             |                      | eye                  |
|   |    |   | > *or*        | [     ]{.underline}  |                      |
|   |    |   | >             | mSv (Rem) / lens of  | [     ]{.underline}  |
|   |    |   | > [           | eye                  | mSv (Rem) / gonads   |
|   |    |   | ]{.underline} |                      |                      |
|   |    |   | > µCi         | [     ]{.underline}  | [     ]{.underline}  |
|   |    |   | >             | mSv (Rem) / gonads   | mSv (Rem) /          |
|   |    |   | > *or*        |                      |                      |
|   |    |   | >             | [     ]{.underline}  | (critical organ)     |
|   |    |   | > [           | mSv (Rem) /          |                      |
|   |    |   | ]{.underline} |                      | [     ]{.underline}  |
|   |    |   | > mCi         | (critical organ)     | mSv (Rem) /          |
|   |    |   | >             |                      |                      |
|   |    |   | > of          | [     ]{.underline}  | (Blood forming       |
|   |    |   | > [           | mSv (Rem) /          |                      |
|   |    |   | ]{.underline} |                      | organ)               |
|   |    |   | >             | (Blood forming       |                      |
|   |    |   | >             |                      |                      |
|   |    |   |  *radioactive | organ)               |                      |
|   |    |   | > study drug* |                      |                      |
|   |    |   | >             | *From Other          |                      |
|   |    |   | > *Other      | Associated           |                      |
|   |    |   | > Associated  | Procedures*          |                      |
|   |    |   | > Procedures* |                      |                      |
|   |    |   | >             | [     ]{.underline}  |                      |
|   |    |   | > PET         | mSv (Rem) / whole    |                      |
|   |    |   | >             | body                 |                      |
|   |    |   |  transmission |                      |                      |
|   |    |   | > scans       | [     ]{.underline}  |                      |
|   |    |   | >             | mSv (Rem) / lens of  |                      |
|   |    |   | > CT          | eye                  |                      |
|   |    |   | >             |                      |                      |
|   |    |   | > DEXA        | [     ]{.underline}  |                      |
|   |    |   | >             | mSv (Rem) / gonads   |                      |
|   |    |   | > X-Ray       |                      |                      |
|   |    |   | >             | [     ]{.underline}  |                      |
|   |    |   | > Other       | mSv (Rem) /          |                      |
|   |    |   | >             |                      |                      |
|   |    |   |  *(Specify:)* | (critical organ)     |                      |
|   |    |   | >             |                      |                      |
|   |    |   | > [           | [     ]{.underline}  |                      |
|   |    |   | ]{.underline} | mSv (Rem) /          |                      |
|   |    |   |               |                      |                      |
|   |    |   |               | (Blood forming       |                      |
|   |    |   |               |                      |                      |
|   |    |   |               | organ)               |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      | *Additional comments |
|   |    |   |               |                      | or information, if   |
|   |    |   |               |                      | any,\                |
|   |    |   |               |                      | regarding Total      |
|   |    |   |               |                      | Dose:*               |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
| * |    |   |               |                      |                      |
| * |    |   |               |                      |                      |
| F |    |   |               |                      |                      |
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| T |    |   |               |                      |                      |
| : |    |   |               |                      |                      |
| * |    |   |               |                      |                      |
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| g |    |   |               |                      |                      |
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| p |    |   |               |                      |                      |
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| d |    |   |               |                      |                      |
| f |    |   |               |                      |                      |
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| m |    |   |               |                      |                      |
| a |    |   |               |                      |                      |
| t |    |   |               |                      |                      |
| ( |    |   |               |                      |                      |
| r |    |   |               |                      |                      |
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| t |    |   |               |                      |                      |
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| \ |    |   |               |                      |                      |
| " |    |   |               |                      |                      |
| S |    |   |               |                      |                      |
| p |    |   |               |                      |                      |
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| c |    |   |               |                      |                      |
| i |    |   |               |                      |                      |
| f |    |   |               |                      |                      |
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| c |    |   |               |                      |                      |
| I |    |   |               |                      |                      |
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| s |    |   |               |                      |                      |
| t |    |   |               |                      |                      |
| r |    |   |               |                      |                      |
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| t |    |   |               |                      |                      |
| i |    |   |               |                      |                      |
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| s |    |   |               |                      |                      |
| \ |    |   |               |                      |                      |
| " |    |   |               |                      |                      |
| p |    |   |               |                      |                      |
| a |    |   |               |                      |                      |
| g |    |   |               |                      |                      |
| e |    |   |               |                      |                      |
| s |    |   |               |                      |                      |
| f |    |   |               |                      |                      |
| o |    |   |               |                      |                      |
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|   |    |   |               |                      |                      |
| m |    |   |               |                      |                      |
| o |    |   |               |                      |                      |
| r |    |   |               |                      |                      |
| e |    |   |               |                      |                      |
| i |    |   |               |                      |                      |
