Submission of OMB Review; Comment Request; Drug Accountability Record, 45251-45252 [E7-15750]
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Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Notices
Regulations (ICCR) Meeting in Brussels,
Belgium’’ to provide information on the
process and receive comments on issues
that may be relevant to discussions
being held at the ICCR meeting in
Brussels, Belgium. The purpose of the
meeting is to solicit public input prior
to the first meeting of this group in
Brussels on September 27, 2007.
Date and Time: The meeting will be
held on Tuesday, August 28, 2007, from
2 p.m. to 3:30 p.m.
Location: The meeting will be held at
5600 Fishers Lane, 3rd fl., Chesapeake
Conference Room, Rockville, MD 20857.
For security reasons, all attendees must
preregister and are asked to arrive no
later than 1:50 p.m., as you will be
escorted from the front entrance of 5600
Fishers Lane to the Chesapeake
Conference Room.
Contact Person: All participants must
register with Michelle Limoli, Office of
the Commissioner, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, by e-mail:
michelle.limoli@fda.hhs.gov or FAX:
301–827–0003.
Registration and Requests for Oral
Presentations: Send registration
information (including name, title, firm
name, address, telephone, and fax
number), and written material and
requests to make oral presentations, to
the contact person by August 21, 2007.
If you need special accommodations
due to a disability, please contact
Michelle Limoli at least 7 days in
advance.
Transcripts: Transcripts of the
meeting may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 15 working days after the
meeting at a cost of 10 cents per page.
SUPPLEMENTARY INFORMATION: The ICCR
is a voluntary international group of
cosmetics regulatory authorities from
the United States, Japan, the European
Union, and Canada. It should be noted
that the definition and regulatory
classification of ‘‘cosmetics’’ in the
different countries/regions is not
identical. For this reason, the ICCR will
consider some U.S. over-the-counter
drugs that are regulated as ‘‘cosmetics’’
outside the United States. ICCR
members are: the Food and Drug
Administration of the United States of
America; the Ministry of Health, Labour,
and Welfare of Japan; the European
Commission Directorate General
Enterprise; and Health Canada. This
multilateral framework was created to
identify ways to remove regulatory
obstacles among the regions, while
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16:19 Aug 10, 2007
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maintaining the highest level of global
consumer protection. The first meeting
of the group will occur in Brussels,
Belgium, September 27, 2007.
The ICCR will operate on a consensus
basis whereby all decisions of the
representatives of the regulatory
members and subsequent actions must
be taken by consensus. Members agree
to take steps as appropriate to
implement the items that have reached
consensus within the boundaries of
their legal and institutional constraints.
In this respect, they agree to promote
the documents reflecting the consensus
within their own jurisdictions and to
seek convergence of regulatory policies
and practices.
The members’ responsibilities will
include providing overall strategic
guidance and direction to activities of
ICCR; defining subject areas for ICCR
activities and deciding on future topics
for activity; exchanging information on
regulatory, trade, and market
developments of interest; determining
policies related to the ICCR process,
administration, and external
communications; appointing ad-hoc
working groups to carry out technical
work as needed; adopting guidelines
and policy statements, including those
developed by the ad-hoc working
groups; and taking on any other
initiatives that contribute to achieving
ICCR objectives.
It is recognized that successful
implementation requires the input of a
constructive dialogue with the
cosmetics’ industry trade associations
and other relevant stakeholders, hence
the scheduling of this public meeting.
The industry trade associations of
each region will gather input in order to
represent all affected industry sectors on
specific issues at ICCR meetings. Prior
to ICCR meetings, well in advance to
allow adequate time for preparation,
industry will suggest items for priority
actions to be consider by ICCR
members. During the ICCR meeting,
industry trade associations will enter in
a constructive dialogue with the
members and give their opinion and
directions for future work.
According to specific needs, ICCR
working groups may be established with
a precise mandate on an ad-hoc and
temporary basis by the members.
Working groups are created primarily
for the purpose of developing proposed
guidelines and policy statements for
adoption by the members. The working
group participants are appointed by
consensus of the members. Outside
technical experts may be invited on an
as-needed basis.
The ICCR will meet at least once per
year, but may alter the frequency of
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45251
meetings if considered necessary to
ensure progress. The venue of meetings
rotates among the territory of the four
members.
Interested persons may present data,
information, or views orally or in
writing, on issues pending at the public
meeting. Oral presentations from the
public will be scheduled between
approximately 3 p.m. and 3:30 p.m.
Time allotted for oral presentations may
be limited by the numbers requesting to
speak; however no more than 10
minutes will be allotted per speaker.
Those desiring to make oral
presentations should notify the contact
person by August 24, 2007, and submit
a brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses,
phone number, fax, and e-mail of
proposed participants, and an
indication of the approximate time
requested to make their presentation.
