Proposed Collection; Comment Request; the Drug Accountability Record (Form NIH 2564) (NCI), 46945 [2010-19158]
Download as PDF
<![CDATA[
46945
Federal Register / Vol. 75, No. 149 / Wednesday, August 4, 2010 / Notices
Number of
respondents
Instrument
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
Report ..................................................................................
600
1
600
1
600
Total ..............................................................................
600
1
600
14
8,400
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov
or by fax to 202–395–6974. Please direct
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
Dated: July 28, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–19121 Filed 8–3–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; the Drug Accountability
Record (Form NIH 2564) (NCI)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
SUMMARY:
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI), 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.
Proposed Collection
Title: The Drug Accountability Record
(Form NIH 2564) (OMB No. 0925–0240).
Type of Information Collection Request:
Extension with changes. Need and Use
of Information Collection: The Food and
Drug Administration (FDA) regulations
require investigators to establish a
record of receipt, use and disposition of
all investigational agents. The National
Cancer Institute (NCI), as a sponsor of
investigational agent trials, has the
responsibility to assure the FDA that
investigators in its clinical trials
program are maintaining systems for
agent accountability. In order to fulfill
these requirements, a standard
Investigational Drug Accountability
Report Form (DARF) NIH–2564, was
designed to account for agent
inventories and usage by protocols. The
data obtained from the agent
accountability record will be used to
keep track of the dispensing of
investigational agent anticancer agents
to patients. It is used by the NCI
management to ensure that
investigational agent supplies are not
diverted for inappropriate protocol or
patient use. The information is also
compared to patient flow sheets
(protocol reporting forms) during site
visits conducted for each investigator
every three years. All comparisons are
done with the intention of ensuring
protocol, patient and agent compliance
for patient safety and protection.
Frequency of Response: Approximately
16 times per year. Affected Public:
Private sector including businesses,
other for-profit organizations, and nonprofit institutions. Type of Respondents:
Investigators, pharmacists, nurses,
pharmacy technicians, and data
managers. The annualized respondents’
burden for record keeping is estimated
to require 6,714 hours (Table 1). There
are no capital costs, operating costs, or
maintenance costs to report.
TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS
Number of
respondents
Type of respondents
Investigators, or Designees .............................................................................
mstockstill on DSKH9S0YB1PROD with NOTICES
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 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
VerDate Mar<15>2010
16:26 Aug 03, 2010
Jkt 220001
4,196
collection techniques or other forms of
information technology.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Charles, Hall, RPh,
M.S., Chief, Pharmaceutical
Management Branch, Cancer Therapy
Evaluation Program, National Cancer
Institute, Executive Plaza North, Room
7149, 9000 Rockville Pike, Bethesda,
Maryland 20891. Or call non-toll-free
number 301–496–5725 or e-mail your
request, include 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 60-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Frequency of
response
16
Average time
per response
Annual burden
hours
6/60 (0.1)
6,714
Dated: July 28, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2010–19158 Filed 8–3–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Multi-Ethnic Study of
Atherosclerosis (MESA) Event
Surveillance
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
SUMMARY:
E:\FR\FM\04AUN1.SGM
04AUN1
]]>Agencies
[Federal Register Volume 75, Number 149 (Wednesday, August 4, 2010)]
[Notices]
[Page 46945]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19158]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; the Drug Accountability
Record (Form NIH 2564) (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 National Cancer Institute
(NCI), 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.
Proposed Collection
Title: The Drug Accountability Record (Form NIH 2564) (OMB No.
0925-0240). Type of Information Collection Request: Extension with
changes. Need and Use of Information Collection: The Food and Drug
Administration (FDA) regulations require investigators to establish a
record of receipt, use and disposition of all investigational agents.
The National Cancer Institute (NCI), as a sponsor of investigational
agent trials, has the responsibility to assure the FDA that
investigators in its clinical trials program are maintaining systems
for agent accountability. In order to fulfill these requirements, a
standard Investigational Drug Accountability Report Form (DARF) NIH-
2564, was designed to account for agent inventories and usage by
protocols. The data obtained from the agent accountability record will
be used to keep track of the dispensing of investigational agent
anticancer agents to patients. It is used by the NCI management to
ensure that investigational agent supplies are not diverted for
inappropriate protocol or patient use. The information is also compared
to patient flow sheets (protocol reporting forms) during site visits
conducted for each investigator every three years. All comparisons are
done with the intention of ensuring protocol, patient and agent
compliance for patient safety and protection. Frequency of Response:
Approximately 16 times per year. Affected Public: Private sector
including businesses, other for-profit organizations, and non-profit
institutions. Type of Respondents: Investigators, pharmacists, nurses,
pharmacy technicians, and data managers. The annualized respondents'
burden for record keeping is estimated to require 6,714 hours (Table
1). There are no capital costs, operating costs, or maintenance costs
to report.
Table 1--Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time Annual burden
Type of respondents respondents response per response hours
----------------------------------------------------------------------------------------------------------------
Investigators, or Designees..................... 4,196 16 6/60 (0.1) 6,714
----------------------------------------------------------------------------------------------------------------
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 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.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Charles, Hall, RPh, M.S., Chief, Pharmaceutical
Management Branch, Cancer Therapy Evaluation Program, National Cancer
Institute, Executive Plaza North, Room 7149, 9000 Rockville Pike,
Bethesda, Maryland 20891. Or call non-toll-free number 301-496-5725 or
e-mail your request, include 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 60-days
of the date of this publication.
Dated: July 28, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-19158 Filed 8-3-10; 8:45 am]
BILLING CODE 4140-01-P