| n |    |   |               |                      |                      |
| f |    |   |               |                      |                      |
| o |    |   |               |                      |                      |
| r |    |   |               |                      |                      |
| m |    |   |               |                      |                      |
| a |    |   |               |                      |                      |
| t |    |   |               |                      |                      |
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| n |    |   |               |                      |                      |
| ) |    |   |               |                      |                      |
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+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
|   |    |   |               |                      |                      |
+---+----+---+---------------+----------------------+----------------------+

+---+---+---------------+----------------------+----------------------+
| # |   |               |                      |                      |
| # |   |               |                      |                      |
| # |   |               |                      |                      |
| # |   |               |                      |                      |
| # |   |               |                      |                      |
| # |   |               |                      |                      |
| # |   |               |                      |                      |
| # |   |               |                      |                      |
| # |   |               |                      |                      |
|   |   |               |                      |                      |
| B |   |               |                      |                      |
| . |   |               |                      |                      |
|   |   |               |                      |                      |
| S |   |               |                      |                      |
| P |   |               |                      |                      |
| E |   |               |                      |                      |
| C |   |               |                      |                      |
| I |   |               |                      |                      |
| F |   |               |                      |                      |
| I |   |               |                      |                      |
| C |   |               |                      |                      |
|   |   |               |                      |                      |
| I |   |               |                      |                      |
| N |   |               |                      |                      |
| F |   |               |                      |                      |
| O |   |               |                      |                      |
| R |   |               |                      |                      |
| M |   |               |                      |                      |
| A |   |               |                      |                      |
| T |   |               |                      |                      |
| I |   |               |                      |                      |
| O |   |               |                      |                      |
| N |   |               |                      |                      |
|   |   |               |                      |                      |
| * |   |               |                      |                      |
| ( |   |               |                      |                      |
| C |   |               |                      |                      |
| o |   |               |                      |                      |
| n |   |               |                      |                      |
| t |   |               |                      |                      |
| i |   |               |                      |                      |
| n |   |               |                      |                      |
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| e |   |               |                      |                      |
| d |   |               |                      |                      |
| ) |   |               |                      |                      |
| * |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
| # |   |               |                      |                      |
| # |   |               |                      |                      |
| # |   |               |                      |                      |
| # |   |               |                      |                      |
| # |   |               |                      |                      |
| # |   |               |                      |                      |
| # |   |               |                      |                      |
| # |   |               |                      |                      |
| # |   |               |                      |                      |
|   |   |               |                      |                      |
| 6 |   |               |                      |                      |
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|   |   |               |                      |                      |
| R |   |               |                      |                      |
| A |   |               |                      |                      |
| D |   |               |                      |                      |
| I |   |               |                      |                      |
| A |   |               |                      |                      |
| T |   |               |                      |                      |
| I |   |               |                      |                      |
| O |   |               |                      |                      |
| N |   |               |                      |                      |
|   |   |               |                      |                      |
| A |   |               |                      |                      |
| B |   |               |                      |                      |
| S |   |               |                      |                      |
| O |   |               |                      |                      |
| R |   |               |                      |                      |
| B |   |               |                      |                      |
| E |   |               |                      |                      |
| D |   |               |                      |                      |
|   |   |               |                      |                      |
| D |   |               |                      |                      |
| O |   |               |                      |                      |
| S |   |               |                      |                      |
| E |   |               |                      |                      |
|   |   |               |                      |                      |
| * |   |               |                      |                      |
| ( |   |               |                      |                      |
| C |   |               |                      |                      |
| o |   |               |                      |                      |
| n |   |               |                      |                      |
| t |   |               |                      |                      |
| i |   |               |                      |                      |
| n |   |               |                      |                      |
| u |   |               |                      |                      |
| e |   |               |                      |                      |
| d |   |               |                      |                      |
| ) |   |               |                      |                      |
| * |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
| a |   | b\.           | c\.                  | d\.                  |
| \ |   |               |                      |                      |
| . |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
| A | S | ACTIVITY OF   | ABSORBED DOSE        | TOTAL DOSE\          |
