2024-28034. Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators

Table 1—Estimated Number of Applications, Clinical Trials, and Investigators Subject to the Regulation by Type of Application ¹

Application type	Total number of applications	Number of applications affected	Number of trials	Number of investigators
Drugs:
New drug application (NDA), new molecular entity (NME)	35	35	3 to 10	3 to 100.
NDA non-NME	94	44	3 to 10	3 to 100.
NDA efficacy supplement	171	100	1 to 3	10 to 30.
Abbreviated new drug application (ANDA)	685	1	1.1	2.
ANDA supplement	10,366	1	1	2.
CBER Biologics:
Biologics license application (BLA)	26	26	3 to 10	3 to 100.
BLA efficacy supplement	26	26	1 to 3	10 to 30.
CDER Biologics:
BLAs	19	19	3 to 10	3 to 100.
BLA efficacy supplements	64	50	1 to 3	10 to 30.
Medical Devices:
Premarket approval (PMA)	43	50	1 to 31	10 to 20.
PMA supplement	28	30	to 3	3 to 10.
Reclassification devices	0	0	0	0.
510(k)	3401	254	1	3 to 10.
De Novo requests	84	76	1 to 3	10 to 20.
1  Source: Agency estimates.

FDA estimates the burden of this collection of information as follows:

Reporting Burden

Under § 54.4(a) (21 CFR 54.4(a)), 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 § 54.4(a)(3), 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 § 54.4(a)(1) 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 § 54.4(a)(3), 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 2—Estimated Annual Reporting Burden ¹

21 CFR section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Certification—54.4(a)(1) and (2)—Form FDA 3454	712	1	712	1	712
Disclosure—54.4(a)(3)—Form FDA 3455	71	1	71	5	355
Total					1,067
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 compensation agreements with any compensation paid to nonemployee clinical investigators, including information showing any financial interests held by the clinical investigator, for 2 years after the date of approval of the applications. Sponsors of covered studies maintain many records regarding clinical investigators, including protocol agreements and investigator resumes or curriculum vitae. FDA estimates an average of 15 minutes will be required for each recordkeeper to add this record to the clinical investigators' file. ( print page 94738)

Table 3—Estimated Annual Recordkeeping Burden ¹

21 CFR section	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping	Total hours 2
Recordkeeping—54.6	712	1	712	0.25	178
1  There are no capital costs or operating and maintenance costs associated with this collection of information.
2  Numbers have been rounded.

Third-Party Disclosure Burden

Under § 54.4(b), clinical investigators supply to the sponsor of a covered study financial information sufficient to allow the sponsor to submit complete and accurate certification or disclosure statements. Clinical investigators are accustomed to supplying such information when applying for research grants. Also, most people know the financial holdings of their immediate family and records of such interests are generally accessible because they are needed for preparing tax records. For these reasons, FDA estimates that the time required for this task may range from 5 to 15 minutes; we used the median, 10 minutes, for the average burden per disclosure (see table 4). To estimate the number of respondents for each FDA Center, we took the median number of investigators for each application type, multiplied each median number of investigators by the number of affected applications for that application type, then summed those products to get the total number of respondents for the Center.

Table 4—Estimated Annual Third-Party Disclosure Burden ¹

21 CFR section	Number of respondents	Number of disclosures per respondent	Total annual disclosures	Average burden per disclosure	Total hours 2
54.4(b)—Clinical Investigators	13,646	1	13,646	0.17	2,320
1  There are no capital costs or operating and maintenance costs associated with this collection of information.
2  Numbers have been rounded.