Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices 40199 

[FR Doc. E9–19199 Filed 8–10–09; 8:45 am] 

BILLING CODE 4150–37–C 

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

Type of 

respondents Form Number of respondents 

Frequency of 

response 

Average time 

per response 

Total hour 

burden 

Investigators and Designee ... Statement of Investigator ..... 17,128 1 0.25 .......................................

(15 minutes) ..........................

4,282 

Supplemental Investigator .... 17,128 1 0.167 .....................................

(10 minutes) ..........................

2,855 

Financial Disclosure ............. 17,128 1 0.083 .....................................

(5 minutes) ............................

1,427 

Totals .............................. ............................................... 17,128 ........................ ............................................... 8,564 

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 


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