Proposed Collection; 30-Day Comment Request-the Hispanic Community Health Study/Study of Latinos (HCHS/SOL), 34767-34768 [2014-14258]
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34767
Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Notices
cohort PIs for initial completion and
then annually to update any information
that has changed so that the CEDCD
Web site will remain current. No cohort
participant-level data is being collected
from any of the cohorts.
The information to be collected will
be aggregate descriptive information and
protocols. Though the CEDCD has a
biospecimen component (similar to the
Specimen Resource Locator), the
CEDCD is not a biospecimen locator
database. It is a database focusing
exclusively on descriptive data
pertaining to large, prospective
epidemiology cohorts.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
425.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Number of
respondents
Form name
Individual:
Principal Investigator ..................
Initial Submission .......................
Individual:
Principal Investigator ..................
Annual Update ...........................
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
annual
burden
hour
Written Agreement Form .................
Biospecimen Spreadsheet ...............
Descriptive Db Collection Form .......
100
100
100
1
1
1
15/60
1
1
25
100
100
Biospecimen Spreadsheet * .............
Descriptive Db Collection Form * .....
200
200
1
1
30/60
30/60
100
100
* All forms will be prepopulated with the information that was entered initially.
Dated: June 12, 2014.
Karla Bailey,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2014–14275 Filed 6–17–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 30-Day Comment
Request—the Hispanic Community
Health Study/Study of Latinos (HCHS/
SOL)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, 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 March 25, 2014
(Vol. 79, No. 57, pages 16345–16347). 3
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Heart, Lung and Blood
Institute (NHLBI), 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.
Direct Comments to OMB: Written
comments and/or suggestions regarding
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:35 Jun 17, 2014
Jkt 232001
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: NIH Desk Officer.
DATES: Comment 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.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact either: Dr. Larissa Aviles-Santa,
6701 Rockledge, Epidemiology Branch,
Program in Prevention and Population
Sciences, Division of Cardiovascular
Sciences, National Heart, Lung, and
Blood Institute, National Institutes of
Health, 6701 Rockledge Dr., MSC 7936,
Bethesda, MD 20892–7936, or call nontoll-free number 301–435–0450, or
Email your request, including your
address to avilessantal@nhlbi.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: The Hispanic
Community Health Study/Study of
Latinos (HCHS/SOL), Revision, National
Heart, Lung and Blood Institute
(NHLBI), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The purpose and use of the
information collection for this project is
to study the prevalence of
cardiovascular and pulmonary disease
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
and other chronic diseases, and their
risk and protective factors, understand
their relationship to all-cause,
cardiovascular and pulmonary
morbidity and mortality, and
understand the role of sociocultural
factors (including acculturation) on the
prevalence or onset of disease among
over 16,400 Hispanics/Latinos of
diverse origins, aged 18–74 years at
enrollment, living in four U.S.
communities: San Diego, California;
Chicago, Illinois; Miami, Florida, and
the Bronx, New York. In order to
achieve these objectives, the HCHS/SOL
had two integrated components:
1. Examination of the cohort
following a standardized protocol,
which consisted of interviews and
clinical measurements to assess
physiological and biochemical
measurements including DNA/RNA
extraction for ancillary genetic research
studies.
2. Follow-up of the cohort, which
consists of an annual telephone
interview to assess vital status, changes
in health status and medication intake,
and new cardiovascular and pulmonary
events (including fatal and non-fatal
myocardial infarction and heart failure;
fatal and non-fatal stroke; and
exacerbation of asthma and chronic
obstructive pulmonary disease).
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
30,940.
E:\FR\FM\18JNN1.SGM
18JNN1
34768
Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
A.12.1 ESTIMATES OF HOUR BURDEN
[Appendices 11, 14 and 15]
Number of
respondents
Type of respondents
Survey instrument
Participants Visit 2 Examination (Appendices 11 and 14).
Pre-visit
scheduling
&
safety
screening.
Reception, informed consent (Appendix 11), medical releases.
Ppt. disability screening ...................
Ppt. safety update and routing ........
Change clothes, urine specimen .....
Updated personal information .........
Anthropometry .................................
Determination of fasting & blood
draw.
Determination of blood glucose,
OGTT.
Seated BP ........................................
Echocardiography ............................
2-hour blood draw, snack ................
