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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Batch Production and Control Records - 212.20(c) and (e); 212.50(a) and (b)
Modified
221
4420
0
Batch Production and Control Records - 212.20(d) and (e); 212.50(c); 212.80(c)
New
64629
64629
0
Complaints - 212.100(b) and (c)
New
129
65
0
Complaints - 212.20(c); 212.100(a)
New
129
129
0
Conditional Final Releases - 212.70(f)
New
129
129
0
Distribution Records - 212.20(c); 212.90(a)
New
129
129
0
Distribution Records - 212.90(b)
New
64629
16157
0
Equipment and Facilities Records - 212.20(c); 212.30(b); 212.50(d); 212.60(f)
New
1935
1935
0
Equipment and Facilities Records - 212.30(b); 212.50(d); 212.60(f)
New
484782
38783
0
Laboratory Testing Records - 212.20(c); 212.60(a) and (b); 212.61(a); 212.70(a), (b), and (d)
New
3225
3225
0
Laboratory Testing Records - 212.60(g); 212.61(b); 212.70(d)(2) and (d)(3)
New
64629
10341
0
Out-of-Specification Investigations - 212.20(c); 212.71(a)
New
4644
4644
0
Out-of-Specification Investigations - 212.71(b)
New
129
129
0
Records of Components, Containers, and Closures - 212.20(c); 212.40(a) and (b)
New
258
258
0
Records of Components, Containers, and Closures - 212.40(e)
New
4644
2322
0
Reprocessing Procedures - 212.20(c); 212.71(d)
New
129
129
0
Sterility Test Failure Notices - 212.70(e)
New
32
32
0
Total burden requested under this ICR:
694402
147456
0
To view an IC, click on IC Title