
[Federal Register: April 22, 2009 (Volume 74, Number 76)]
[Notices]               
[Page 18385-18386]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ap09-55]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0637]

 
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 May 
22, 2009.

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: 202-395-6974, or e-mailed 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:  Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

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 are sponsors of marketing applications that contain 
clinical data from studies covered by the regulations. These sponsors 
represent pharmaceutical, biologic, and medical device firms. The 
applicant will incur reporting costs in order to comply with the final 
rule. Applicants will be required to submit, for example, the complete 
list of clinical investigators for each covered study, not employed by 
the applicant and/or sponsor of the covered study, and either certify 
to the absence of certain financial arrangements with clinical 
investigators or disclose the nature of those arrangements to FDA and 
the steps taken by the applicant or sponsor to minimize the potential 
for bias. The clinical investigator will have to supply information 
regarding financial interests or payments held in the sponsor of the 
covered study.
    In the Federal Register of December 29, 2008 (73 FR 79493), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. Two comments were received, one comment 
expressed support for this information collection. The second comment 
raised several issues, first, the issue of the current cost the 
commenter incurs in the collection of Financial Disclosure and the 
estimate of substantial operating costs the commenter incurs in 
operating costs to support the collection of investigator financial 
information. FDA appreciates the comment and based on this new data, 
submitted by the commenter, will undertake a new evaluation whether 
there are capital costs or operating and maintenance costs associated 
with this collection of information. FDA also appreciates the comment 
concerning the definition of ``clinical investigator'' and will forward 
the comment to the FDA office responsible for this collection of 
information to consider in any future rulemaking. However, these 
definitions are codified in 21 CFR 54.2.
    FDA also appreciates the comment regarding the use of Form FDA 1572 
to minimize burden. However, 21 CFR 54.4 requires the use of Form FDA 
3454 and Form FDA 3455. This comment will also be forwarded to the FDA 
office responsible for this collection of information to consider in 
any future rulemaking.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of       Annual Frequency per     Total Annual        Hours per
                    21 CFR Section                         Respondents           Response            Responses           Response         Total Hours
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54.4(a)(1) and (a)(2)--Form FDA 3454                                1,000                     1              1,000                  5              5,000
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54.4(a)(3)--Form FDA 3455                                             100                     1                100                 20              2,000
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54.4(b)                                                            46,000                   .25             11,500                  1             11,500
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Total                                                   .................  ....................  .................  .................             18,500
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 18386]]

    The sponsors of covered studies will be required to 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. This 
time is consistent with the current recordkeeping requirements for 
other information related to marketing applications for human drugs, 
biologics, and medical devices. Currently, sponsors of covered studies 
must maintain many records with 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 clinical investigators' file.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                              No. of       Annual Frequency per     Total Annual
                    21 CFR Section                        Recordkeepers        Recordkeeping          Records        Hours per Record     Total Hours
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54.6                                                                1,000                     1              1,000                .25                250
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Total                                                   .................  ....................  .................  .................                250
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: April 15, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9148 Filed 4-21-09; 8:45 am]

BILLING CODE 4160-01-S
