Submission for OMB Review; Comment Request; Recruitment and Screening for the Insight Into Determination of Exceptional Aging and Longevity (IDEAL) Study, 77881-77882 [2010-31376]
Download as PDF
<![CDATA[
77881
Federal Register / Vol. 75, No. 239 / Tuesday, December 14, 2010 / Notices
consequences are largely unknown due
to insufficient research in this area.
Participants will be recruited from
across job/exposure groups of primarily
English, Spanish, or Vietnamese
speaking adults (accommodations for
other languages developed as
appropriate) who performed oil-spill
clean-up-related work (‘‘exposed’’) and
similar persons who did not
(‘‘unexposed’’ controls), and followed in
either an Active Follow-up Cohort
(N∼27,000) or a Passive Follow-up
Cohort (N∼28,000). Exposures will be
estimated using detailed job-exposure
matrices developed from data from
monitoring performed by different
agencies and organizations during the
crisis, information obtained by
interview, and the available scientific
literature. We will investigate acute
health effects among all cohort members
via self-report from the enrollment
interview, and via clinical measures and
biological samples from Active Followup Cohort members only. All cohort
members will be followed for
development of a range of health
outcomes through record linkage (e.g.,
cancer, mortality) and possibly through
linkage with routinely collected health
surveillance data (collected by health
departments and the CDC) or with
electronic medical records. Recruitment
of subjects should begin in late 2010,
with telephone interviews and the
baseline home visits conducted within
18 months.
Estimated
number of
respondents
Estimated
responses per
respondent
Burden hours
per response
Total burden
hours per
respondent
Estimated
total burden
hours
Ineligible respondents ..........................................................
Enrollment interview (All) .....................................................
Home Visit (Active) ..............................................................
Annual Contact Info Update (Passive) ................................
Annual Contact Info Update (Active) ...................................
Biennial interview (Active) ....................................................
Passive Cohort Total responses & hrs .........................
Active Cohort Total responses & hrs ...........................
TOTAL responses & avg hrs per response ..........
Average per year ............................................
srobinson on DSKHWCL6B1PROD with NOTICES
Activity (3-yrs)
25,000
55,000
27,000
28,000
27,000
27,000
........................
........................
........................
........................
1
1
1
3
2
1
4
5
9
........................
0.25
0.50
2.75
0.25
0.25
0.50
........................
........................
........................
........................
0.25
0.50
2.75
0.75
0.50
0.50
1.25
4.25
0.58
........................
6,250
27,500
74,250
21,000
13,500
13,500
........................
........................
156,000
52,000
Frequency of Response: Participation
will include one enrollment telephone
interview (0.5 hr); collection of
biological and environmental samples,
basic clinical measurements, and GPS
coordinates (2.75 hr) from the Active
Follow-up Cohort only; annual contact
information update (0.25; Active and
Passive) or biennial follow-up telephone
or Web interviews (0.5 hr; Active only)
for 10 years or more. We also anticipate
screening 25,000 ineligible respondents.
Affected Public: Individuals or
households. Type of Respondents:
Workers involved in Deepwater Horizon
disaster clean-up, and similar
individuals not involved in clean-up
effort. The annual reporting burden is as
follows: Estimated Number of
Respondents: Active Follow-up Cohort
(N∼27,000) and Passive Follow-up
Cohort (N∼28,000).
Estimated Number of Responses per
Respondent: See table.
Average Burden Hours Per Response:
0.58 hour; and Estimated Total Burden
Hours Requested: 156,000 (over 3 years).
The average annual burden hours
requested is 52,000. The annualized cost
to respondents is estimated at $11.60
(assuming $20 hourly wage × 0.58 hour).
There are no Capital Costs to report.
There are no 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
VerDate Mar<15>2010
17:09 Dec 13, 2010
Jkt 223001
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.
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: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the project or to obtain
a copy of the data collection plans and
instruments, contact: Dr. Dale P.
