[Federal Register: July 25, 2001 (Volume 66, Number 143)]
[Notices]
[Page 38712-38713]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy01-112]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N- 0308]
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 September 24, 2001.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
Submit written comments on the collection of information to the Dockets
Management Branch (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: JonnaLynn P. Capezzuto, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.
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: (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 No. 0910-
0369)--Extension
Respondents are sponsors of marketing applications that contain
clinical data from studies covered by the regulation. 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 estimates that the total reporting costs of sponsors will 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
21 CFR Section No. of Respondents Response Total Annual Responses Hours per Response Total Hours
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54.4(a)(1) and (a)(2) 1,000 1 1,000 1 1,000
54.4(a)(3) 100 1 100 4 400
54.4 46,000 1 46,000 .10 4,600
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Total 6,000
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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
[[Page 38713]]
application. 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 Recordkeeper Total Hours
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54.6 1,000 1 1,000 .25 250
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 19, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-18479 Filed 7-24-01; 8:45 am]
BILLING CODE 4160-01-S