| G | E | RADIOACTIVE   |                      | PER ORGAN / PER YEAR |
| E | X |               | PER SINGLE           |                      |
|   |   | STUDY DRUG(S) | ADMINISTRATION       |                      |
|   |   |               |                      |                      |
|   |   | ADMINISTERED  | *(for each           |                      |
|   |   | AND OTHER     | radioactive study    |                      |
|   |   |               | drug)*               |                      |
|   |   | ASSOCIATED    |                      |                      |
|   |   | PROCEDURES    |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
|   |   |               |                      |                      |
+---+---+---------------+----------------------+----------------------+

+---+---+------------+---+----------------------+--------+------------+
| # |   |            |   |                      |        |            |
| # |   |            |   |                      |        |            |
| # |   |            |   |                      |        |            |
| # |   |            |   |                      |        |            |
| # |   |            |   |                      |        |            |
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| . |   |            |   |                      |        |            |
|   |   |            |   |                      |        |            |
| S |   |            |   |                      |        |            |
| P |   |            |   |                      |        |            |
| E |   |            |   |                      |        |            |
| C |   |            |   |                      |        |            |
| I |   |            |   |                      |        |            |
| F |   |            |   |                      |        |            |
| I |   |            |   |                      |        |            |
| C |   |            |   |                      |        |            |
|   |   |            |   |                      |        |            |
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| N |   |            |   |                      |        |            |
| F |   |            |   |                      |        |            |
| O |   |            |   |                      |        |            |
| R |   |            |   |                      |        |            |
| M |   |            |   |                      |        |            |
| A |   |            |   |                      |        |            |
| T |   |            |   |                      |        |            |
| I |   |            |   |                      |        |            |
| O |   |            |   |                      |        |            |
| N |   |            |   |                      |        |            |
|   |   |            |   |                      |        |            |
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| d |   |            |   |                      |        |            |
| ) |   |            |   |                      |        |            |
| * |   |            |   |                      |        |            |
+---+---+------------+---+----------------------+--------+------------+
| # |   |            |   |                      |        |            |
| # |   |            |   |                      |        |            |
| # |   |            |   |                      |        |            |
| # |   |            |   |                      |        |            |
| # |   |            |   |                      |        |            |
| # |   |            |   |                      |        |            |
| # |   |            |   |                      |        |            |
| # |   |            |   |                      |        |            |
| # |   |            |   |                      |        |            |
|   |   |            |   |                      |        |            |
| 6 |   |            |   |                      |        |            |
| . |   |            |   |                      |        |            |
|   |   |            |   |                      |        |            |
| R |   |            |   |                      |        |            |
| A |   |            |   |                      |        |            |
| D |   |            |   |                      |        |            |
| I |   |            |   |                      |        |            |
| A |   |            |   |                      |        |            |
| T |   |            |   |                      |        |            |
| I |   |            |   |                      |        |            |
| O |   |            |   |                      |        |            |
| N |   |            |   |                      |        |            |
|   |   |            |   |                      |        |            |
| A |   |            |   |                      |        |            |
| B |   |            |   |                      |        |            |
| S |   |            |   |                      |        |            |
| O |   |            |   |                      |        |            |
| R |   |            |   |                      |        |            |
| B |   |            |   |                      |        |            |
| E |   |            |   |                      |        |            |
| D |   |            |   |                      |        |            |
|   |   |            |   |                      |        |            |
| D |   |            |   |                      |        |            |
| O |   |            |   |                      |        |            |
| S |   |            |   |                      |        |            |
| E |   |            |   |                      |        |            |
|   |   |            |   |                      |        |            |
| * |   |            |   |                      |        |            |
| ( |   |            |   |                      |        |            |
| C |   |            |   |                      |        |            |
| o |   |            |   |                      |        |            |
| n |   |            |   |                      |        |            |
| t |   |            |   |                      |        |            |
| i |   |            |   |                      |        |            |
| n |   |            |   |                      |        |            |
| u |   |            |   |                      |        |            |
| e |   |            |   |                      |        |            |
| d |   |            |   |                      |        |            |
| ) |   |            |   |                      |        |            |
| * |   |            |   |                      |        |            |
+---+---+------------+---+----------------------+--------+------------+
| a |   | b\.        |   | c\.                  | d\.    |            |
| \ |   |            |   |                      |        |            |
| . |   |            |   |                      |        |            |
+---+---+------------+---+----------------------+--------+------------+
| A | S | ACTIVITY   |   | ABSORBED DOSE        | TOTAL  |            |
| G | E | OF         |   |                      | DOSE\  |            |
| E | X | R          |   | PER SINGLE           | PER    |            |
|   |   | ADIOACTIVE |   | ADMINISTRATION       | ORGAN  |            |
|   |   |            |   |                      | / PER  |            |
|   |   | STUDY      |   | *(for each           | YEAR   |            |
|   |   | DRUG(S)    |   | radioactive study    |        |            |
|   |   |            |   | drug)*               |        |            |
|   |   | AD         |   |                      |        |            |
|   |   | MINISTERED |   |                      |        |            |
|   |   | AND OTHER  |   |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   | ASSOCIATED |   |                      |        |            |
|   |   | PROCEDURES |   |                      |        |            |
