[Federal Register: August 25, 2005 (Volume 70, Number 164)]
[Page 49928-49929]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0296]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Financial Disclosure by Clinical Investigators

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 October 24, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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: Karen L. Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

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 

    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 

[[Page 49929]]

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 
    FDA estimates the burden of this collection of information as 

                                 Table 1.--Estimated Annual Reporting Burden\1\
   21 CFR          No. of       Annual Frequency        Total Annual
   Section      Respondents       per Response           Responses          Hours Per Response     Total Hours
54.4(a)(1)             1,000                   1                  1,000                      5            5,000
 and (a)(2)
54.4(a)(3)               100                   1                    100                     20            2,000
54.4                  46,000                 .25                 11,500                     .1           11,500
Total         ...............  ..................  .....................  .....................          18,500
\1\There are no capital cost 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\
                                                      No. of         Annual Frequency per                               Hours Per
                21 CFR Section                     Recordkeepers        Recordkeeping       Total Annual Records       Recordkeeper        Total Hours
54.6                                                        1,000                      1                  1,000                    .25              250
Total                                           ..................  .....................  .....................  .....................             250
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: August 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-16915 Filed 8-24-05; 8:45 am]