[Federal Register Volume 81, Number 26 (Tuesday, February 9, 2016)]
[Notices]
[Pages 6876-6877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02447]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; Drug 
Accountability Report Form and Investigator Registration Procedure in 
the Conduct of Investigational Trials for the Treatment of Cancer (NCI)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Cancer Institute, the National 
Institutes of Health, has submitted to the Office of Management and 
Budget (OMB) a request for review and approval of the information 
collection listed below. This proposed information collection was 
previously published in the Federal Register on November 17, 2015 page 
71815 and allowed 60 days for public comment. No public comments were 
received. The purpose of this notice is to allow an additional 30 days 
for public comment. The National Cancer Institute, 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 currently valid OMB control number.
    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: Office of Management and Budget, Office of Regulatory 
Affairs, <a href="/cdn-cgi/l/email-protection#86c9cfd4c7d9f5f3e4ebeff5f5efe9e8c6e9ebe4a8e3e9f6a8e1e9f0"><span class="__cf_email__" data-cfemail="d59a9c87948aa6a0b7b8bca6a6bcbabb95bab8b7fbb0baa5fbb2baa3">[email protected]</span></a> or by fax to 202-395-6974, 
Attention: NIH Desk Officer.

[[Page 6877]]

    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
of the date of this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, or request more information on the 
proposed project, contact: Charles Hall, RPh, M.S., Chief, 
Pharmaceutical Management Branch, Cancer Therapy Evaluation Program, 
National Cancer Institute, 9609 Medical Center Drive, RM 5W240, MSC 
9725, Bethesda, Maryland 20892. Or call non-toll-free number (240) 276-
6575, or email your request, include your address to: 
<a href="/cdn-cgi/l/email-protection#fb939a97979893bb969a9297d5959293d59c948d"><span class="__cf_email__" data-cfemail="573f363b3b343f173a363e3b79393e3f79303821">[email protected]</span></a>.
    Formal requests for additional plans and instruments must be 
requested in writing.
    Proposed Collection: Drug Accountability Report Form and 
Investigator Registration Procedure in the Conduct of Investigational 
Trials for the Treatment of Cancer, 0925-0613, Expiration Date 03/31/
2016, Revision, National Cancer Institute (NCI), National Institutes of 
Health (NIH).
    Need and Use of Information Collection: The U.S. Food and Drug 
Administration (FDA) holds the National Cancer Institute (NCI) 
responsible, as a sponsor of investigational drug trials, for the 
collection of information about the clinical investigators who 
participate in these trials and to assure the FDA that systems for 
accountability are being maintained by investigators in its clinical 
trials program. The information collected is used to identify qualified 
investigators and to facilitate the submission and distribution of 
important information relative to the investigational drug and the 
response of the patient to that drug. Investigators are physicians who 
specialize in the treatment of patients with cancer. Data obtained from 
the Drug Accountability Record is used to track the dispensing of 
investigational anticancer agents from receipt from the NCI to 
dispensing or administration to patients. NCI and/or its auditors use 
this information for compliance purposes. The frequency of Response is 
up to 16 times per year. The affected public is private sector 
including businesses, other for-profit organizations, and non-profit 
institutions. The type of respondents are investigators, pharmacists, 
nurses, pharmacy technicians, and data managers.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 14,649 hours.

                                       Table 1--Estimates of Annual Burden
----------------------------------------------------------------------------------------------------------------
                                        Estimated annualized burden hours
-----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
     Type of  respondents             Form           Number of       Number of     per response     Total hour
                                                    respondents      responses      (in hours)        burden
----------------------------------------------------------------------------------------------------------------
Investigators and Designee for  Statement of              22,283               1           15/60           5,571
 Investigator Registration and   Investigator.
 DARF.
                                NCI/DCTD/CTEP             22,283               1           10/60           3,714
                                 Supplemental
                                 Investigator.
                                Financial                 22,283               1            5/60           1,857
                                 Disclosure
                                 Forms.
                                NCI/DCTD/CTEP              3,288              16            4/60           3,507
                                 Drug
                                 Accountability
                                 Record Form
                                 (DARF and DARF-
                                 Oral).
                               ---------------------------------------------------------------------------------
    Total.....................  ................          25,571         119,457  ..............          14,649
----------------------------------------------------------------------------------------------------------------


    Dated: February 3, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2016-02447 Filed 2-8-16; 8:45 am]
 BILLING CODE 4140-01-P


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