+---+---+------------+---+----------------------+--------+------------+
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+---+---+------------+---+----------------------+--------+------------+
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| E |   |            |   |                      |        |            |
| v |   |            |   |                      |        |            |
| a |   |            |   |                      |        |            |
| l |   |            |   |                      |        |            |
| u |   |            |   |                      |        |            |
| a |   |            |   |                      |        |            |
| t |   |            |   |                      |        |            |
| i |   |            |   |                      |        |            |
| o |   |            |   |                      |        |            |
| n |   |            |   |                      |        |            |
| a |   |            |   |                      |        |            |
| n |   |            |   |                      |        |            |
| d |   |            |   |                      |        |            |
| R |   |            |   |                      |        |            |
| e |   |            |   |                      |        |            |
| s |   |            |   |                      |        |            |
| e |   |            |   |                      |        |            |
| a |   |            |   |                      |        |            |
| r |   |            |   |                      |        |            |
| c |   |            |   |                      |        |            |
| h |   |            |   |                      |        |            |
|   |   |            |   |                      |        |            |
| O |   |            |   |                      |        |            |
| f |   |            |   |                      |        |            |
| f |   |            |   |                      |        |            |
| i |   |            |   |                      |        |            |
| c |   |            |   |                      |        |            |
| e |   |            |   |                      |        |            |
| o |   |            |   |                      |        |            |
| f |   |            |   |                      |        |            |
| O |   |            |   |                      |        |            |
| n |   |            |   |                      |        |            |
| c |   |            |   |                      |        |            |
| o |   |            |   |                      |        |            |
| l |   |            |   |                      |        |            |
| o |   |            |   |                      |        |            |
| g |   |            |   |                      |        |            |
| y |   |            |   |                      |        |            |
| D |   |            |   |                      |        |            |
| r |   |            |   |                      |        |            |
| u |   |            |   |                      |        |            |
| g |   |            |   |                      |        |            |
| P |   |            |   |                      |        |            |
| r |   |            |   |                      |        |            |
| o |   |            |   |                      |        |            |
| d |   |            |   |                      |        |            |
| u |   |            |   |                      |        |            |
| c |   |            |   |                      |        |            |
| t |   |            |   |                      |        |            |
| s |   |            |   |                      |        |            |
|   |   |            |   |                      |        |            |
| 5 |   |            |   |                      |        |            |
| 9 |   |            |   |                      |        |            |
| 0 |   |            |   |                      |        |            |
| 1 |   |            |   |                      |        |            |
| - |   |            |   |                      |        |            |
| B |   |            |   |                      |        |            |
| A |   |            |   |                      |        |            |
| m |   |            |   |                      |        |            |
| m |   |            |   |                      |        |            |
| e |   |            |   |                      |        |            |
| n |   |            |   |                      |        |            |
| d |   |            |   |                      |        |            |
| a |   |            |   |                      |        |            |
| l |   |            |   |                      |        |            |
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| a |   |            |   |                      |        |            |
| d |   |            |   |                      |        |            |
|   |   |            |   |                      |        |            |
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| l |   |            |   |                      |        |            |
| t |   |            |   |                      |        |            |
| s |   |            |   |                      |        |            |
| v |   |            |   |                      |        |            |
| i |   |            |   |                      |        |            |
| l |   |            |   |                      |        |            |
| l |   |            |   |                      |        |            |
| e |   |            |   |                      |        |            |
| , |   |            |   |                      |        |            |
| M |   |            |   |                      |        |            |
| D |   |            |   |                      |        |            |
| 2 |   |            |   |                      |        |            |
| 0 |   |            |   |                      |        |            |
| 7 |   |            |   |                      |        |            |
| 0 |   |            |   |                      |        |            |
| 5 |   |            |   |                      |        |            |
| - |   |            |   |                      |        |            |
| 1 |   |            |   |                      |        |            |
| 2 |   |            |   |                      |        |            |
| 6 |   |            |   |                      |        |            |
| 6 |   |            |   |                      |        |            |
|   |   |            |   |                      |        |            |
| A |   |            |   |                      |        |            |
| t |   |            |   |                      |        |            |
| t |   |            |   |                      |        |            |
| e |   |            |   |                      |        |            |
| n |   |            |   |                      |        |            |
| t |   |            |   |                      |        |            |
| i |   |            |   |                      |        |            |
| o |   |            |   |                      |        |            |
| n |   |            |   |                      |        |            |
| : |   |            |   |                      |        |            |
| R |   |            |   |                      |        |            |
| D |   |            |   |                      |        |            |
| R |   |            |   |                      |        |            |
| C |   |            |   |                      |        |            |
+---+---+------------+---+----------------------+--------+------------+
|   |   |            | # |                      |        |            |
|   |   |            | # |                      |        |            |
|   |   |            | # |                      |        |            |
|   |   |            | # |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | T |                      |        |            |
