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  
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