2021-26182. Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on “Financial Disclosure by Clinical Investigators.”

DATES:

Submit either electronic or written comments on the collection of information by January 31, 2022.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 31, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 31, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2012-N-0280 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

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, [e-mail].

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on 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 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.

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)	55	55	3 to 10	3 to 100
NDA non-NME	78	37	3 to 10	3 to 100
NDA efficacy supplement	196	119	1 to 3	10 to 30
Abbreviated new drug application (ANDA)	821	1	1.1	2
ANDA supplement	10,894	1	1	2
CBER Biologics:
Biologics license application (BLA)	10	10	3 to 10	3 to 100
BLA efficacy supplement	30	30	1 to 3	10 to 30
CDER Biologics:
BLAs	25	25	3 to 10	3 to 100
BLA efficacy supplements	102	65	1 to 3	10 to 30
Medical Devices:
Premarket approval (PMA)	39	39	1 to 31	10 to 20
PMA supplement	29	29	to 3	3 to 10
Reclassification devices	0	0	0	0
510(k)	3,947	247	1	3 to 10
De Novo requests	63	57	1 to 3	10 to 20
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	715	1	715	1	715
Disclosure—54.4(a)(3)—Form FDA 3455	72	1	72	5	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 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 than an average of 15 minutes will be required for each recordkeeper to add this record to the clinical investigators' file.

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	715	1	715	0.25	179
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 1).

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	13,082	1	13,082	0.17	2,224
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. Our estimated burden for the information collection reflects a 298 hour increase. We have adjusted our estimated burden for the information collection to reflect the number of submissions we received in the last few years. Additionally, for products regulated by the Center for Devices and Radiological Health, we now include De Novo requests as a type of application that may rely on clinical studies. For products regulated by the Center for Drug Evaluation and Research, we now include biologics license applications (BLAs) and BLA efficacy supplements that were inadvertently excluded from our last information collection request as a type of application.

Dated: November 24, 2021.

Lauren K. Roth,

Associate Commissioner for Policy.