Submission for OMB Review; Comment Request: STAR METRICS (Science and Technology for America's Reinvestment: Measuring the EffecTs of Research on Innovation, Competitiveness and Science), 11135-11136 [2012-4271]
Download as PDF
<![CDATA[
11135
Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. 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. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
control numbers 0910–0636 and 0910–
0635.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://www.fda.
gov/BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://www.fda.
gov/MedicalDevices/DeviceRegulation
andGuidance/GuidanceDocuments/
default.htm, https://www.fda.gov/Food/
GuidanceComplianceRegulatory
Information/GuidanceDocuments/
default.htm, or https://
www.regulations.gov.
Dated: February 17, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
III. The Paperwork Reduction Act of
1995
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collection of information in
this guidance was approved under OMB
control number 0910–0701.
The guidance also refers to previously
approved collections of information
found in FDA’s adverse event reporting
requirements in 21 CFR 310.305, 314.80,
314.98, 600.80, 606.170, 640.73,
1271.350, and 21 CFR part 803. These
regulations contain collections of
information that are subject to review by
OMB under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520) and
are approved under OMB control
numbers 0910–0116, 0910–0291, 0910–
0230, 0910–0308, 0910–0437, and 0910–
0543. In addition, the guidance also
refers to adverse event reports for
nonprescription human drug products
marketed without an approved
application and dietary supplements
required under sections 760 and 761 of
the FD&C Act (21 U.S.C. 379aa and
379aa–1), which include collections of
information approved under OMB
[FR Doc. 2012–4288 Filed 2–23–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request: STAR METRICS
(Science and Technology for
America’s Reinvestment: Measuring
the EffecTs of Research on Innovation,
Competitiveness and Science)
Summary: Under the provisions of
section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Director, 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 Oct 5, 2011 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 October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection: Title: STAR
METRICS (Science and Technology for
America’s Reinvestment: Measuring the
EffecTs of Research on Innovation,
Competitiveness and Science). Type of
Information Collection Request:
Extension of OMB number 0925–0616,
expiration date 03/31/2012. Need and
Use of Information Collection: The aim
of STAR METRICS is twofold. The goal
of STAR METRICS is to continue to
provide mechanisms that will allow
participating universities and Federal
agencies with a reliable and consistent
means to account for the number of
scientists and staff that are on research
institution payrolls, supported by
federal funds. In subsequent generations
of the program, it is hoped that STAR
METRICS will allow for measurement of
science impact on economic outcomes
(such as job creatfon), on knowledge
generation (such as citations, and
patents) as well as on social and health
outcomes.
Frequency of Response: Quarterly.∼
Affected Public: Universities and
other research institutions.
Type of Respondents: University
administrators.
The annual reporting burden is as
follows:
Estimated Number of Respondent:
100.
Estimated Number of Responses per
Respondent: 4.
Average Burden Hours per Response:
2.5.
Estimated Total Annual Burden
Hours Requested: 1,315.
The annualized cost to respondents is
estimated to be $65,750. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
A.12–1—ESTIMATES OF ANNUAL BURDEN HOURS
Number of
respondents
Average time
per response
(in hours)
Frequency
of response
Annual hour
burden
srobinson on DSK4SPTVN1PROD with NOTICES
Stage I: One time data input ...........................................................................
Stage 2: Ongoing quarterly data input ............................................................
7
100
1
4
45
2.5
315
1,000
Total ..........................................................................................................
........................
........................
........................
1,315
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
VerDate Mar<15>2010
18:34 Feb 23, 2012
Jkt 226001
(1) Whether the proposed collection of
information is necessary for the proper
performance of the functioning of the
National Cancer Institute, including
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
whether the information will have
practical utility; (2) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
E:\FR\FM\24FEN1.SGM
24FEN1
11136
Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices
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 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
to obtain a copy of the data collection
plans and instruments, contact: George
Chacko, Office of Planning, Analysis,
and Evaluation, Center for Scientific
Review, 6701 Rockledge Drive, Suite
3030, Bethesda, MD 20892 or call nontoll-free at 301–435–1111 or email your
request, including your address to:
chackoge@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.
George Chacko,
Director, Office of Planning, Analysis, and
Evaluation, Center for Scientific Review,
National Institutes of Health.
