[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Pages 43843-43844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18235]



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.


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 August 
27, 2012.

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 [email protected]. 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.

Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
[email protected].

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 
    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 
    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

[[Page 43844]]

regard to 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.
    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 
    Subsequent to publication of the 60-day notice, FDA reestimated the 
information collection. Upon additional inspection of the data, FDA has 
updated the estimated recordkeeping burden hours to more accurately 
reflect the burden.
    In the Federal Register of March 28, 2012 (77 FR 18826), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 

                                 Table 1--Estimated Annual Reporting Burden \1\
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
Certification--54.4(a)(1) and                902               1             902               1             902
 (a)(2)--Form FDA 3454..........
Disclosure--54.4(a)(3)--Form FDA              90               1              90               5             450
    Total.......................  ..............  ..............  ..............  ..............           1,352
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

                                                       Table 2--Estimated Annual Reporting Burden
                                                                                         Number of                      Average  burden
                           21 CFR Section                               Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
Recordkeeping--54.6................................................             902                1              902             0.25              226

                                                 Table 3--Estimated Annual Third-Party Disclosure Burden
                                                                                         Number of
                           21 CFR Section                               Number of     disclosures per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent      disclosures    per  disclosure
Clinical Investigators--54.4(b)....................................          10,554                1           10,554             0.17            1,794

    Dated: July 16, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18235 Filed 7-25-12; 8:45 am]