80 FR 71815 - Proposed Collection; 60-Day Comment Request; Drug Accountability Report Form and Investigator Registration Procedure in the Conduct of Investigational Trials for the Treatment of Cancer (NCI)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 221 (November 17, 2015)

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 Cancer Therapy Evaluation Program (CTEP)/Division of Cancer Therapy and Diagnostics (DCTD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, 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: [email protected] Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Title: 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: Revision. 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 capital costs, operating costs or maintenance costs. The total estimated annualized burden hours are 22,645 hours.

[Federal Register Volume 80, Number 221 (Tuesday, November 17, 2015)]
[Notices]
[Pages 71815-71816]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-29246]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; Drug Accountability 
Report Form and Investigator Registration Procedure in the Conduct of 
Investigational Trials for the Treatment of Cancer (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 Cancer Therapy Evaluation 
Program (CTEP)/Division of Cancer Therapy and Diagnostics (DCTD), the 
National Institutes of Health (NIH) will publish periodic summaries of 
proposed projects to be submitted to the Office of Management and 
Budget (OMB) for review and approval.
    Written comments and/or suggestions from the public and affected 
agencies are invited to address 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) The quality, utility, and clarity of the information to be 
collected; and (4) 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.
    To Submit Comments and for Further Information: To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
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: [email protected].
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.
    Proposed Collection: Title: 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: Revision. 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 capital costs, 
operating costs or maintenance costs. The total estimated annualized 
burden hours are 22,645 hours.

Estimated Annualized Burden Hours

[[Page 71816]]



                                       Table 1--Estimates of Annual Burden
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
      Type of respondents             Form           Number of     Frequency of    per response     Total hour
                                                    respondents      response       (in hours)        burden
----------------------------------------------------------------------------------------------------------------
Investigators and Designee for  Statement of              22,283               1           15/60           5,571
 Investigator Registration and   Investigator
 DARF.                           (Attachments
                                 3A, 3B or 10).
                                NCI/DCTD/CTEP             22,283               1           10/60           3,721
                                 Supplemental
                                 Investigator
                                 (Attachment 4).
                                Financial                 22,283               1            5/60           1,849
                                 Disclosure
                                 Forms
                                 (Attachment 5A
                                 or 5B).
                                NCI/DCTD/CTEP              3,288              16            4/60           3,525
                                 Drug
                                 Accountability
                                 Record Form
                                 (DARF and DARF-
                                 Oral)
                                 (Attachments 1
                                 & 2).
----------------------------------------------------------------------------------------------------------------


    Dated: November 9, 2015.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2015-29246 Filed 11-16-15; 8:45 am]
 BILLING CODE 4140-01-P