[FR Doc. 2012–4271 Filed 2–23–12; 8:45 am]
BILLING CODE 4104–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; a Multi-Center International
Hospital-Based Case-Control Study of
Lymphoma in Asia (AsiaLymph) (NCI)
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: A MultiCenter International Hospital-Based
Case-Control Study of Lymphoma in
Asia (AsiaLymph) (NCI). Type of
Information Collection Request:
Emergency. 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
novel findings from epidemiological
studies conducted in the United States
that have attempted to explain this
increase. However, none of the chemical
associations have been conclusively
established and the identification of the
key, functional alleles in gene regions
associated with risk of NHL requires
further elucidation. Further, the ability
to follow-up, confirm, and extend these
observations in the United States is
limited by the low prevalence and
limited range of several important
chemical and viral exposures and the
high to complete linkage disequilibrium
among key candidate genetic loci in
Western populations. To optimize the
ability to build on and clarify these
findings, it is necessary to investigate
populations that differ from those in the
SUMMARY:
West in both exposure patterns and
underlying genetic structure. A
multidisciplinary case-control study of
lymphoma in Asia, where lymphoma
rates have also risen, provides an
opportunity to replicate and extend
recent and novel observations made in
studies in the West in a population that
is distinctly different with regard to
patterns of key risk factors, including
range of exposures, prevalence of
exposures, correlations between
exposures, and variation in gene regions
of particular interest. It will also
improve the ability to understand the
causes of certain types of rare
lymphoma tumors in the United States
that occur at much higher rates in Asia.
As such, AsiaLymph will confirm and
extend previous findings and yield
novel insights into the causes of
lymphoma in both Asia and in the
United States. The major postulated risk
factors for evaluation in this study are
chemical exposures (i.e.,
organochlorines, trichloroethylene, and
benzene) and genetic susceptibility.
Other factors potentially related to
lymphoma, such as viral infections,
ultraviolet radiation exposure, medical
conditions, and other lifestyle factors
will also be studied. Patients from 19
participating hospitals will 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 .........................................
srobinson on DSK4SPTVN1PROD with NOTICES
Category of respondents
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
1,102
Total ...........................................
...........................................................
........................
........................
........................
5,302
VerDate Mar<15>2010
18:34 Feb 23, 2012
Jkt 226001
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
E:\FR\FM\24FEN1.SGM
24FEN1
]]>Agencies
[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Notices]
[Pages 11135-11136]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4271]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request: STAR METRICS (Science
and Technology for America's Reinvestment: Measuring the EffecTs of
Research on Innovation, Competitiveness and Science)
Summary: Under the provisions of section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995, the Office of the Director, 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 Oct 5, 2011 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
October 1, 1995, unless it displays a currently valid OMB control
number.
Proposed Collection: Title: STAR METRICS (Science and Technology
for America's Reinvestment: Measuring the EffecTs of Research on
Innovation, Competitiveness and Science). Type of Information
Collection Request: Extension of OMB number 0925-0616, expiration date
03/31/2012. Need and Use of Information Collection: The aim of STAR
METRICS is twofold. The goal of STAR METRICS is to continue to provide
mechanisms that will allow participating universities and Federal
agencies with a reliable and consistent means to account for the number
of scientists and staff that are on research institution payrolls,
supported by federal funds. In subsequent generations of the program,
it is hoped that STAR METRICS will allow for measurement of science
impact on economic outcomes (such as job creatfon), on knowledge
generation (such as citations, and patents) as well as on social and
health outcomes.
Frequency of Response: Quarterly.~
Affected Public: Universities and other research institutions.
Type of Respondents: University administrators.
The annual reporting burden is as follows:
Estimated Number of Respondent: 100.
Estimated Number of Responses per Respondent: 4.
Average Burden Hours per Response: 2.5.
Estimated Total Annual Burden Hours Requested: 1,315.
The annualized cost to respondents is estimated to be $65,750.
There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report.
A.12-1--Estimates Of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Average time
Number of Frequency of per response Annual hour
respondents response (in hours) burden
----------------------------------------------------------------------------------------------------------------
Stage I: One time data input.................... 7 1 45 315
Stage 2: Ongoing quarterly data input........... 100 4 2.5 1,000
---------------------------------------------------------------
Total....................................... .............. .............. .............. 1,315
----------------------------------------------------------------------------------------------------------------
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 functioning of the National
Cancer Institute, 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,
[[Page 11136]]
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 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 to obtain a copy of
the data collection plans and instruments, contact: George Chacko,
Office of Planning, Analysis, and Evaluation, Center for Scientific
Review, 6701 Rockledge Drive, Suite 3030, Bethesda, MD 20892 or call
non-toll-free at 301-435-1111 or email your request, including your
address to: chackoge@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.
George Chacko,
Director, Office of Planning, Analysis, and Evaluation, Center for
Scientific Review, National Institutes of Health.
[FR Doc. 2012-4271 Filed 2-23-12; 8:45 am]
BILLING CODE 4104-01-P
