Application for Food and Drug Administration Approval to Market a New Drug
OMB Control Number 0910-0001
CHANGE REQUEST (83-C)
Date: February 24, 2015
Now that the January 16, 2009 (74 FR 2849) final rule has been fully implemented, we are already capturing the data in the “Total Annual Responses” column when we update these estimates from CDER’s Document Archiving, Reporting & Regulatory Tracking System for 21 CFR 314 (0910-0001), (§§ 314.94(a)(7)(i), 314.96(a)(1), and 314.97), and it would be duplicative to also maintain the same data under 0910-0630.
Table 1-- Estimated Annual Reporting Burden
21 CFR Section |
No. of Respondents |
No of Responses per Respondent |
Total Annual Responses |
Average Burden per Response |
Total Hours |
314.94(a)(7) |
84 |
1 |
84 |
72 |
6,048 |
314.96(a)(1) |
1 |
1 |
1 |
72 |
72 |
314.97 |
1 |
1 |
1 |
72 |
72 |
TOTAL |
|
|
|
|
6,192 |
|
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| File Type | application/msword |
| Author | Quiros, Simonne M |
| Last Modified By | Mizrachi, Ila |
| File Modified | 2015-02-24 |
| File Created | 2015-02-19 |