Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators
Federal Register, Volume 80 Issue 209 (Thursday, October 29, 2015)
Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)
Notices
Pages 66542-66543
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2015-27559
Page 66542
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2012-N-0280
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.
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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: Fax written comments on the collection of information by November 30, 2015.
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0396. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, 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.
Under Sec. 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 Sec. 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).
Under Sec. 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 a time period of 2 years after the date of approval of the applications. Sponsors of covered studies maintain many records with regard to clinical investigators, including protocol agreements and investigator reacutesumeacutes 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.
Under Sec. 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 it will take clinical investigators 15 minutes to submit such records to the sponsor.
In the Federal Register of April 29, 2015 (80 FR 23803), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although two comments were received, none were responsive to the four collection of information topics solicited and therefore will not be discussed in this document.
FDA estimates the burden of this collection of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
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Certification--54.4(a)(1) and 1,000 1 1,000 1 1,000
(a)(2)--Form FDA 3454..........
Disclosure--54.4(a)(3)--Form FDA 100 1 100 5 500
3455...........................
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Total....................... .............. .............. .............. .............. 1,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Number of records Total annual
21 CFR Section recordkeepers per recordkeeper records Average burden per recordkeeping Total hours
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Recordkeeping--54.6...................... 1,000 1 1,000 0.25 250
(15 minutes).....................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Page 66543
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
21 CFR Section Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
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54.4(b)--Clinical Investigators................ 7,106 1 7,106 0.17 1,208
(10 minutes)...........................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
FR Doc. 2015-27559 Filed 10-28-15; 8:45 am
BILLING CODE 4164-01-P
