Submission of OMB Review; Comment Request; Drug Accountability Record (NCI), 61889-61890 [E7-21475]
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61889
Federal Register / Vol. 72, No. 211 / Thursday, November 1, 2007 / Notices
objectives of the study are to: (1) Assess
the NDPA award selection process; (2)
determine if the program was
implemented as planned; and (3)
determine if the process was conducted
in accordance with the overall mission
of the NDPA program. The findings will
provide valuable information
concerning: (1) The characteristics of
applicants and reviewers; (2) the criteria
used to evaluate and select awardees;
Responses per Respondent: 1. Average
Burden Hours Per Response: .25 (15
minutes), and Estimated Total Annual
Burden Hours Requested: 177.50 and
the annualized cost to respondents is
estimated at $9,662.50. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report. Table l and Table 2, respectively,
present data concerning the burden
hours and cost burdens for this data
collection.
and (3) aspects of the process that could
be revised or improved.
Frequency of Response: Once.
Affected Public: none. Type of
Respondents: Applicants, Reviewers
and Panelists, Liaisons. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report. Frequency of Response: Once.
Affected Public: none. Type of
Respondents: Applicants, Reviewers
and Panelists. Estimated Number of
Respondents: 710; Estimated Number of
TABLE 1.—ANNUALIZED ESTIMATE OF HOUR BURDEN
Number of
respondents
Type of respondents
Frequency of
response
Average time
for response
(hr)
Total hour
burden *
Applicants ......................................................................................................
Extramural evaluators ....................................................................................
600
110
1
1
.25
.25
150
2
Total ........................................................................................................
710
1
.25
177.50
* Total Burden = N Respondents*Response Frequency*minutes to complete/60.
TABLE 2.—ANNUALIZED COST TO RESPONDENTS
Number of
respondents
Type of respondents
Applicants ......................................................................................................
Extramural evaluators ....................................................................................
Total ........................................................................................................
Response
frequency
1200
220
710
Approx. hourly
wage rate
1
1
1
$55.00
55.00
55.00
Total
respondent
cost **
$8,250
1,512.50
9,662.50
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** Total Respondent Cost = N Respondents*Response Frequency*minutes to complete/60* hourly rate.
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 to be
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 G. Stephane
Philogene, PhD, Assistant Director for
Policy and Planning, Office of
Behavioral and Social Sciences
Research, National Institutes of Health,
31 Center Drive, Building 31, Room B2–
VerDate Aug<31>2005
19:40 Oct 31, 2007
Jkt 214001
B37, Bethesda, MD 20892, or call nontoll-free number 301–402–3902, or Email your request, including your
address to: philoges@od.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: October 24, 2007.
G. Stephane Philogene,
Assistant Director for Policy and Planning,
Office of Behavioral and Social Sciences
Research, National Institutes of Health.
[FR Doc. E7–21474 Filed 10–31–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission of OMB Review; Comment
Request; Drug Accountability Record
(NCI)
Summary: In compliance with the
requirement of Section 3507(a)(1)(D) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
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National Cancer Institute, the National
Cancer Institute (NIH) has submitted to
the Office of Management and Budget
(OMB) a request for review and
approval of the information collected
below. This proposed information
collection was previously published in
the Federal Register on August 13,
2007, Vol. 72, No. 55, Page 45251 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 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 December 1, 2007, unless it
displays a valid OMB control number.
Proposed Collection: Title: Drug
Accountability Record (NCI) (Form NIH
2564). Type of Information Collection
Request: Extension, with no changes
OMB No. 0925–0240. Expiration Date:
11/30/07. Need and Use of Information
Collection: Food and Drug
Administration (FDA) regulations
require investigators to establish a
record of the receipt, use and
disposition of all investigational agents.
The National Cancer Institute, (NCI), as
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01NON1
61890
Federal Register / Vol. 72, No. 211 / Thursday, November 1, 2007 / Notices
mstockstill on PROD1PC66 with NOTICES
a sponsor of investigational drug trials,
has the responsibility to assure the FDA
that investigators in its clinical trials
program are maintaining systems for
drug accountability. In order to fulfill
these requirements, a standard
Investigational Drug Accountability
Report Form (NIH 2564) was designed
to account for drug inventories and
usage by protocols. The data obtained
from the drug accountability record will
be used to keep track of the dispensing
of investigational anticancer agents to
patients. It is used by NCI management
to ensure that investigational drug
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 once every three years.
