Submission of OMB Review; Comment Request; Investigator Registration and Financial Disclosure for Investigational Trials in Cancer Treatment (NCI), 40199 [E9-19207]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 74, Number 153 (Tuesday, August 11, 2009)]
[Notices]
[Page 40199]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19207]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission of OMB Review; Comment Request; Investigator 
Registration and Financial Disclosure for Investigational Trials in 
Cancer Treatment (NCI)

SUMMARY: In compliance with the requirement of section 3507(a)(1)(D) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the National Cancer Institute, 
(NIH) has submitted to the Office of Management and Budget (OMB) a 
request for review and approval of the information collected below. 
This proposed information collection was previously published in the 
Federal Register on June 10, 2009 (74 FR 27552), and allowed 60 days 
for public comment. One public comment was received regarding 
pharmaceutical testing. The submitter responded to the e-mail. The 
purpose of this notice is to allow an additional 30 days for public 
comment. The National Institutes of Health may not conduct or sponsor, 
and the respondent is not required to respond to, an information 
collection that has been extended, revised, or implemented on or after 
October 1, 1995, unless it displays a valid OMB control number.
    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 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 NCI will accept the 
investigator's CV in any format. All investigators maintain a CV as 
part of their academic and professional practice. 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 or other for-profit that 
will include Federal agencies or employees, non-profit institutions and 
a very small number of private practice physicians. Type of 
Respondents: 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.
    The annualized respondents' burden for record keeping is estimated 
to require 8,564 hours (see table below).

                                        Table--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
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Investigators and Designee...  Statement of              17,128               1  0.25...........           4,282
                                Investigator.                                    (15 minutes)...
                               Supplemental              17,128               1  0.167..........           2,855
                                Investigator.                                    (10 minutes)...
                               Financial                 17,128               1  0.083..........           1,427
                                Disclosure.                                      (5 minutes)....
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    Totals...................  ................          17,128  ..............  ...............           8,564
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    There are no capital costs, operating costs, and maintenance cost.
    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.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the Attention: NIH Desk Officer, Office of Management and 
Budget, at OIRA_submission@omb.eop.gov or by fax to 202-395-6974. 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-mail your request, including your address, to: 
Hallch@mail.nih.gov.
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
following the date of this publication.

    Dated: August 5, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E9-19207 Filed 8-10-09; 8:45 am]
BILLING CODE 4140-01-P