[Federal Register: February 10, 2006 (Volume 71, Number 28)]
[Notices]
[Page 7051-7052]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10fe06-84]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0296]
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 March
13, 2006.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
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. FDA has said that it has no preference as to how this
information is collected from investigators and that sponsors/
applicants have the flexibility to collect the information in the most
efficient and least burdensome manner that will be effective. FDA
estimated that the total reporting costs of sponsors would be less than
$450,000 annually. Costs could also occur after a marketing application
is submitted if FDA determines that the financial interests of an
investigator raise significant questions about the integrity of the
data.
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 Total Annual
21 CFR Section Respondents per Response Responses Hours Per Response Total Hours
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54.4(a)(1) and 1,000 1 1,000 5 5,000
(a)(2)
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54.4(a)(3) 100 1 100 20 2,000
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54.4 46,000 .25 11,500 .1 11,500
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Total .............. ................. .................... .................... 18,500
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\1\There are no capital cost or operating and maintenance costs associated with this collection of information.
[[Page 7052]]
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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21 CFR No. of Annual Frequency per Hours Per
Section Recordkeepers Recordkeeping Total Annual Records Recordkeeper 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.
In the Federal Register of August 25, 2005 (70 FR 49928), FDA
announced the availability of the draft guidance and requested comments
for 60 days on the information collection. No comments were received
regarding this information collection.
Dated: February 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1807 Filed 2-9-06; 8:45 am]
BILLING CODE 4160-01-S