|   |   |            | h |                      |        |            |
|   |   |            | e |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | u |                      |        |            |
|   |   |            | n |                      |        |            |
|   |   |            | d |                      |        |            |
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|   |   |            | r |                      |        |            |
|   |   |            | s |                      |        |            |
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|   |   |            | g |                      |        |            |
|   |   |            | n |                      |        |            |
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|   |   |            | d |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | c |                      |        |            |
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|   |   |            | r |                      |        |            |
|   |   |            | t |                      |        |            |
|   |   |            | i |                      |        |            |
|   |   |            | f |                      |        |            |
|   |   |            | y |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | t |                      |        |            |
|   |   |            | h |                      |        |            |
|   |   |            | a |                      |        |            |
|   |   |            | t |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | t |                      |        |            |
|   |   |            | h |                      |        |            |
|   |   |            | e |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | s |                      |        |            |
|   |   |            | t |                      |        |            |
|   |   |            | u |                      |        |            |
|   |   |            | d |                      |        |            |
|   |   |            | y |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | o |                      |        |            |
|   |   |            | u |                      |        |            |
|   |   |            | t |                      |        |            |
|   |   |            | l |                      |        |            |
|   |   |            | i |                      |        |            |
|   |   |            | n |                      |        |            |
|   |   |            | e |                      |        |            |
|   |   |            | d |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | a |                      |        |            |
|   |   |            | b |                      |        |            |
|   |   |            | o |                      |        |            |
|   |   |            | v |                      |        |            |
|   |   |            | e |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | c |                      |        |            |
|   |   |            | o |                      |        |            |
|   |   |            | m |                      |        |            |
|   |   |            | p |                      |        |            |
|   |   |            | l |                      |        |            |
|   |   |            | i |                      |        |            |
|   |   |            | e |                      |        |            |
|   |   |            | s |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | w |                      |        |            |
|   |   |            | i |                      |        |            |
|   |   |            | t |                      |        |            |
|   |   |            | h |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | T |                      |        |            |
|   |   |            | i |                      |        |            |
|   |   |            | t |                      |        |            |
|   |   |            | l |                      |        |            |
|   |   |            | e |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | 2 |                      |        |            |
|   |   |            | 1 |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | C |                      |        |            |
|   |   |            | F |                      |        |            |
|   |   |            | R |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | S |                      |        |            |
|   |   |            | e |                      |        |            |
|   |   |            | c |                      |        |            |
|   |   |            | t |                      |        |            |
|   |   |            | i |                      |        |            |
|   |   |            | o |                      |        |            |
|   |   |            | n |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | 3 |                      |        |            |
|   |   |            | 6 |                      |        |            |
|   |   |            | 1 |                      |        |            |
|   |   |            | . |                      |        |            |
|   |   |            | 1 |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | a |                      |        |            |
|   |   |            | n |                      |        |            |
|   |   |            | d |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | t |                      |        |            |
|   |   |            | h |                      |        |            |
|   |   |            | a |                      |        |            |
|   |   |            | t |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | t |                      |        |            |
|   |   |            | h |                      |        |            |
|   |   |            | e |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | r |                      |        |            |
|   |   |            | e |                      |        |            |
|   |   |            | s |                      |        |            |
|   |   |            | p |                      |        |            |
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|   |   |            | n |                      |        |            |
|   |   |            | s |                      |        |            |
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|   |   |            | s |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | a |                      |        |            |
|   |   |            | r |                      |        |            |
|   |   |            | e |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | t |                      |        |            |
|   |   |            | r |                      |        |            |
|   |   |            | u |                      |        |            |
|   |   |            | e |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | a |                      |        |            |
|   |   |            | n |                      |        |            |
|   |   |            | d |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | a |                      |        |            |
|   |   |            | c |                      |        |            |
|   |   |            | c |                      |        |            |
|   |   |            | u |                      |        |            |
|   |   |            | r |                      |        |            |
|   |   |            | a |                      |        |            |
|   |   |            | t |                      |        |            |
|   |   |            | e |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | a |                      |        |            |
|   |   |            | s |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | o |                      |        |            |
|   |   |            | u |                      |        |            |