Personal Medical History .................
Reproductive Medical History ..........
Pregnancy Complications History ....
Socio-economic
Status—Occupation.
Health Care Access and Utilization
Chronic Stress .................................
Family Cohesion ..............................
Social Support .................................
Acculturation ....................................
Well Being ........................................
Abbreviated Medication Use ............
Tobacco Use ....................................
Alcohol Use ......................................
Participant Feedback .......................
..........................................................
Total ...........................................
Participants AFU Phone Interview
(Appendix 15).
Total ...........................................
2/60
463
13878
1
20/60
4626
13878
13878
13878
13878
13878
13878
1
1
1
1
1
1
4/60
2/60
10/60
5/60
7/60
11/60
925
463
2313
1157
1619
2544
13878
1
6/60
1388
13878
8000
13878
13878
9000
9000
13878
1
1
1
1
1
1
1
9/60
30/60
12/60
10/60
9/60
6/60
3/60
2082
4000
2776
2313
1350
900
694
13878
13878
13878
13878
13878
13878
13878
13878
13878
13878
1
1
1
1
1
1
1
1
1
1
15/60
4/60
5/60
3/60
3/60
4/60
4/60
7/60
3/60
12/60
3470
925
1157
694
694
463
925
1619
694
2776
........................
........................
206/60
43030
3 ......................................
4 ......................................
5 ......................................
6 ......................................
7 ......................................
8 ......................................
9 ......................................
10 ....................................
11 ....................................
3146
9033
14259
16222
16222
16222
16222
16222
16222
1
1
1
1
1
1
1
1
1
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
15/60
787
2258
3565
4055
4055
4055
4055
4055
4055
..........................................................
........................
........................
120/60
30940
AFU
AFU
AFU
AFU
AFU
AFU
AFU
AFU
AFU
Year
Year
Year
Year
Year
Year
Year
Year
Year
DEPARTMENT OF HOMELAND
SECURITY
United States Immigration and
Customs Enforcement
[FR Doc. 2014–14258 Filed 6–17–14; 8:45 am]
emcdonald on DSK67QTVN1PROD with NOTICES
Total burden
hours
1
Agency Information Collection
Activities: Comment Request;
Extension of an Information Collection
BILLING CODE 4140–01–P
ACTION:
30-Day Notice of Information
Collection for review; Student and
Exchange Visitor Information System
(SEVIS); OMB Control No. 1653–0038.
The Department of Homeland
Security, U.S. Immigration and Customs
Enforcement (USICE), is submitting the
16:35 Jun 17, 2014
Average
time per
response
(in hours)
13878
Dated: June 5, 2014.
Michael Lauer,
Director, DCVS, NHLBI, NIH.
Dated: June 5, 2014.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
VerDate Mar<15>2010
Number of
responses per
respondent
Jkt 232001
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
following information collection request
for review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection is
published in the Federal Register to
obtain comments from the public and
affected agencies. The information
collection was previously published in
the Federal Register on March 28, 2014,
Vol. 79 No. 06903 allowing for a 60 day
comment period. The purpose of this
notice is to allow an additional 30 days
for public comments.
Written comments and suggestions
regarding items contained in this notice
and especially with regard to the
estimated public burden and associated
E:\FR\FM\18JNN1.SGM
18JNN1
Agencies
[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Notices]
[Pages 34767-34768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14258]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 30-Day Comment Request--the Hispanic
Community Health Study/Study of Latinos (HCHS/SOL)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, 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 March 25, 2014 (Vol. 79, No. 57, pages 16345-16347). 3
comments were received. The purpose of this notice is to allow an
additional 30 days for public comment. The National Heart, Lung and
Blood Institute (NHLBI), 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.
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: NIH Desk Officer.
DATES: Comment 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.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments or request more information on the
proposed project contact either: Dr. Larissa Aviles-Santa, 6701
Rockledge, Epidemiology Branch, Program in Prevention and Population
Sciences, Division of Cardiovascular Sciences, National Heart, Lung,
and Blood Institute, National Institutes of Health, 6701 Rockledge Dr.,
MSC 7936, Bethesda, MD 20892-7936, or call non-toll-free number 301-
435-0450, or Email your request, including your address to
avilessantal@nhlbi.nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
Proposed Collection: The Hispanic Community Health Study/Study of
Latinos (HCHS/SOL), Revision, National Heart, Lung and Blood Institute
(NHLBI), National Institutes of Health (NIH).
