Federal Register - February 18, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices protocol submissions subject to mandatory certification requirements under section 402j5B of the PHS
Act, is 12,989 for CDER plus 1,220 for CBER, or 14,209 submissions per year.
The minutes per response is the estimated number of minutes that a respondent would spend preparing the information to be submitted to FDA
under section 402j5B of the PHS
Act, including the time it takes to enter the necessary information on the form.
Based on its experience with current submissions, FDA estimates that approximately 15 minutes on average would be needed per response for certifications that accompany IND
applications and clinical protocol amendment submissions. It is assumed that most submissions to investigational applications will reference only a few protocols for which the sponsor/
applicant/submitter has obtained a NCT
number from https clinicaltrials.gov/
prior to making the submission to FDA.
It is also assumed that the sponsor/
applicant/submitter has electronic capabilities allowing them to retrieve
the information necessary to complete the form in an efficient manner.
Marketing Applications/Submissions.
In CY 2019, CDER and CBER received 252 new drug applications NDA/
biologics license applications BLA/
premarket approvals PMA/
resubmissions and 701 NDA/BLA
amendments for which certifications are needed. CDER and CBER received 295
efficacy supplements/resubmissions to previously approved NDAs/BLAs in CY
2019. CDER and CBER received 893
abbreviated new drug applications ANDAs in CY 2019. CDER received 765 bioequivalence amendments/
supplements in CY 2019. CDER and CBER anticipate that new drug/biologic applications/resubmissions and efficacy supplement submission rates will remain at or near this level in the near future.
FDAs Center for Devices and Radiological Health CDRH received a total of 324 new applications for PMA, 510k submissions containing clinical information, PMA supplements, applications for humanitarian device exemptions HDE and amendments in
10105
CY 2019. CDRH anticipates that application, amendment, supplement, and annual report submission rates will remain at or near this level in the near future.
Based on its experience reviewing NDAs, BLAs, PMAs, HDEs, 510ks, and ANDAs and experience with current submissions of Form FDA 3674, FDA
estimates that approximately 45 minutes on average would be needed per response for certifications which accompany NDA, BLA, PMA, HDE, 510k, and ANDA marketing applications and submissions. It is assumed that the sponsor/applicant/
submitter has electronic capabilities allowing them to retrieve the information necessary to complete the form in an efficient manner.
In the Federal Register of May 14, 2020 85 FR 28955, FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
FDA estimates the burden of this collection of information as follows:
TABLE 1ESTIMATED ANNUAL REPORTING BURDEN 1
Number of respondents investigational applications
FDA; center activity
Number of respondents marketing applications
Number of responses per respondent
Total annual responses
Average burden per response
Total hours
CDER
New Applications IND
Clinical Protocol Amendments IND
New Marketing Applications/Resubmissions NDA/BLA.
Clinical Amendments to Marketing Applications.
Efficacy Supplements/Resubmissions
Abbreviated New Drug Applications ANDAOriginal Applications.
ANDA Bioequivalence Supplements/Amendments.
1,661
11,328
220
1
1
1
1,661
11,328
220
0.25 15 minutes
0.25 15 minutes
0.75 45 minutes
415
2,832
165
701
1
701
0.75 45 minutes
526
257
892
1
1
257
892
0.75 45 minutes ..
0.75 45 minutes
193
669
765
1
765
0.75 45 minutes
573
639
581
32
1
1
1
639
581
32
0.25 15 minutes ..
0.25 15 minutes
0.75 45 minutes ..
160
145
24
0
1
0
0.75 45 minutes ..
0
38
1
38
0.75 45 minutes
28
1
1
1
0.75 45 minutes ..
1
0
1
0
0.75 45 minutes ..
0
324
1
324
0.75 45 minutes ..
243
5,974
CBER
jbell on DSKJLSW7X2PROD with NOTICES
New Applications IND
Clinical Protocol Amendments IND
New Marketing Applications/Resubmissions NDA/BLA/PMA.
Clinical Amendments to Marketing Applications.
Efficacy Supplements/Resubmissions BLA
only.
Abbreviated New Drug Applications ANDAOriginal Applications.
ANDA Bioequivalence Supplements/Amendments.
CDRH
New Marketing Applications includes PMAs, HDEs, Supplements and 510ks expected to contain clinical data.
Total
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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