|   |   |            | t |                      |        |            |
|   |   |            | l |                      |        |            |
|   |   |            | i |                      |        |            |
|   |   |            | n |                      |        |            |
|   |   |            | e |                      |        |            |
|   |   |            | d |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | a |                      |        |            |
|   |   |            | b |                      |        |            |
|   |   |            | o |                      |        |            |
|   |   |            | v |                      |        |            |
|   |   |            | e |                      |        |            |
|   |   |            | . |                      |        |            |
+---+---+------------+---+----------------------+--------+------------+
|   |   |            | # |                      |        | #### DATE  |
|   |   |            | # |                      |        |            |
|   |   |            | # |                      |        |            |
|   |   |            | # |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | S |                      |        |            |
|   |   |            | I |                      |        |            |
|   |   |            | G |                      |        |            |
|   |   |            | N |                      |        |            |
|   |   |            | A |                      |        |            |
|   |   |            | T |                      |        |            |
|   |   |            | U |                      |        |            |
|   |   |            | R |                      |        |            |
|   |   |            | E |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | O |                      |        |            |
|   |   |            | F |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | I |                      |        |            |
|   |   |            | N |                      |        |            |
|   |   |            | V |                      |        |            |
|   |   |            | E |                      |        |            |
|   |   |            | S |                      |        |            |
|   |   |            | T |                      |        |            |
|   |   |            | I |                      |        |            |
|   |   |            | G |                      |        |            |
|   |   |            | A |                      |        |            |
|   |   |            | T |                      |        |            |
|   |   |            | O |                      |        |            |
|   |   |            | R |                      |        |            |
+---+---+------------+---+----------------------+--------+------------+
|   |   |            | # |                      |        | #### DATE  |
|   |   |            | # |                      |        |            |
|   |   |            | # |                      |        |            |
|   |   |            | # |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | S |                      |        |            |
|   |   |            | I |                      |        |            |
|   |   |            | G |                      |        |            |
|   |   |            | N |                      |        |            |
|   |   |            | A |                      |        |            |
|   |   |            | T |                      |        |            |
|   |   |            | U |                      |        |            |
|   |   |            | R |                      |        |            |
|   |   |            | E |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | O |                      |        |            |
|   |   |            | F |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | C |                      |        |            |
|   |   |            | H |                      |        |            |
|   |   |            | A |                      |        |            |
|   |   |            | I |                      |        |            |
|   |   |            | R |                      |        |            |
|   |   |            | P |                      |        |            |
|   |   |            | E |                      |        |            |
|   |   |            | R |                      |        |            |
|   |   |            | S |                      |        |            |
|   |   |            | O |                      |        |            |
|   |   |            | N |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | O |                      |        |            |
|   |   |            | F |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | R |                      |        |            |
|   |   |            | A |                      |        |            |
|   |   |            | D |                      |        |            |
|   |   |            | I |                      |        |            |
|   |   |            | O |                      |        |            |
|   |   |            | A |                      |        |            |
|   |   |            | C |                      |        |            |
|   |   |            | T |                      |        |            |
|   |   |            | I |                      |        |            |
|   |   |            | V |                      |        |            |
|   |   |            | E |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | D |                      |        |            |
|   |   |            | R |                      |        |            |
|   |   |            | U |                      |        |            |
|   |   |            | G |                      |        |            |
|   |   |            |   |                      |        |            |
|   |   |            | R |                      |        |            |
|   |   |            | E |                      |        |            |
|   |   |            | S |                      |        |            |
|   |   |            | E |                      |        |            |
|   |   |            | A |                      |        |            |
|   |   |            | R |                      |        |            |
|   |   |            | C |                      |        |            |
|   |   |            | H |                      |        |            |
|   |   |            | C |                      |        |            |
|   |   |            | O |                      |        |            |
|   |   |            | M |                      |        |            |
|   |   |            | M |                      |        |            |
|   |   |            | I |                      |        |            |
|   |   |            | T |                      |        |            |
|   |   |            | T |                      |        |            |
|   |   |            | E |                      |        |            |
|   |   |            | E |                      |        |            |
+---+---+------------+---+----------------------+--------+------------+

+-----------------------------------------------------------------------+
| Instructions for Completing Radioactive Drug Research Committee       |
| (RDRC)\                                                               |
| Report on Research Use of Radioactive Drugs \-- Study Summary\        |
| (Form FDA 2915)                                                       |
|                                                                       |
| > 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 2915                           |
| >                                                                     |
| > (Study Summary) for the following RDRC submissions:                 |
| >                                                                     |
| > 1\. **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.                                         |
| >                                                                     |
