90 FR 83 pgs. 18685-18686 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators
Type: NOTICEVolume: 90Number: 83Pages: 18685 - 18686
Pages: 18685, 18686Docket number: [Docket No. FDA-2024-N-4754]
FR document: [FR Doc. 2025-07577 Filed 4-30-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4754]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DATES:
Submit written comments (including recommendations) on the collection of information by June 2, 2025.
ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting "Currently under Review-Open for Public Comments" or by using the search function. The OMB control number for this information collection is 0910-0396. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Financial Disclosure by Clinical Investigators
OMB Control Number 0910-0396-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.
| 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) | 3,401 | 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.
[top] 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
In the Federal Register of November 29, 2024 (89 FR 94735), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received but was not PRA related.
FDA estimates the burden of this collection of information as follows:
| 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.
| 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.
| 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. | |||||
The burden for this information collection request has changed since the last OMB approval. We have adjusted our estimated burden for the information collection to reflect the number of submissions we received in the last few years. These adjustments result in an increase of 557 total annual responses and a corresponding increase of 87 total hours.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07577 Filed 4-30-25; 8:45 am]
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