Need and Use of Information Collection: The purpose and use of the
information collection for this project is to study the prevalence of
cardiovascular and pulmonary disease and other chronic diseases, and
their risk and protective factors, understand their relationship to
all-cause, cardiovascular and pulmonary morbidity and mortality, and
understand the role of sociocultural factors (including acculturation)
on the prevalence or onset of disease among over 16,400 Hispanics/
Latinos of diverse origins, aged 18-74 years at enrollment, living in
four U.S. communities: San Diego, California; Chicago, Illinois; Miami,
Florida, and the Bronx, New York. In order to achieve these objectives,
the HCHS/SOL had two integrated components:
1. Examination of the cohort following a standardized protocol,
which consisted of interviews and clinical measurements to assess
physiological and biochemical measurements including DNA/RNA extraction
for ancillary genetic research studies.
2. Follow-up of the cohort, which consists of an annual telephone
interview to assess vital status, changes in health status and
medication intake, and new cardiovascular and pulmonary events
(including fatal and non-fatal myocardial infarction and heart failure;
fatal and non-fatal stroke; and exacerbation of asthma and chronic
obstructive pulmonary disease).
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 30,940.
[[Page 34768]]
Estimated Annualized Burden Hours
A.12.1 Estimates of Hour Burden
[Appendices 11, 14 and 15]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondents Survey instrument Number of responses per per response Total burden
respondents respondent (in hours) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Participants Visit 2 Examination (Appendices 11 Pre-visit scheduling & safety screening 13878 1 2/60 463
and 14).
Reception, informed consent (Appendix 13878 1 20/60 4626
11), medical releases.
Ppt. disability screening.............. 13878 1 4/60 925
Ppt. safety update and routing......... 13878 1 2/60 463
Change clothes, urine specimen......... 13878 1 10/60 2313
Updated personal information........... 13878 1 5/60 1157
Anthropometry.......................... 13878 1 7/60 1619
Determination of fasting & blood draw.. 13878 1 11/60 2544
Determination of blood glucose, OGTT... 13878 1 6/60 1388
Seated BP.............................. 13878 1 9/60 2082
Echocardiography....................... 8000 1 30/60 4000
2-hour blood draw, snack............... 13878 1 12/60 2776
Personal Medical History............... 13878 1 10/60 2313
Reproductive Medical History........... 9000 1 9/60 1350
Pregnancy Complications History........ 9000 1 6/60 900
Socio-economic Status--Occupation...... 13878 1 3/60 694
Health Care Access and Utilization..... 13878 1 15/60 3470
Chronic Stress......................... 13878 1 4/60 925
Family Cohesion........................ 13878 1 5/60 1157
Social Support......................... 13878 1 3/60 694
Acculturation.......................... 13878 1 3/60 694
Well Being............................. 13878 1 4/60 463
Abbreviated Medication Use............. 13878 1 4/60 925
Tobacco Use............................ 13878 1 7/60 1619
Alcohol Use............................ 13878 1 3/60 694
Participant Feedback................... 13878 1 12/60 2776
---------------------------------------------------------------
Total...................................... ....................................... .............. .............. 206/60 43030
--------------------------------------------------------------------------------------------------------------------------------------------------------
Participants AFU Phone Interview (Appendix 15). AFU Year 3............................. 3146 1 15/60 787
AFU Year 4............................. 9033 1 15/60 2258
AFU Year 5............................. 14259 1 15/60 3565
AFU Year 6............................. 16222 1 15/60 4055
AFU Year 7............................. 16222 1 15/60 4055
AFU Year 8............................. 16222 1 15/60 4055
AFU Year 9............................. 16222 1 15/60 4055
AFU Year 10............................ 16222 1 15/60 4055
AFU Year 11............................ 16222 1 15/60 4055
---------------------------------------------------------------
Total...................................... ....................................... .............. .............. 120/60 30940
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: June 5, 2014.
Michael Lauer,
Director, DCVS, NHLBI, NIH.
Dated: June 5, 2014.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-14258 Filed 6-17-14; 8:45 am]
BILLING CODE 4140-01-P