| > 2\. **Special Summary** (requirement -- 21 CFR 361.1 (c)(3)         |
| > Reports)                                                            |
| >                                                                     |
| > A special summary must be submitted to FDA at the time the RDRC     |
| > approves research studies involving                                 |
| >                                                                     |
| > more than 30 subjects or involving subjects under the age of 18. A  |
| > special summary consists of the                                     |
| >                                                                     |
| > submission of Form FDA 2915 (Study Summary) and a justification for |
| > the number of subjects or the                                       |
| >                                                                     |
| > inclusion of subjects under 18 years of age. In addition, provide   |
| > the maximum radiation dose commitment for                           |
| >                                                                     |
| > the organs listed in 21CFR361.1(b)(3)(i) for a representative       |
| > subject.                                                            |
| >                                                                     |
| > **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 begin on the     |
| > next page.*                                                         |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| #### SPECIFIC INSTRUCTIONS FOR FILLING OUT FORM FDA 2915              |
|                                                                       |
| > *(Titles and numbers, when used, correspond to the item blocks on   |
| > Form FDA 2915)*                                                     |
|                                                                       |
| ***When completing this form, and not enough space is provided for    |
| reporting in a section, attach a separate***                          |
|                                                                       |
| ***sheet with each information reporting section appropriately        |
| identified.***                                                        |
|                                                                       |
| > **Section A. General Information**                                  |
|                                                                       |
| 1.  **Type of Report** -- Check the appropriate box indicating        |
|     whether this is a special summary or an annual report. If this is |
|     a special summary, provide a justification for the need to study  |
|     more than 30 subjects\                                            |
|     or to study subjects under the age of 18. Studies involving       |
|     minors must be supported with review by a qualified pediatric     |
|     consultant to the RDRC and documented in the special summary.     |
|                                                                       |
| 2.  **RDRC Committee Number** -- Provide the committee number         |
|     assigned by FDA when the RDRC was initially approved.             |
|                                                                       |
| 3.  **Name of Institution** -- Provide the name of the medical        |
|     institution to which the RDRC is affiliated.                      |
|                                                                       |
| 4.  **Name and Address of IRB** -- Provide the name and address of    |
|     the Institutional Review Board (IRB)\                             |
|     that approved the study protocol.                                 |
|                                                                       |
| > **Section B. Specific Information**                                 |
| >                                                                     |
| > 1\. **Research Project** -- Check the appropriate box indicating    |
| > whether this is a special summary or an\                            |
| > annual report. If this is a special summary, provide a              |
| > justification for the need to study more than 30 subjects or to     |
| > study subjects under the age of 18. Studies involving minors must   |
| > be supported with\                                                  |
| > review by a qualified pediatric consultant to the RDRC and          |
| > documented in the special summary.                                  |
| >                                                                     |
| > a\. *Title of Research Project* -- Provide a unique and brief title |
| > of the research protocol that includes the name of the radioactive  |
| > drug^1^.                                                            |
| >                                                                     |
| > b\. *Study ID Number --* Provide the unique number assigned to the  |
| > research protocol by the Institution or RDRC for tracking purposes. |
| > A study ID number ***must*** be provided.                           |
| >                                                                     |
| > c\. *Original Study Approval Date* -- Provide the date the research |
| > protocol was approved by the\                                       |
| > RDRC for the first time.                                            |
| >                                                                     |
| > d\. *Study Termination Date* -- Provide the date the research       |
| > protocol was completed or terminated.                               |
| >                                                                     |
| > 2\. **Concise and Complete Description of the Research Project** -- |
| > Self-explanatory.                                                   |
|                                                                       |
| 2.  **Name of Responsible Investigator --** Provide the name of the   |
|     Principal Investigator and the name of\                           |
|     the prescribing physician, if other than the Principal            |
|     Investigator.                                                     |
|                                                                       |
| > 4\. **Pharmacological Dose** -- This is the mass dose of the        |
| > nonradioactive drug to be investigated that will\                   |
| > not cause a clinically detectable pharmacologic effect in humans.   |
| > Please cite relevant published literature or other valid human      |
| > studies supporting the use of this dose. If necessary, attach a     |
| > separate sheet.                                                     |
| >                                                                     |
| > a\. *Name of the Nonradioactive Drug* -- Provide the name of the    |
| > nonradioactive drug being\                                          |
| > investigated. The use of the term \"drug\" in this section is       |
| > synonymous with the terms moiety,\                                  |
| > active ingredient, compound, or ligand.                             |
| >                                                                     |
| > b\. *Mass Dose*                                                     |
| >                                                                     |
| > b.1. *Maximum mass dose* -- This is the maximum amount of           |
| > nonradioactive drug administered per\                               |
| > subject per single dose at the expiration time of the radiolabeled  |
| > drug to be administered. Indicate amount in terms of mass or weight |
| > expressed in units of µg or mg only.                                |
| >                                                                     |
| > b.2. *No observed effect level (NOEL) mass dose* -- This is the     |
| > pharmacologic dose of the\                                          |
| > nonradioactive drug that will not cause a clinically detectable     |
| > pharmacologic effect in humans.\                                    |