All comparisons are done with the
intention of ensuring protocol, patient
and drug compliance for patient and
drug compliance for patient safety and
protections.
Frequency of Response: Daily.
Affected Public: State or local
governments, businesses or other forprofit. Federal agencies or employees,
non-profit institutions, and small
business or organizations.
Type of Respondents: Investigators,
pharmacist, nurses, pharmacy
technicians, data manager. The annual
reporting burden is divided into two
major areas. These are the audits of Drug
Accountability Forms by Government
and its contractors and the use of the
forms by clinical research sites. The
burden is as follows:
Federal Burden: 1700 audits are
conducted of clinical research sites, a
minimum of three Drug Accountability
Forms are reviewed at the audit. Each
form requires 1⁄2 hour to review.
Number of Respondents: 1700.
Number of Responses per
Respondent: 3.
Average Burden per Response: 0.5
hours.
Annual Burden Hours: 2,250 hours.
Clinical Trial Site Burden: The annual
respondents’ burden for record keeping
is estimated to require 6,240 hours. The
record keeping burden represents an
average time required for multiple
entries (6 minutes or 0.1 hour per entry)
on the drug accountability form, the
average number of forms maintained by
each record keeper and the number of
record keepers.
Drug Accountability Forms
Number of Record Keepers: 3990.
Number of Responses per
Respondent: 16.
Average Burden per Response: 0.1 (6
minutes).
VerDate Aug<31>2005
19:40 Oct 31, 2007
Jkt 214001
Annual Burden Hours: 6,240 hours.
There are no Capital Costs, Operating
Costs, and Maintenance Cost to report.
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 to be 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.
Direct Comments to OMB: Written
comments or suggestions regarding the
item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
times, should be directed to the Office
of Management and Budget, Office of
Regulatory Affairs, New Executive
Office Building, Room 10235,
Washington, DC 20503, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Charles
L. Hall, Jr., Chief, Pharmaceutical
Management Branch, Cancer Therapy
Evaluation Program, Division of the
Cancer Treatment and Diagnosis, and
Centers, National Cancer Institute,
Executive Plaza North, Room 7148, 9000
Rockville Pike, Bethesda, MD 20892 or
call non-toll-free number 301–496–5725
or e-mail your request, including 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 30 days following the
date of this publication.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E7–21475 Filed 10–31–07; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Federal Emergency
Management Agency, DHS.
ACTION: Notice; 60-day notice and
request for comments; revision of a
currently approved collection, OMB
Number 1660–0011, FEMA Form 22–13.
AGENCY:
SUMMARY: The Federal Emergency
Management Agency (FEMA), as part of
its continuing effort to reduce
paperwork and respondent burden,
invites the general public and other
Federal agencies to take this
opportunity to comment on a proposed
revised information collection. In
accordance with the Paperwork
Reduction Act of 1995, this notice seeks
comments concerning an information
collection system for disaster program
accounts and debts receivable. The
automated portion of the system is an
accounts receivable system and is
complimented by a manual technique
that collects personal financial data
directly from individual debtors by their
completion of FEMA Form 22–13.
SUPPLEMENTARY INFORMATION: When
errors in payments occur or reviews and
audits determine that overpayments
were made in various disaster
entitlements, FEMA’s Disaster Finance
Branch (DFB), Office of the Chief
Financial Officer (CFO) records
pertinent receivable data, including
individuals’ personal data, within an
automated, commercial, off-the-shelf
(COTS) accounts receivable system—
ACCPAC. Using various screens, a
receivable is established to bill, monitor
payments and produce reports. If, for
lack of payment, an account receivable
becomes a debt, ACCPAC continues as
the receivable billing and collection
system, but additional personal
financial information is gathered and
used to determine an ability to pay in
setting requirements of installment
payment agreements. DHS debt
collection regulations, 6 CFR part 11,
require FEMA to maintain current credit
data on FEMA’s debtors. To determine
debtors’ financial condition, this
includes the individual debtors’ own
financial statements, executed under
penalty for false claim, concerning their
assets and liabilities and their income
and expenses. FEMA Form 22–13 is the
vehicle used to collect such data
directly from the individual debtor.
