Proposed Collection; Comment Request; Clinical Trials Reporting Program (CTRP) Database (NCI), 57684-57685 [E9-26875]
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57684
Federal Register / Vol. 74, No. 215 / Monday, November 9, 2009 / Notices
Dated: November 2, 2009.
Marilyn S. Radke,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–26935 Filed 11–6–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
Proposed Information Collection
Activity; Comment Request
Administration for Children and
Families
Proposed Projects
Title: Tax Refund Offset Program and
Administrative Offset Program (TROP/
ADOP).
OMB No.: 0970–0161.
Description: The Tax Refund Offset
and Administration Offset Programs
collect past-due child support by
intercepting certain Federal payments,
including Federal tax refunds, of
parents who have been ordered to pay
child support and who are behind in
paying the debt. The program is a
cooperative effort among the
Department of the Treasury’s Financial
Management Service (FMS), the Federal
Office of Child Support Enforcement
(OCSE), and State Child Support
Enforcement (CSE) agencies. The
Passport Denial program reports noncustodial parents who owe arrears above
a threshold to the Department of State
(DOS), which will then deny passports
to these individuals. On an ongoing
basis, CSE agencies submit to OCSE the
names, Social Security numbers (SSNs),
and the amount(s) of past-due child
support of people who are delinquent in
making child support payments.
Respondents: State IV–D Agencies
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
mstockstill on DSKH9S0YB1PROD with NOTICES
Input Record ....................................................................................................
Output Record .................................................................................................
Payment File ....................................................................................................
Certification Letter ............................................................................................
Estimated Total Annual Burden
Hours: 2,534.76
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
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Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: November 3, 2009.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E9–26852 Filed 11–6–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Clinical Trials Reporting
Program (CTRP) Database (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: Clinical
Trials Reporting Program (CTRP)
Database. Type of Information
Collection Request: Revision of
currently approved collection [OMB No.
0925–0600, expiration date 01/31/2010].
Need and Use of Information Collection:
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
52
52
52
1
Average
burden hours
per response
0.30
0.46
0.14
0.40
Total burden
hours
842.40
1,291.68
379.08
21.60
The NCI is developing an electronic
resource, the NCI Clinical Trials
Reporting Program (CTRP) Database, to
serve as a single, definitive source of
information about all NCI-supported
clinical research, thereby enabling the
NCI to execute its mission to reduce the
burden of cancer and to ensure an
optimal return on the nation’s
investment in cancer clinical research.
Information will be submitted by
clinical research administrators as
designees of clinical investigators who
conduct NCI-supported clinical
research. Deployment and extension of
the CTRP Database, which will allow
the NCI to consolidate reporting,
aggregate information and reduce
redundant submissions, is an
infrastructure development project that
will be enabled by public funds
expended pursuant to the American
Recovery and Reinvestment Act of 2009,
Public Law 111–5 (‘‘Recovery Act’’).
This information collection adheres to
The Public Health Service Act, Section
407(a)(4) (codified at 42 USC 285a2(a)(2)(D)), which authorizes and
requires the NCI to collect, analyze and
disseminate all data useful in the
prevention, diagnosis, and treatment of
cancer, including the establishment of
an international cancer research data
bank to collect, catalog, store, and
disseminate insofar as feasible the
results of cancer research undertaken in
any country for the use of any person
E:\FR\FM\09NON1.SGM
09NON1
57685
Federal Register / Vol. 74, No. 215 / Monday, November 9, 2009 / Notices
involved in cancer research in any
country. Frequency of Response: Once
per initial trial registration; four
amendments per trial annually; and four
accrual updates per trial annually.
Affected Public: Individuals, business
and other for-profits, and not-for-profit
institutions. Type of Respondents:
Clinical research administrators on
behalf of clinical investigators. The
annual reporting burden is estimated at
38,500 hours.
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
A.12–1—ESTIMATES OF ANNUAL BURDEN HOURS
Survey
instrument
Clinical Trials .....................................
Initial Registration .............................
Amendment ......................................
Accrual Updates ...............................
5,500
5,500
5,500
Total ...........................................
mstockstill on DSKH9S0YB1PROD with NOTICES
Type of respondents
......................................................
16,500
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) Evaluate 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) Evaluate 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) Enhance 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.
