Document ID: FDA-2012-N-0280-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Financial
Disclosure by Clinical Investigators
Posted Date: 2015-10-29T04:00Z

[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 
r[eacute]sum[eacute]s 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...........................
                                 -------------------------------------------------------------------------------
    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