Sandler, Chief, Epidemiology Branch,
NIEHS, Rall Building A3–05, PO Box
12233, Research Triangle Park, NC
27709; non-toll-free number 919–541–
4668 or e-mail sandler@niehs.nih.gov.
Include your address.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
received within 30 days of the date of
this publication.
Dated: December 9, 2010.
W. Christopher Long,
NIEHS, Acting Associate Director for
Management, National Institutes of Health.
[FR Doc. 2010–31377 Filed 12–13–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Recruitment and
Screening for the Insight Into
Determination of Exceptional Aging
and Longevity (IDEAL) Study
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute on Aging (NIA), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on September 17,
2010, page 57038 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
SUMMARY:
E:\FR\FM\14DEN1.SGM
14DEN1
77882
Federal Register / Vol. 75, No. 239 / Tuesday, December 14, 2010 / Notices
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: Recruitment and Screening for
the Insight into Determination of
Exceptional Aging and Longevity
(IDEAL) Study. Type of Information
Collection Request: NEW. Need and Use
of Information Collection: The purpose
of the project is to conduct recruitment
and screening for the IDEAL Study. A
multifaceted recruitment approach will
be used to reach the target audience in
a wide variety of ways. Those who are
interested in participating in the IDEAL
study will be asked to complete a two
stage recruitment process consisting of a
telephone interview and a physical
exam. The Stage One interview consists
of questions concerning demographics,
physical ability, health status, and
medical conditions. Those who are
eligible after completing the telephone
interview will be asked to complete the
second stage of the screening process.
The physical examination is a modified
version of the full BLSA assessment
protocol consisting of the following
components: General appearance; vital
signs; chest and heart auscultation;
sensory systems including vision,
hearing, sensory proprioception,
neuropathy and balance; and movement
and strength of the upper and lower
extremities. In addition the potential
Number of
respondents
Type of respondent
participant will also be asked to
complete physical performance tests,
cognitive exams, an electrocardiogram
and a blood draw. Frequency of
Response: Once. Affected Public:
Individuals or households. Type of
Respondents: Healthy individuals who
are at least 80 years of age. The annual
reporting burden is as follows:
Estimated Number of Respondents:
1,500; Estimated Number of Responses
per Respondent: 1; Average Burden
Hours per Response: 0.833; and
Estimated Total Annual Burden Hours
Requested: 701. There is no annualized
cost to respondents. There are no
Capital costs to report. There are no
Operating or Maintenance Costs to
report.
Frequency of
response
Average time
per response
Annual hour
burden
Individuals who complete the phone interview ..............................................
Individuals who complete the physical exam ................................................
1,500
*300
1
1
0.167
1.5
251
450
Totals ..................................................................................................
1,500
........................
..........................
701
srobinson on DSKHWCL6B1PROD with NOTICES
*These individuals are included in the 1,500 above.
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.
Direct Comments to OMB: Written
comments and or suggestions regarding
the item(s) contained in the notice,
especially regarding the estimated
public burden and associated response
time should be directed to the: Office of
Management and Budget, Office of
Regulatory Affairs, OIRA
submission@omb.eop.gov or by fax to
202–395–6974. Attention: Desk Officer
for NIH. To request more information on
the proposed project or obtain a copy of
the data collection plans and
instruments, contact Dr. Luigi Ferrucci,
Principal Investigator, NIA Clinical
Research Branch, Harbor Hospital, 5th
VerDate Mar<15>2010
17:09 Dec 13, 2010
Jkt 223001
Floor, 3001 S. Hanover, Baltimore, MD
21225, or call this non-toll-free number
(410) 350–3936 or E-mail your request
including your address to:
Ferruccilu@grc.nia.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: December 6, 2010.
Melissa Fraczkowski,
Project Clearance Liaison, NIA.
[FR Doc. 2010–31376 Filed 12–13–10; 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:
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
inventions to extend market coverage
SUMMARY:
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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.
