[Federal Register Volume 80, Number 221 (Tuesday, November 17, 2015)]
[Notices]
[Pages 71815-71816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
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Average time
Type of respondents Form Number of Frequency of per response Total hour
respondents response (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. (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).
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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