[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