[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, [email protected] 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:
[email protected].
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
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Estimated annualized burden hours
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Average time
Type of respondents Form Number of Number of per response Total hour
respondents responses (in hours) burden
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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).
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Total..................... ................ 25,571 119,457 .............. 14,649
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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