[Federal Register Volume 73, Number 249 (Monday, December 29, 2008)]
[Notices]
[Pages 79493-79495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30837]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0637]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information requiring the
sponsor of any drug, biologic, or device marketing application to
certify to the absence of clinical investigators and/or disclose those
financial interests as required, when covered clinical studies are
submitted to FDA in support of product marketing.
DATES: Submit written or electronic comments on the collection of
information by February 27, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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.
[[Page 79494]]
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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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Annual Frequency per Total Annual Hours per
21 CFR Section No. of Respondents Response Responses 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 0.25 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.
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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Annual Frequency per Total Annual Hours per
21 CFR Section No. of Recordkeepers Recordkeeping Records Record Total Hours
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54.6 1,000 1 1,000 0.25 250
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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.
[[Page 79495]]
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
Dated: December 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30837 Filed 12-24-08; 8:45 am]
BILLING CODE 4160-01-S