Federal Register - February 16, 2021
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Source: Federal Register
9511
Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices comment on the proposed collection of information. No comments were received and we have therefore made no
adjustments to our estimate, which is as follows:
TABLE 1ESTIMATED ANNUAL REPORTING BURDEN
Number of responses per respondent
Number of respondents
21 CFR section
Average burden per response in hours
Total annual responses
Total hours
Subpart B
314.50alContent and format of a 505b1 or 505b2 application
314.50i1patent certifications:
Form FDA 3542
Form FDA 3542a
314.50i6 amended patent certifications
314.52a, b, and eNDAsnotice of noninfringement of patent certification
314.52cNoninfringement of patent certification notice content
314.53f1Correction of patent information errors by persons other than the NDA holder
314.53f2Correction of patent information errors by the NDA holder
314.60Amendments to unapproved NDA, supplement or resubmission
314.60fpatent certifications for unapproved applications
314.65Withdrawal of unapproved applications
314.70 and 314.71Supplements and other changes to approved application
314.72Changes of ownership of NDAs
314.81Other postmarketing reports 314.81b1 3331
and 3331a field alert reports and followups
314.81b22252Annual reports
314.81b22253Promotional labeling
121
1.15
139
1,921
267,019
281
310
17
2.875
2.084
1
808
646
17
10
15
2
8,080
9,690
34
15
3
45
15
675
22
3
66
0.33 20
minutes
22
24
1
24
10
240
28
1.4
39
1
39
256
8.23
2,106
80
168,480
6
14
1
1.21
6
17
2
2
12
34
492
67
6.57
1.45
3,232
97
150
2
484,800
194
484
626
331
20.3
4.9
141.3
9,834
3,066
46,782
8
40
2
78,672
122,640
93,564
Subpart C
314.94aanddANDA content
314.94a12viii amended patent certifications before approval of ANDA
314.95cNon-infringement of patents ANDAs
229
4.3
987
480
473,760
153
400
1
3
153
1,200
306
400
314.96a1Amendments to unapproved ANDAs
314.96c amendment for pharmaceutical equivalent to a listed drug other than RLD
314.96dpatent certification requirements
314.97Supplements and other changes to ANDAs
314.97b Supplements to ANDA for pharmaceutical equivalent to a listed drug other than RLD
314.99aANDA Applicants: Withdrawal of unapproved ANDAs
314.99aANDA Transfer of ownership
451
36.2
16,311
2
0.33 20
minutes 80
1,304,880
1
100
361
1
1
22.8
1
100
8,237
300
2
80
300
200
658,960
1
1
1
300
300
77
135
2.3
1.24
177
167
2
2
354
334
khammond on DSKJM1Z7X2PROD with NOTICES
Subpart D
314.101aNDA or ANDA filing over protest
1
1
1
0.5 30
minutes
0.5
314.107enotification of court actions or written consent to approval
247
2
494
0.5 30
minutes
247
Subparts G, H, and I
314.420drug master files FDA 3938original amendments
DMFstechnical, administrative, REMS
DMFsannual reports
314.550Promotional material and subpart H applications
36
2,946
2,946
55
27.2
11.4
3.33
11.6
981
33,590
9,834
640
61
8
4
120
59,841
268,720
39,336
76,800
Total
4,118,933.5
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