Dated: August 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–3954 Filed 8–9–07; 1:38 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission of OMB Review; Comment
Request; Drug Accountability Record
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, the National
Cancer Institute (NIH) will publish
periodic summaries to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection
Title: Drug Accountability Record
(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
a sponsor 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
E:\FR\FM\13AUN1.SGM
13AUN1
45252
Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Notices
jlentini on PROD1PC65 with NOTICES
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: 1,700 audits are
conducted of clinical research sites, a
minimum of three Drug Accountability
Forms are reviewed at the audit. Each
form requires a 1⁄2 hour to review.
Number of Respondents: 1,700.
Number of Responses per
Respondent: 3.
Average Burden per Response: 0.5
hours.
Annual Burden Hours: 2,250 hours.
Clinical Trial Site Burden: The
annualized respondents’ burden for
recordkeeping is estimated to require
6,240 hours. The recordkeeping burden
represents an average time required for
multiple entries (4 minutes or 0.1 hour
per entry) on the drug accountability
form, the average number of forms
maintained by each recordkeeper and
the number of recordkeepers.
Drug Accountability Forms
Number of Record Keepers: 3,990.
Number of Responses per
Respondent: 16.
Average Burden per Response: 0.1.
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
VerDate Aug<31>2005
16:19 Aug 10, 2007
Jkt 211001
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 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 nontoll-free number 301–496–5725 or email your request, including your
address to: Hallch@mail.nih.gov.
Due Date: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days following the date of this
publication.
Dated: August 3, 2007.
Ann E. Duane,
Acting NCI Project Clearance Liaison,
National Institutes of Health.
[FR Doc. E7–15750 Filed 8–10–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
PO 00000
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Fmt 4703
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inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
An Improved Chromosomal
Comparative Genomic Hybridization
(CGH) Microarray for the Detection of
Cancer Associated Genome
Amplification and Deletion Events
Description of Technology: The
progression and therapeutic response of
cancer is closely associated with
chromosomal instability (i.e. genomic
amplifications and deletions). The most
widely used technique to detect these
small changes in the genome is CGH.
CGH utilizes nucleic acid hybridization
to oligonucleotide features
corresponding to specific,
predetermined regions of the genome to
detect DNA copy number changes. Due
to the size of the human genome, it is
necessary to have high-density features
to detect small amplification and
deletion events within the genome.
The current invention is based on a
CGH microarray with oligonucleotide
features that provides a high-density
coverage. More specifically, the
inventors have used 60-mer
oligonucleotide features within a
previously shown set of 36 tumor
associated genes/genomic regions and
have successfully detected small
changes in DNA copy number with high
density coverage (1 feature per 400bp).
Furthermore, the inventors have used a
fade-out design for coverage of the
flanking regions and cover the
remainder of the genome at an average
density of 1 feature per 100kb.
Applications:
1. CGH microarray can be used to
detect small regions of genomic
instability within cancer associated
genes, while larger events can also be
detected with similar efficacy.
2. Gene amplification and deletion
profiles of patient samples can be used
in diagnosis and therapeutic decision
making.
Advantages:
1. Easy to use, CGH microarray
technique, based on current technology.
2. Technology detects small changes
in tumor associated genomic instability
E:\FR\FM\13AUN1.SGM
13AUN1
]]>Agencies
[Federal Register Volume 72, Number 155 (Monday, August 13, 2007)]
[Notices]
[Pages 45251-45252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15750]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission of OMB Review; Comment Request; Drug Accountability
Record
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, the National Cancer Institute (NIH) will publish
periodic summaries to the Office of Management and Budget (OMB) for
review and approval.
Proposed Collection
Title: Drug Accountability Record (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 a sponsor
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
[[Page 45252]]
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: 1,700 audits are conducted of clinical research
sites, a minimum of three Drug Accountability Forms are reviewed at the
audit. Each form requires a \1/2\ hour to review.
Number of Respondents: 1,700.
Number of Responses per Respondent: 3.
Average Burden per Response: 0.5 hours.
Annual Burden Hours: 2,250 hours.
Clinical Trial Site Burden: The annualized respondents' burden for
recordkeeping is estimated to require 6,240 hours. The recordkeeping
burden represents an average time required for multiple entries (4
minutes or 0.1 hour per entry) on the drug accountability form, the
average number of forms maintained by each recordkeeper and the number
of recordkeepers.
Drug Accountability Forms
Number of Record Keepers: 3,990.
Number of Responses per Respondent: 16.
Average Burden per Response: 0.1.
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.
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 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.
Due Date: Comments regarding this information collection are best
assured of having their full effect if received within 60 days
following the date of this publication.
Dated: August 3, 2007.
Ann E. Duane,
Acting NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E7-15750 Filed 8-10-07; 8:45 am]
BILLING CODE 4140-01-P
