Proposed Collection; Comment Request; Investigator Registration and Financial Disclosure for Investigational Trials in Cancer Treatment (NCI), 27552-27553 [E9-13627]
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Federal Register / Vol. 74, No. 110 / Wednesday, June 10, 2009 / Notices
FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 513–
533–6800 (this is not a toll-free
number). Information requests can also
be submitted by e-mail to
OCAS@CDC.GOV.
teleconference dial-in. If you have
special needs for the meeting, please
contact (202) 690–7151.
Judith Sparrow,
Office of Programs and Coordination, Office
of the National Coordinator for Health
Information Technology.
[FR Doc. E9–13630 Filed 6–9–09; 8:45 am]
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Christine M. Branche,
Acting Director, National Institute for
Occupational Safety and Health.
[FR Doc. E9–13662 Filed 6–9–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–19–P
Proposed Collection; Comment
Request; Investigator Registration and
Financial Disclosure for Investigational
Trials in Cancer Treatment (NCI)
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the National Coordinator for
Health Information Technology; HIT
Standards Committee Meeting
ACTION:
Announcement of meeting.
SUMMARY: This notice announces the
second meeting of the HIT Standards
Committee in accordance with the
Federal Advisory Committee Act (Pub.
L. No. 92–463, 5 U.S.C., App.).
DATES: June 23, 2009, from 9 a.m. to 12
p.m. [Eastern]
ADDRESSES: The Omni Shoreham Hotel,
2500 Calvert Street, NW., Washington,
DC 20008, Diplomat Ballroom.
FOR FURTHER INFORMATION CONTACT:
https://healthit.hhs.gov.
SUPPLEMENTARY INFORMATION:
The meeting will include
presentations from the HIT Standards
Committee Workgroups. The meeting is
a Web-based meeting with
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:
Investigator Registration and Financial
Disclosure for Investigational Trials in
Cancer Treatment (NCI). Type of
Information Collection Request: Existing
Collection in use without an OMB
Control Number. Need and Use of
Information Collection: Food and Drug
Administration (FDA) regulations
require sponsors to obtain information
from the investigator before permitting
the investigator to begin participation in
investigational studies. The National
Cancer Institute (NCI), as a sponsor of
investigational drug trials, has the
responsibility to assure the FDA that
investigators in its clinical trials
program are qualified by training and
experience as appropriate experts to
investigate the drug. In order to fulfill
these requirements, a standard
Statement of Investigator (FDA Form
1572 modified), Supplemental
Investigator Data Form, Financial
Disclosure Form and Curriculum vitae
(CV) are required. The data obtained
from these forms allows the NCI to
evaluate the qualifications of the
investigator, identify appropriate
personnel to receive shipment of
investigational agent, ensure supplies
are not diverted for inappropriate
protocol or patient use and identify
financial conflicts of interest.
Comparisons are done with the
intention of ensuring protocol, patient
safety and drug compliance for patient
and drug compliance for patient safety
and protections.
Frequency of Response: Annually.
Affected Public: Public sector,
businesses other for-profit. Federal
agencies or employees, non-profit
institutions and a very small number of
private practice physicians.
Type of Respondents: Health care
investigators. The annual reporting
burden is limited to those physicians
who choose to participate in NCI
sponsored investigational trials to
identify new medicinal agents to treat
and relieve those patients suffering from
cancer. It is estimated that the total
annual burden will be 8,564 hours, and
include 17,128 investigators, for this
project (see Table 1).
TABLE 1—ESTIMATES OF ANNUAL BURDEN
Number of respondents
Type of respondents
Form
Investigators and Designee ...
Statement of Investigator .....
Supplemental Investigator ....
Financial Disclosure .............
...............................................
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Totals ..............................
There is no capital, operating or
maintenance costs 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
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17,128
17,128
17,128
17,128
Frequency of
response
Average time per response
1
1
1
........................
0.25 (15 minutes) .................
0.167 (10 minutes) ...............
0.083 (5 minutes) .................
...............................................
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.
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Frm 00048
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Total hour burden
4,282
2,855
1,427
8,564
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 E-
E:\FR\FM\10JNN1.SGM
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Federal Register / Vol. 74, No. 110 / Wednesday, June 10, 2009 / Notices
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 60 days following the
date of this publication.
Dated: June 3, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E9–13627 Filed 6–9–09; 8:45 am]
Dated: June 3, 2009.
Lorenzo Falgiano,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E9–13557 Filed 6–9–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
BILLING CODE 4140–01–P
Advisory Council for the Elimination of
Tuberculosis Meeting (ACET)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Respirable
Dust Control Related to Mining,
Program Announcement Number (PA)
07–318, Initial Review
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
erowe on PROD1PC63 with NOTICES
Time and Date: 9 a.m.–5 p.m., July 14,
2009 (Closed).
Place: Marriott Waterfront, 700 Aliceanna
Street, Baltimore, Maryland 21202;
Telephone: (410) 385–3000.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters to be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Respirable Dust Control Related
to Mining, PA 07–318.’’
