Submission for OMB Review; Comment Request: Process Evaluation of the Early Independence Award (EIA) Program, 56853-56854 [2012-22741]
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Federal Register / Vol. 77, No. 179 / Friday, September 14, 2012 / Notices
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
IV. Comments
Submission for OMB Review;
Comment Request: Process Evaluation
of the Early Independence Award (EIA)
Program
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments on any of the specific BE
recommendations posted on FDA’s Web
site. It is only necessary to send one set
of comments. Identify comments with
the docket number found in brackets in
the heading of this document. The
guidances, notices, and received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: September 4, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–22658 Filed 9–13–12; 8:45 am]
BILLING CODE 4160–01–P
National Institutes of Health
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of
Strategic Coordination (OSC), Division
of Program Coordination, Planning, and
Strategic Initiatives (DPCPSI), the
National Institutes of Health (NIH), has
submitted to the Office of Management
and Budget (OMB) a request to review
and approve the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on June 13, 2012
(Vol. 77, No 114, Page 35408), 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 NIH 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 October 1,
1995, unless it displays a currently valid
OMB control number.
Proposed Collection: Title: Process
Evaluation of the Early Independence
SUMMARY:
Award (EIA) Program. Type of
Information Collection Request: NEW.
Need and Use of Information Collection:
This study will assess the EIA program
operations. The primary objectives of
the study are to: (1) Assess if the
Requests for Applications (RFAs) are
meeting the needs of applicants; (2)
document the selection process; (3)
document EIA program operations; (4)
assess the progress being made by the
Early Independence Principal
Investigators; and (5) assess the support
provided by the Host Institutions to the
Early Independence Principal
Investigators. The findings will provide
valuable information concerning: (1)
Aspects of the program that could be
revised or improved; (2) progress made
by the Early Independence Principal
Investigators; and (3) implementation of
the program at Host Institutions.
Frequency of Response: On occasion.
Affected Public: None. Type of
Respondents: Applicants, reviewers,
and awardees. The annual reporting
burden is as follows: Estimated Number
of Respondents: 390; Estimated Number
of Responses per Respondent: 1;
Average Burden Hours per Response: .4;
and Estimated Total Annual Burden
Hours Requested: 158. The annualized
cost to respondents is estimated at
$9,774. There are no Capital Costs to
report.
A.12.1—ANNUALIZED ESTIMATE OF HOUR BURDEN
Number of
respondents
Type of respondents
Average time
per response
(in hrs.)
Frequency
of response
Annual hour
burden
15
150
150
1
1
1
15/60
15/60
15/60
4
38
38
12
1
30/60
6
12
1
1
12
24
1
1
24
12
1
1
12
24
1
1
24
Total ..........................................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Editorial Board Reviewers (paper survey) .......................................................
Applicants—Junior Scientists (online survey) ..................................................
Applicants—Officials of Host Institutions (online survey) ................................
Awardees—Early Independence Principal Investigator (paper survey—beginning of 1st year of award) .......................................................................
Awardees—Early Independence Principal Investigator (phone interview—
end of 1st year of award) .............................................................................
Awardees—Early Independence Principal Investigator (online survey—end
of 2nd and 3rd year of award) .....................................................................
Awardees—Point of Contact at Host Institution (phone interview—end of 1st
year of award) ..............................................................................................
Awardees—Point of Contact at Host Institution (online survey—end of 2nd
and 3rd year of award) ................................................................................
........................
........................
........................
158
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address 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
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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
PO 00000
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Fmt 4703
Sfmt 4703
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
E:\FR\FM\14SEN1.SGM
14SEN1
56854
Federal Register / Vol. 77, No. 179 / Friday, September 14, 2012 / Notices
instruments, contact Dr. Ravi
Basavappa, OSC, DPCPSI, Office of the
Director, NIH, 1 Center Drive, MSC
0189, Building 1, Room 203, Bethesda,
MD 20892–0189; telephone 301–594–
8190; fax 301–435–7268; or email your
request, including your address, to
earlyindependence@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: September 7, 2012.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2012–22741 Filed 9–13–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request: A Multi-Center
International Hospital-Based CaseControl Study of Lymphoma in Asia
(AsiaLymph) (NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute (NCI), the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
SUMMARY:
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on February 24, 2012 (77 FR
11136) and allowed 60 days for public
comment. There was one public
comment that was not relevant to the
scope, methodology, or burden of the
study. The program staff submitted a
response to the public comment. 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 October 1, 1995, unless it
displays a currently valid OMB control
number.
Proposed Collection: Title: A MultiCenter International Hospital-Based
Case-Control Study of Lymphoma in
Asia (AsiaLymph) (NCI) (OMB No.
0925–0654). Type of Information
Collection Request: Extension. Need and
Use of Information Collection: Incidence
rates of certain lymphomas have
increased in the United States and in
many other parts of the world. The
contribution of environmental,
occupational, and genetic factors to the
cause of lymphoma has generated a
series of new findings from
epidemiological studies conducted in
the United States that have attempted to
explain this increase. This study focuses
on collecting critically needed
information to understand and reduce
the cancer burden from lymphoid
malignancies in the Asian population,
the incidence of which has risen in
recent decades. Specifically,
environmental exposures to industrial
emissions, genetic susceptibility, viral
exposures, early life exposures,
ultraviolet (UV) radiation exposures,
and other risk factors for lymphoma
overall and specifically for populations
in Asia will be examined. Patients from
19 participating hospitals will continue
to be screened and enrolled. There will
be a one-time computer-administered
interview, and patients will also be
asked to provide a one-time blood and
buccal cell mouth wash sample and
lymphoma cases will be asked to make
available a portion of their pathology
sample. Frequency of Response: Once.
