[Federal Register Volume 74, Number 110 (Wednesday, June 10, 2009)]
[Notices]
[Pages 27552-27553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-13627]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Investigator Registration 
and Financial Disclosure for Investigational Trials in Cancer Treatment 
(NCI)

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the National Cancer Institute, 
the National Cancer Institute (NIH) will publish periodic summaries to 
the Office of Management and Budget (OMB) for review and approval.
    Proposed Collection: Title: Investigator Registration and Financial 
Disclosure for Investigational Trials in Cancer Treatment (NCI). Type 
of Information Collection Request: Existing Collection in use without 
an OMB Control Number. Need and Use of Information Collection: Food and 
Drug Administration (FDA) regulations require sponsors to obtain 
information from the investigator before permitting the investigator to 
begin participation in investigational studies. The National Cancer 
Institute (NCI), as a sponsor of investigational drug trials, has the 
responsibility to assure the FDA that investigators in its clinical 
trials program are qualified by training and experience as appropriate 
experts to investigate the drug. In order to fulfill these 
requirements, a standard Statement of Investigator (FDA Form 1572 
modified), Supplemental Investigator Data Form, Financial Disclosure 
Form and Curriculum vitae (CV) are required. The data obtained from 
these forms allows the NCI to evaluate the qualifications of the 
investigator, identify appropriate personnel to receive shipment of 
investigational agent, ensure supplies are not diverted for 
inappropriate protocol or patient use and identify financial conflicts 
of interest. Comparisons are done with the intention of ensuring 
protocol, patient safety and drug compliance for patient and drug 
compliance for patient safety and protections.
    Frequency of Response: Annually.
    Affected Public: Public sector, businesses other for-profit. 
Federal agencies or employees, non-profit institutions and a very small 
number of private practice physicians.
    Type of Respondents: Health care investigators. The annual 
reporting burden is limited to those physicians who choose to 
participate in NCI sponsored investigational trials to identify new 
medicinal agents to treat and relieve those patients suffering from 
cancer. It is estimated that the total annual burden will be 8,564 
hours, and include 17,128 investigators, for this project (see Table 
1).

                                       Table 1--Estimates of Annual Burden
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                                                    Number of     Frequency of     Average time     Total hour
     Type of respondents             Form          respondents      response       per response       burden
----------------------------------------------------------------------------------------------------------------
Investigators and Designee...  Statement of              17,128               1  0.25 (15                  4,282
                                Investigator.                                     minutes).
                               Supplemental              17,128               1  0.167 (10                 2,855
                                Investigator.                                     minutes).
                               Financial                 17,128               1  0.083 (5                  1,427
                                Disclosure.                                       minutes).
    Totals...................  ................          17,128  ..............  ...............           8,564
----------------------------------------------------------------------------------------------------------------

    There is no capital, operating or maintenance costs to report.
    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies are invited on one or more of the 
following points: (1) Whether the proposed collection of information is 
necessary for the proper performance of the function of the agency, 
including whether the information will have practical utility; (2) The 
accuracy of the agency'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 those who are to 
respond, including the use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact Charles L. Hall, Jr., Chief, Pharmaceutical 
Management Branch, Cancer Therapy Evaluation Program, Division of the 
Cancer Treatment and Diagnosis, and Centers, National Cancer Institute, 
Executive Plaza North, Room 7148, 9000 Rockville Pike, Bethesda, MD 
20892 or call non-toll-free number 301-496-5725 or E-

[[Page 27553]]

mail your request, including your address to: [email protected].
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
following the date of this publication.

    Dated: June 3, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E9-13627 Filed 6-9-09; 8:45 am]
BILLING CODE 4140-01-P