[Federal Register Volume 66, Number 143 (Wednesday, July 25, 2001)]
[Notices]
[Pages 38712-38713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18479]


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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
                                                                                                                                       -----------------
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