| > This is not necessarily the administered dose.                      |
|                                                                       |
| c.  *Maximum number of doses per subject* -- Specify the number of    |
|     administrations of the radioactive drug a research subject may    |
|     receive per year and the total number of doses specified in the   |
|     protocol.                                                         |
|                                                                       |
| > c.1 \-- *Maximum number of doses per subject per year*              |
| >                                                                     |
| > c.2 \-- *Maximum number of doses per subject per protocol*          |
| >                                                                     |
| > d\. *Route of administration* -- Indicate the route of              |
| > administration (e.g. I.V., P.O., etc.).                             |
| >                                                                     |
| > e\. *If the drug is under an IND, list IND Number* -- If the        |
| > radioactive drug or the nonradioactive drug is being investigated   |
| > under an Investigational New Drug Application (IND), identify the   |
| > IND number.                                                         |
| >                                                                     |
| > 5\. **List the radionuclides with the associated drug and identify  |
| > and quantitate the maximum\                                         |
| > radionuclide contaminants in the administered radioactive drug upon |
| > expiration.** --\                                                   |
| > Self-explanatory.                                                   |
| >                                                                     |
| > ^1.^ The term \"radioactive drug\" is defined in 21 CFR 310.3(n)    |
| > and includes a \"radioactive biological product\" as defined in 21\ |
| > CFR 600.3(ee).                                                      |
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| > **FILLING OUT FORM FDA 2915** *(Continued)*                         |
| >                                                                     |
| > **Section B. Specific Information** *(Continued)*                   |
| >                                                                     |
| > 6\. **Radiation Absorbed Dose**                                     |
|                                                                       |
| -   All study summaries should list the specific reference(s) that    |
|     were used to estimate the dose commitments (e.g., ICRP            |
|     Publication 80 Table 3.2.1). For those radioactive drugs for      |
|     which no reference(s) are available, list your assumptions and    |
|     show your calculations. The report should\                        |
|     include the dose contribution from the administered radioactive   |
|     study drug and any other\                                         |
|     associated procedures (i.e., would not have occurred but for the  |
|     study) contributing to the radiation absorbed dose.               |
|                                                                       |
| -   For a **special summary**, provide the maximum radiation dose     |
|     commitment to the whole body, the critical organ, and each organ  |
|     as specified in 21 CFR 361.1(b)(3)(i) received by a               |
|     *representative* subject.                                         |
|                                                                       |
| -   For an **annual report**, provide the radiation dose commitment   |
|     to the whole body, the critical\                                  |
|     organ, and each organ as specified in 21 CFR361.1(b)(3)(i)        |
|     received by *each* subject receiving the radioactive study drug   |
|     during the reporting calendar year. For each subject, provide (a) |
|     Age and\                                                          |
|     Sex; (b) the amount of radioactivity administered for each        |
|     radioactive study drug used; (c)\                                 |
|     the absorbed dose to the whole body, the critical organ, and each |
|     organ specified in 21 CFR 361.1(b)(3)(i) per single               |
|     administration for each radioactive study drug and other          |
|     procedures associated\                                            |
|     with the study; and (d) the resultant cumulative radiation dose   |
|     to the subject for the whole body\                                |
|     and organs referenced above within the calendar year.             |
|                                                                       |
| a.  *Age and Sex* -- Specify the age and sex for each individual      |
|     research subject studied.                                         |
|                                                                       |
| b.  *Activity of Radioactive Study Drug(s) Administered and Other     |
|     Associated Procedures* -- For each individual research subject    |
|     identified in column a, provide the amount of radioactivity       |
|     administered along with the name of each radioactive study drug   |
|     received. Express each amount of radioactivity in MBq, µCi, or    |
|     mCi. FDA prefers you use the International System of Units (SI).  |
|     Note: 37 MBq =1mCi.                                               |
|                                                                       |
| > For other associated procedures (i.e., would not have occurred but  |
| > for the study), identify the sources of radiation.                  |
|                                                                       |
| c.  *Absorbed Dose per Single Administration* -- Provide theradiation |
|     absorbed dose in mSv \[1mSv =\                                    |
|     100 mrem\] for each target organ, e.g. whole body, lens of eye,   |
|     gonads, and critical organ(s).                                    |
|                                                                       |
| d.  *Total Dose Per Organ/Per Year* -- Provide the total cumulative   |
|     radiation dose from the radioactive study drug(s) and associated  |
|     procedures received per organ for a 12-month period of time,      |
|     usually a calendar year, unless otherwise specified.              |
|                                                                       |
| e.  *Number of Research Subjects Studied this Reporting Year* --      |
|     Self-explanatory.                                                 |
|                                                                       |
| f.  *Number of Research Subjects Studied this Reporting Year Under 18 |
|     years of Age* --*\                                                |
|     *Self-explanatory.                                                |
|                                                                       |
| g.  *Cumulative Number of Research Subjects Studied from Initiation   |
|     of this Protocol Through End of this Report* -- Self-explanatory. |
|                                                                       |
| h.  *Total Number of Research Subjects for Which this Protocol is     |
|     Approved* -- Self-explanatory.                                    |
|                                                                       |
| > 7\. **Claim of Confidentiality** -- Indicate whether or not you are |
| > claiming confidentiality. If confidentiality is claimed, attach a   |
| > justification demonstrating that this report constitutes a trade    |
| > secret or confidential information as defined in 21 CFR 20.61.      |
| >                                                                     |
| > 8\. **Certification** -- The Principal Investigator and the RDRC    |
| > chairperson must sign the form. Indicate the date(s) the form is    |
| > signed by the Principal Investigator and by the RDRC chairperson.   |
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