[Federal Register Volume 74, Number 244 (Tuesday, December 22, 2009)]
[Notices]
[Pages 68065-68066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-30390]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for 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, 
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 requires 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).

[[Page 68066]]



                                        Table--Estimates of Annual Burden
----------------------------------------------------------------------------------------------------------------
                                                   Number of     Frequency of   Average time per    Total hour
     Type of respondents             Form         respondents      response          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 are no capital costs, operating costs, or maintenance costs.
    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 [email protected]. 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: 
[email protected].
    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: December 15, 2009.
Kristine Miller,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E9-30390 Filed 12-21-09; 8:45 am]
BILLING CODE 4140-01-P