Software System for Quantitative
Assessment of Vasculature in Three
Dimensional Images
Description of Invention: This
invention offered for licensing and
further development is a software
system that provides the capability of
efficiently extracting, visualizing and
quantifying three dimensional vascular
networks from medical and basic
research images. Deregulation of
angiogenesis plays a major role in a
number of human diseases, most
notably cancer. A substantial increase in
the research effort in this field over the
past decade has deepened the
understanding of the angiogenic
process. However, the lack of methods
and software to quantitatively assess
vasculature in patients has considerably
hampered the ability to directly study
the angiogenesis process, as well as to
discover and develop new therapeutics
to modulate angiogenesis. The present
E:\FR\FM\14DEN1.SGM
14DEN1
]]>Agencies
[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Notices]
[Pages 77881-77882]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31376]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Recruitment and
Screening for the Insight Into Determination of Exceptional Aging and
Longevity (IDEAL) Study
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute on Aging (NIA), the
National Institutes of Health (NIH) has submitted to the Office of
Management and Budget (OMB) a request for review and approval of the
information collection listed below. This proposed information
collection was previously published in the Federal Register on
September 17, 2010, page 57038 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
[[Page 77882]]
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: Recruitment and Screening for the Insight into Determination
of Exceptional Aging and Longevity (IDEAL) Study. Type of Information
Collection Request: NEW. Need and Use of Information Collection: The
purpose of the project is to conduct recruitment and screening for the
IDEAL Study. A multifaceted recruitment approach will be used to reach
the target audience in a wide variety of ways. Those who are interested
in participating in the IDEAL study will be asked to complete a two
stage recruitment process consisting of a telephone interview and a
physical exam. The Stage One interview consists of questions concerning
demographics, physical ability, health status, and medical conditions.
Those who are eligible after completing the telephone interview will be
asked to complete the second stage of the screening process. The
physical examination is a modified version of the full BLSA assessment
protocol consisting of the following components: General appearance;
vital signs; chest and heart auscultation; sensory systems including
vision, hearing, sensory proprioception, neuropathy and balance; and
movement and strength of the upper and lower extremities. In addition
the potential participant will also be asked to complete physical
performance tests, cognitive exams, an electrocardiogram and a blood
draw. Frequency of Response: Once. Affected Public: Individuals or
households. Type of Respondents: Healthy individuals who are at least
80 years of age. The annual reporting burden is as follows: Estimated
Number of Respondents: 1,500; Estimated Number of Responses per
Respondent: 1; Average Burden Hours per Response: 0.833; and Estimated
Total Annual Burden Hours Requested: 701. There is no annualized cost
to respondents. There are no Capital costs to report. There are no
Operating or Maintenance Costs to report.
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time Annual hour
Type of respondent respondents response per response burden
----------------------------------------------------------------------------------------------------------------
Individuals who complete the phone interview.... 1,500 1 0.167 251
Individuals who complete the physical exam...... *300 1 1.5 450
---------------------------------------------------------------
Totals.................................... 1,500 .............. .............. 701
----------------------------------------------------------------------------------------------------------------
*These individuals are included in the 1,500 above.
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.
Direct Comments to OMB: Written comments and or suggestions
regarding the item(s) contained in the notice, especially regarding the
estimated public burden and associated response time should be directed
to the: Office of Management and Budget, Office of Regulatory Affairs,
OIRA submission@omb.eop.gov or by fax to 202-395-6974. Attention: Desk
Officer for NIH. To request more information on the proposed project or
obtain a copy of the data collection plans and instruments, contact Dr.
Luigi Ferrucci, Principal Investigator, NIA Clinical Research Branch,
Harbor Hospital, 5th Floor, 3001 S. Hanover, Baltimore, MD 21225, or
call this non-toll-free number (410) 350-3936 or E-mail your request
including your address to: Ferruccilu@grc.nia.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: December 6, 2010.
Melissa Fraczkowski,
Project Clearance Liaison, NIA.
[FR Doc. 2010-31376 Filed 12-13-10; 8:45 am]
BILLING CODE 4140-01-P
