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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Financial Disclosure by Clinical Investigators OMB Control Number 09100396
Extension Respondents to this collection are sponsors of marketing applications that contain clinical data from studies covered by the regulations. These
sponsors represent pharmaceutical, biologic, and medical device firms.
Respondents are also clinical investigators who provide financial information to the sponsors of marketing applications.
Table 1 shows information that is the basis of the estimated number of respondents in tables 2 through 4.

TABLE 1ESTIMATED NUMBER OF APPLICATIONS, CLINICAL TRIALS, AND INVESTIGATORS SUBJECT TO THE REGULATION
BY TYPE OF APPLICATION 1
Total number of applications
Application type Drugs:
New drug application NDA, new molecular entity NME
NDA non-NME
NDA efficacy supplement
Abbreviated new drug application ANDA
ANDA supplement
CBER Biologics:
Biologics license application BLA
BLA efficacy supplement
CDER Biologics:
BLAs
BLA efficacy supplements
Medical Devices:
Premarket approval PMA
PMA supplement
Reclassification devices
510k
De Novo requests

Number of applications affected
Number of trials
Number of investigators
55
78
196
821
10,894

55
37
119
1 1

3 to 10
3 to 10
1 to 3
1.1
1

3 to 100
3 to 100
10 to 30
2 2

10
30

10
30

3 to 10
1 to 3

3 to 100
10 to 30

25
102

25
65

3 to 10
1 to 3

3 to 100
10 to 30

39
29
0 3,947
63

39
29
0 247
57

1 to 31
to 3
0
1
1 to 3

10 to 20
3 to 10
0 3 to 10
10 to 20

Source: Agency estimates.

FDA estimates the burden of this collection of information as follows:
Reporting Burden Under 54.4a 21 CFR 54.4a, applicants submitting an application that relies on clinical studies must submit a complete list of clinical investigators who participated in a covered clinical study, and must either certify to the absence of certain financial arrangements with clinical investigators Form FDA 3454 or, under 54.4a3, disclose to FDA the nature of those arrangements and the steps taken by the
applicant or sponsor to minimize the potential for bias Form FDA 3455.
FDA estimates that almost all applicants submit a certification statement under 54.4a1 and 2.
Preparation of the statement using Form FDA 3454 should require no more than 1 hour per study. The number of respondents is based on the estimated number of affected applications.
When certification is not possible and disclosure is made using Form FDA
3455, the applicant must describe, under 54.4a3, the financial arrangements or interests and the steps
that were taken to minimize the potential for bias in the affected study.
As the applicant would be fully aware of those arrangements and the steps taken to address them, describing them will be straightforward. The Agency estimates that it will take about 5 hours to prepare this narrative. Based on our experience with this collection, FDA
estimates that approximately 10 percent of the respondents with affected applications will submit disclosure statements.

TABLE 2ESTIMATED ANNUAL REPORTING BURDEN 1
Number of respondents
lotter on DSK11XQN23PROD with NOTICES1

21 CFR section
Number of responses per respondent
Total annual responses
Average burden per response
Total hours
Certification54.4a1 and 2Form FDA 3454
Disclosure54.4a3Form FDA 3455

715
72

1
1

715
72

1
5

715
360

Total

1,075

1 There
are no capital costs or operating and maintenance costs associated with this collection of information.

Recordkeeping Burden Under 54.6 21 CFR 54.6, the sponsors of covered studies must maintain complete records of
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compensation agreements with any compensation paid to nonemployee clinical investigators, including information showing any financial
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interests held by the clinical investigator, for 2 years after the date of approval of the applications. Sponsors of covered studies maintain many
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