[Federal Register Volume 71, Number 28 (Friday, February 10, 2006)]
[Notices]
[Pages 7051-7052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1807]


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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