Affected Public: Individuals. Type of
Respondents: Newly diagnosed patients
with lymphoma or patients undergoing
surgery or other treatment for noncancer related medical issues who live
in Taiwan and in Hong Kong, Chengdu
and Tianjin, China will be enrolled at
treating hospitals. The annual reporting
burden is estimated at 5,302 hours (see
Table below). There are $77,000 in
Capital Costs, Operating Costs, and/or
Maintenance Costs to report.
ESTIMATES OF ANNUAL BURDEN HOURS
Number of
respondents
Frequency of
response
Average time
per response
(minutes/hour)
Annual
burden hours
Types of respondents
Individuals ..........................................
Patients to be Screened ..................
Patients with Lymphoma .................
Other Patients ..................................
Study Pathologists ...........................
Interviewers ......................................
3,100
1,100
1,100
19
19
1
1
1
58
116
5/60
105/60
105/60
5/60
30/60
258
1,925
1,925
92
1102
Total ...........................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Category of respondents
..........................................................
........................
........................
........................
5,302
Request For Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proposed performance of the
functions of the agency, including
whether the information may have
practical utility; (2) The accuracy of the
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
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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 and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the
Attention: NIH Desk Officer, Office of
Management and Budget, at
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. To request more
information on the proposed project or
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to obtain a copy of the data collection
plans, contact Nathaniel Rothman,
Senior Investigator for the Occupational
and Environmental Epidemiology
Branch, Division of Epidemiology and
Genetics, National Cancer Institute,
6120 Executive Boulevard, Room 8118,
Rockville, MD 20892 or call non-tollfree number 301–496–9093 or email
your request, including your address to:
rothmann@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
E:\FR\FM\14SEN1.SGM
14SEN1
]]>Agencies
[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Notices]
[Pages 56853-56854]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22741]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request: Process Evaluation of
the Early Independence Award (EIA) Program
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of Strategic Coordination (OSC),
Division of Program Coordination, Planning, and Strategic Initiatives
(DPCPSI), the National Institutes of Health (NIH), has submitted to the
Office of Management and Budget (OMB) a request to review and approve
the information collection listed below. This proposed information
collection was previously published in the Federal Register on June 13,
2012 (Vol. 77, No 114, Page 35408), 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 NIH 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 October 1, 1995, unless it displays a currently
valid OMB control number.
Proposed Collection: Title: Process Evaluation of the Early
Independence Award (EIA) Program. Type of Information Collection
Request: NEW. Need and Use of Information Collection: This study will
assess the EIA program operations. The primary objectives of the study
are to: (1) Assess if the Requests for Applications (RFAs) are meeting
the needs of applicants; (2) document the selection process; (3)
document EIA program operations; (4) assess the progress being made by
the Early Independence Principal Investigators; and (5) assess the
support provided by the Host Institutions to the Early Independence
Principal Investigators. The findings will provide valuable information
concerning: (1) Aspects of the program that could be revised or
improved; (2) progress made by the Early Independence Principal
Investigators; and (3) implementation of the program at Host
Institutions. Frequency of Response: On occasion. Affected Public:
None. Type of Respondents: Applicants, reviewers, and awardees. The
annual reporting burden is as follows: Estimated Number of Respondents:
390; Estimated Number of Responses per Respondent: 1; Average Burden
Hours per Response: .4; and Estimated Total Annual Burden Hours
Requested: 158. The annualized cost to respondents is estimated at
$9,774. There are no Capital Costs to report.
A.12.1--Annualized Estimate of Hour Burden
----------------------------------------------------------------------------------------------------------------
Average time
Type of respondents Number of Frequency of per response Annual hour
respondents response (in hrs.) burden
----------------------------------------------------------------------------------------------------------------
Editorial Board Reviewers (paper survey)........ 15 1 15/60 4
Applicants--Junior Scientists (online survey)... 150 1 15/60 38
Applicants--Officials of Host Institutions 150 1 15/60 38
(online survey)................................
Awardees--Early Independence Principal 12 1 30/60 6
Investigator (paper survey--beginning of 1st
year of award).................................
Awardees--Early Independence Principal 12 1 1 12
Investigator (phone interview--end of 1st year
of award)......................................
Awardees--Early Independence Principal 24 1 1 24
Investigator (online survey--end of 2nd and 3rd
year of award).................................
Awardees--Point of Contact at Host Institution 12 1 1 12
(phone interview--end of 1st year of award)....
Awardees--Point of Contact at Host Institution 24 1 1 24
(online survey--end of 2nd and 3rd year of
award).........................................
---------------------------------------------------------------
Total....................................... .............. .............. .............. 158
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address 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
[[Page 56854]]
instruments, contact Dr. Ravi Basavappa, OSC, DPCPSI, Office of the
Director, NIH, 1 Center Drive, MSC 0189, Building 1, Room 203,
Bethesda, MD 20892-0189; telephone 301-594-8190; fax 301-435-7268; or
email your request, including your address, to
earlyindependence@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
Dated: September 7, 2012.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2012-22741 Filed 9-13-12; 8:45 am]
BILLING CODE 4140-01-P