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]]>Agencies
[Federal Register Volume 72, Number 211 (Thursday, November 1, 2007)]
[Notices]
[Pages 61889-61890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21475]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission of OMB Review; Comment Request; Drug Accountability
Record (NCI)
Summary: In compliance with the requirement of Section
3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity
for public comment on proposed data collection projects, the National
Cancer Institute, the National Cancer Institute (NIH) has submitted to
the Office of Management and Budget (OMB) a request for review and
approval of the information collected below. This proposed information
collection was previously published in the Federal Register on August
13, 2007, Vol. 72, No. 55, Page 45251 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
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 December 1, 2007, unless
it displays a valid OMB control number.
Proposed Collection: Title: Drug Accountability Record (NCI) (Form
NIH 2564). Type of Information Collection Request: Extension, with no
changes OMB No. 0925-0240. Expiration Date: 11/30/07. Need and Use of
Information Collection: Food and Drug Administration (FDA) regulations
require investigators to establish a record of the receipt, use and
disposition of all investigational agents. The National Cancer
Institute, (NCI), as
[[Page 61890]]
a sponsor of investigational drug trials, has the responsibility to
assure the FDA that investigators in its clinical trials program are
maintaining systems for drug accountability. In order to fulfill these
requirements, a standard Investigational Drug Accountability Report
Form (NIH 2564) was designed to account for drug inventories and usage
by protocols. The data obtained from the drug accountability record
will be used to keep track of the dispensing of investigational
anticancer agents to patients. It is used by NCI management to ensure
that investigational drug 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 once every three years. All comparisons are done with
the intention of ensuring protocol, patient and drug compliance for
patient and drug compliance for patient safety and protections.
Frequency of Response: Daily.
Affected Public: State or local governments, businesses or other
for-profit. Federal agencies or employees, non-profit institutions, and
small business or organizations.
Type of Respondents: Investigators, pharmacist, nurses, pharmacy
technicians, data manager. The annual reporting burden is divided into
two major areas. These are the audits of Drug Accountability Forms by
Government and its contractors and the use of the forms by clinical
research sites. The burden is as follows:
Federal Burden: 1700 audits are conducted of clinical research
sites, a minimum of three Drug Accountability Forms are reviewed at the
audit. Each form requires \1/2\ hour to review.
Number of Respondents: 1700.
Number of Responses per Respondent: 3.
Average Burden per Response: 0.5 hours.
Annual Burden Hours: 2,250 hours.
Clinical Trial Site Burden: The annual respondents' burden for
record keeping is estimated to require 6,240 hours. The record keeping
burden represents an average time required for multiple entries (6
minutes or 0.1 hour per entry) on the drug accountability form, the
average number of forms maintained by each record keeper and the number
of record keepers.
Drug Accountability Forms
Number of Record Keepers: 3990.
Number of Responses per Respondent: 16.
Average Burden per Response: 0.1 (6 minutes).
Annual Burden Hours: 6,240 hours.
There are no Capital Costs, Operating Costs, and Maintenance Cost
to report.
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 to be 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.
Direct Comments to OMB: Written comments or suggestions regarding
the item(s) contained in this notice, especially regarding the
estimated public burden and associated response times, should be
directed to the Office of Management and Budget, Office of Regulatory
Affairs, New Executive Office Building, Room 10235, Washington, DC
20503, Attention: Desk Officer for NIH. To request more information on
the proposed project or to obtain a copy of the data collection plans
and instruments, contact Charles L. Hall, Jr., Chief, Pharmaceutical
Management Branch, Cancer Therapy Evaluation Program, Division of the
Cancer Treatment and Diagnosis, and Centers, National Cancer Institute,
Executive Plaza North, Room 7148, 9000 Rockville Pike, Bethesda, MD
20892 or call non-toll-free number 301-496-5725 or e-mail your request,
including 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 30 days
following the date of this publication.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E7-21475 Filed 10-31-07; 8:45 am]
BILLING CODE 4140-01-P