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 John Speakman,
Associate Director for Clinical Trials
Products and Programs, Center for
Biomedical Informatics and Information
Technology, National Cancer Institute,
NIH, DHHS, 2115 E. Jefferson Street,
Suite 6000, Rockville, MD 20892 or call
non-toll-free number 301–451–8786 or
e-mail your request, including your
address to: john.speakman@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 30, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E9–26875 Filed 11–6–09; 8:45 am]
BILLING CODE 4140–01–P
VerDate Nov<24>2008
16:52 Nov 06, 2009
Jkt 220001
Number of
respondents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0233]
Guidance for Industry: Use of Nucleic
Acid Tests to Reduce the Risk of
Transmission of West Nile Virus from
Donors of Whole Blood and Blood
Components Intended for Transfusion;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Use of Nucleic
Acid Tests to Reduce the Risk of
Transmission of West Nile Virus from
Donors of Whole Blood and Blood
Components Intended for Transfusion,’’
dated November 2009. This guidance is
intended for establishments that collect
Whole Blood and blood components
intended for transfusion. The document
provides recommendations for testing of
donations of Whole Blood and blood
components for West Nile Virus (WNV)
using an FDA-licensed donor screening
assay. FDA believes that the use of a
licensed nucleic acid test (NAT) will
reduce the risk of transmission of WNV,
and therefore recommends use of a
licensed NAT to screen donors of Whole
Blood and blood components intended
for transfusion. The guidance
announced in this notice finalizes the
recommendations as to Whole Blood
and blood components contained in the
draft guidance ‘‘Guidance for Industry:
Use of Nucleic Acid Tests to Reduce the
Risk of Transmission of West Nile Virus
from Donors of Whole Blood and Blood
Components Intended for Transfusion
and Donors of Human Cells, Tissues,
and Cellular and Tissue-Based Products
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Frequency of
response
1
4
4
Average time
per response
(minutes/
hours)
120/60
60/60
15/60
Annual burden
hours
11,000.
22,000.
5,500.
38,500.
(HCT/Ps),’’ dated April 2008. The
recommendations as to HCT/P donor
specimens contained in the draft
guidance are not being finalized at this
time because FDA believes additional
public discussion is warranted.
DATES: Submit electronic or written
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The guidance may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
´
Denise Sanchez, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry: Use of Nucleic Acid Tests to
Reduce the Risk of Transmission of
West Nile Virus from Donors of Whole
Blood and Blood Components Intended
for Transfusion,’’ dated November 2009.
The guidance document provides
E:\FR\FM\09NON1.SGM
09NON1
]]>Agencies
[Federal Register Volume 74, Number 215 (Monday, November 9, 2009)]
[Notices]
[Pages 57684-57685]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26875]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Clinical Trials Reporting
Program (CTRP) Database (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: Clinical Trials Reporting Program
(CTRP) Database. Type of Information Collection Request: Revision of
currently approved collection [OMB No. 0925-0600, expiration date 01/
31/2010]. Need and Use of Information Collection: The NCI is developing
an electronic resource, the NCI Clinical Trials Reporting Program
(CTRP) Database, to serve as a single, definitive source of information
about all NCI-supported clinical research, thereby enabling the NCI to
execute its mission to reduce the burden of cancer and to ensure an
optimal return on the nation's investment in cancer clinical research.
Information will be submitted by clinical research administrators as
designees of clinical investigators who conduct NCI-supported clinical
research. Deployment and extension of the CTRP Database, which will
allow the NCI to consolidate reporting, aggregate information and
reduce redundant submissions, is an infrastructure development project
that will be enabled by public funds expended pursuant to the American
Recovery and Reinvestment Act of 2009, Public Law 111-5 (``Recovery
Act''). This information collection adheres to The Public Health
Service Act, Section 407(a)(4) (codified at 42 USC 285a-2(a)(2)(D)),
which authorizes and requires the NCI to collect, analyze and
disseminate all data useful in the prevention, diagnosis, and treatment
of cancer, including the establishment of an international cancer
research data bank to collect, catalog, store, and disseminate insofar
as feasible the results of cancer research undertaken in any country
for the use of any person
[[Page 57685]]
involved in cancer research in any country. Frequency of Response: Once
per initial trial registration; four amendments per trial annually; and
four accrual updates per trial annually. Affected Public: Individuals,
business and other for-profits, and not-for-profit institutions. Type
of Respondents: Clinical research administrators on behalf of clinical
investigators. The annual reporting burden is estimated at 38,500
hours.
There are no Capital Costs, Operating Costs, and/or Maintenance
Costs to report.
A.12-1--Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Average time
Survey Number of Frequency of per response Annual burden
Type of respondents instrument respondents response (minutes/ hours
hours)
----------------------------------------------------------------------------------------------------------------
Clinical Trials............... Initial 5,500 1 120/60 11,000.
Registration.
Amendment....... 5,500 4 60/60 22,000.
Accrual Updates. 5,500 4 15/60 5,500.
---------------------------------------------------------------------------------
Total..................... ................ 16,500 .............. .............. 38,500.
----------------------------------------------------------------------------------------------------------------
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) Evaluate 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) Evaluate 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) Enhance 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.
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 John Speakman, Associate Director for Clinical
Trials Products and Programs, Center for Biomedical Informatics and
Information Technology, National Cancer Institute, NIH, DHHS, 2115 E.
Jefferson Street, Suite 6000, Rockville, MD 20892 or call non-toll-free
number 301-451-8786 or e-mail your request, including your address to:
john.speakman@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 30, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E9-26875 Filed 11-6-09; 8:45 am]
BILLING CODE 4140-01-P