Contact Person for More Information:
George Bockosh, Scientific Review
Administrator, Office Of Extramural
Programs, National Institute for Occupational
Safety and Health, CDC, 1600 Clifton Road,
NE., Mailstop P05, Atlanta Georgia 30333;
Telephone: (412) 352–5181;
GBockosh@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned committee:
Times and Dates:
8:30 a.m.–4:30 p.m., July 14, 2009.
8:30 a.m.–2:30 p.m., July 15, 2009.
Place: Corporate Square, Building 8, 1st
Floor Conference Room, Atlanta, Georgia
30333, Telephone (404) 639–8317.
Status: Open to the public, limited only by
the space available. The meeting room
accommodates approximately 100 people.
Purpose: This council advises and makes
recommendations to the Secretary of Health
and Human Services, the Assistant Secretary
for Health, and the Director, CDC, regarding
the elimination of tuberculosis. Specifically,
the Council makes recommendations
regarding policies, strategies, objectives, and
priorities; addresses the development and
application of new technologies; and reviews
the extent to which progress has been made
toward eliminating tuberculosis.
Matters To Be Discussed: Agenda items
include issues pertaining to tuberculosis in
special populations; Federal agencies and
their role in global tuberculosis control and
research; and research updates and other
related tuberculosis issues. Agenda items are
subject to change as priorities dictate.
Contact Person for More Information:
Margie Scott-Cseh, Coordinating Center for
Infectious Diseases, Strategic Business Unit,
1600 Clifton Road, NE., Mailstop E–07,
Atlanta, Georgia 30333, Telephone (404)
639–8317.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register Notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: June 3, 2009.
Lorenzo Falgiano,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E9–13558 Filed 6–9–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Member
Conflict Review, Program
Announcement Number (PA) 07–318,
Initial Review
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date: 1 p.m.–3 p.m., July 22,
2009 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Member Conflict Review, PA
07–318.’’
Contact Person for More Information: Chris
Langub, Scientific Review Administrator,
Office Of Extramural Programs, National
Institute for Occupational Safety and Health,
CDC, 1600 Clifton Road, NE., Mailstop E74,
Atlanta, Georgia 30333; Telephone: (404)
498–2543.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: June 3, 2009.
Lorenzo Falgiano,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E9–13559 Filed 6–9–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Center for Injury Prevention
and Control Initial Review Group,
(NCIPC IRG)
Times and Dates: 12:30 p.m.–7 p.m.
(Closed)
Correction: This notice was published
in the Federal Register on May 19,
2009, Volume 74, Number 95, Page
23423. The timeframe for the closed
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]]>Agencies
[Federal Register Volume 74, Number 110 (Wednesday, June 10, 2009)]
[Notices]
[Pages 27552-27553]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13627]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Investigator Registration
and Financial Disclosure for Investigational Trials in Cancer Treatment
(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,
the National Cancer Institute (NIH) will publish periodic summaries to
the Office of Management and Budget (OMB) for review and approval.
Proposed Collection: Title: Investigator Registration and Financial
Disclosure for Investigational Trials in Cancer Treatment (NCI). Type
of Information Collection Request: Existing Collection in use without
an OMB Control Number. Need and Use of Information Collection: Food and
Drug Administration (FDA) regulations require sponsors to obtain
information from the investigator before permitting the investigator to
begin participation in investigational studies. The National Cancer
Institute (NCI), as a sponsor of investigational drug trials, has the
responsibility to assure the FDA that investigators in its clinical
trials program are qualified by training and experience as appropriate
experts to investigate the drug. In order to fulfill these
requirements, a standard Statement of Investigator (FDA Form 1572
modified), Supplemental Investigator Data Form, Financial Disclosure
Form and Curriculum vitae (CV) are required. The data obtained from
these forms allows the NCI to evaluate the qualifications of the
investigator, identify appropriate personnel to receive shipment of
investigational agent, ensure supplies are not diverted for
inappropriate protocol or patient use and identify financial conflicts
of interest. Comparisons are done with the intention of ensuring
protocol, patient safety and drug compliance for patient and drug
compliance for patient safety and protections.
Frequency of Response: Annually.
Affected Public: Public sector, businesses other for-profit.
Federal agencies or employees, non-profit institutions and a very small
number of private practice physicians.
Type of Respondents: Health care investigators. The annual
reporting burden is limited to those physicians who choose to
participate in NCI sponsored investigational trials to identify new
medicinal agents to treat and relieve those patients suffering from
cancer. It is estimated that the total annual burden will be 8,564
hours, and include 17,128 investigators, for this project (see Table
1).
Table 1--Estimates of Annual Burden
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time Total hour
Type of respondents Form respondents response per response burden
----------------------------------------------------------------------------------------------------------------
Investigators and Designee... Statement of 17,128 1 0.25 (15 4,282
Investigator. minutes).
Supplemental 17,128 1 0.167 (10 2,855
Investigator. minutes).
Financial 17,128 1 0.083 (5 1,427
Disclosure. minutes).
Totals................... ................ 17,128 .............. ............... 8,564
----------------------------------------------------------------------------------------------------------------
There is no capital, operating or maintenance costs 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-
[[Page 27553]]
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 60 days
following the date of this publication.
Dated: June 3, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E9-13627 Filed 6-9-09; 8:45 am]
BILLING CODE 4140-01-P
