Proposed Collection; 60-day Comment Request Evaluation of a Kidney Disease Education and Awareness Program in the Hispanic Community, 43214-43215 [2013-17365]
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43214
Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices
DATES)
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.
To Submit Comments and For Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Eileen Newman,
Associate Director, National Kidney
Disease Education Program, OCPL,
NIDDK, NIH, Building 31, Room 9A06,
9000 Rockville Pike, Bethesda, MD
20892, or call non-toll-free number 301–
435–8116 or Email your request,
including your address to:
Eileen.newman@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Comment 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.
Proposed Collection: Evaluation of a
Kidney Disease Education Program with
Promotores in the Hispanic Community,
0925–NEW, National Kidney Disease
Education Program, National Institute of
Diabetes and Digestive and Kidney
may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: July 15, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2013–17324 Filed 7–18–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-day Comment
Request Evaluation of a Kidney
Disease Education and Awareness
Program in the Hispanic Community
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 Kidney Disease Education
Program, the National Institute of
Diabetes and Digestive and Kidney
Diseases, 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.
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 proper performance of
the function of the agency, including
SUMMARY:
Diseases (NIDDK), National Institutes of
Health (NIH).
Need and Use of Information
Collection: NKDEP is developing a
kidney disease education program to
raise awareness among the Hispanic
community at risk for kidney disease.
Since diabetes is the most common
cause of kidney disease, the program is
being developed for inclusion in
existing diabetes programs being
conducted by ‘‘promotores de salud’’
(Spanish/English-speaking community
health workers). A pilot evaluation will
assess: (a) Overall quality of the program
from the client and promotor/a
perspective, including strengths and
weaknesses of the program and the
training, and areas for program
improvement; (b) effectiveness of the
program on the clients (the community
members being educated); and (c)
effectiveness of materials and training,
including promotores’ ability to deliver
education to the client and administer
the client pre-test/post-test surveys. The
pilot study will deliver strategic and
actionable guidance for refining the
educational and training materials for
national dissemination. Based on
outcomes from the pilot study, a
national evaluation is planned that will
use the client pre-test/post-test surveys
to assess: (a) Knowledge gains about
kidney disease, (b) awareness of NKDEP
resources and importance of kidney
health, (c) reported behavior change
outcomes and (d) reported health status.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
101 (see table below).
TABLE A.12.A—ESTIMATE ANNUALIZED BURDEN HOURS
Type of respondent
Pilot study collection:
Promotores ................................
Promotores ................................
emcdonald on DSK67QTVN1PROD with NOTICES
Client Group ...............................
Client Group (partial) .................
Total ....................................
VerDate Mar<15>2010
15:33 Jul 18, 2013
Number of
responses per
respondent
Number of
respondents
Form name
Response
burden
(hours)
Total
burden
hours
Promotores training pre-test, posttest, and qualitative in-depth interview post client session (Attachment 1 and 2).
Administer client pre-test, post-test,
and second post-tests for experimental and control groups (Attachment 3).
Client pre-test, post-test, second
post-test for experimental and
control groups (Attachment 3).
Client qualitative in-depth interview
post-client session (Attachment 4).
12
1
5/60
1
20
17
15/60
85
85
1
10/60
14
4
1
10/60
1
...........................................................
121
........................
........................
101
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43215
Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices
Dated: July 10, 2013.
Ruby N. Akomeah,
Project Clearance Liaison, NIDDK, NIH.
[FR Doc. 2013–17365 Filed 7–18–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB review; 30-day
Comment Request: The Agricultural
Health Study: A Prospective Cohort
Study of Cancer and Other Disease
Among Men and Women in Agriculture
(NCI)
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 to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on April 23, 2013, Vol. 78, page
23942 and allowed 60-days for public
comment. One public comment was
received on April 23, 2013, that
questioned spending taxpayer money
for this research. An email response was
sent on April 24, 2013, stating, ‘‘We
received your comment. We will take
your comments into consideration’’. The
purpose of this notice is to allow an
additional 30 days for public comment.
The National Cancer Institute (NCI),
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
SUMMARY:
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.
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: Jane Hoppin, Sc.D.,
Epidemiology Branch, National Institute
of Environmental Health Sciences, NIH,
111 T.W. Alexander Drive, PO Box
12233, MD A3–05, Research Triangle
Park, NC 27709, or call non-toll-free
number 919–541–7622, or email your
request, including your address to:
hoppin1@niehs.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Proposed Collection: The Agricultural
Health Study: A Prospective Cohort
Study of Cancer and Other Disease
Among Men and Women in Agriculture,
0925–0406—REVISION—National
Institute of Environmental Health
Sciences (NIEHS), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The purpose of this
information collection is to request
initiation of a new dust specimen
component as part of the ongoing Study
of Biomarkers of Exposures and Effects
in Agriculture (BEEA) as well as
continue and complete phase IV (2013–
2015) of the Agricultural Health Study
(AHS) and continue buccal cell
collection. Phase IV will continue to
update the occupational and
environmental exposure information as
well as medical history information for
licensed pesticide applicators and their
spouses enrolled in the AHS. The new
BEEA dust component will include a
brief paper-and-pen questionnaire
mailed to the participant in advance of
the home visit; at the home visit, the
study phlebotomist will to collect and
review the questionnaire, and collect
the participant’s disposable vacuum bag
(or empty the dust from vacuums
without disposable bags). The dust
component will use similar procedures
to ones that have been employed on
other NCI studies to obtain information
about the dust specimen and to collect
and ship the dust specimen. The
primary objectives of the study are to
determine the health effects resulting
from occupational and environmental
exposures in the agricultural
environment. Secondary objectives
include evaluating biological markers
that may be associated with agricultural
exposures and risk of certain types of
cancer. Phase IV questionnaire data are
collected by using self-administered
computer assisted web survey (CAWI);
self-administered paper-and-pen (Paper/
pen); or an interviewer administered
computer assisted telephone interview
(CATI) and in-person interview (CAPI)
systems for telephone screeners and
home visit interviews, respectively.
Some respondents are also asked to
participate in the collection of
biospecimens and environmental
samples, including blood, urine, buccal
cells (loose cells from the respondent’s
mouth), and vacuum dust. The findings
will provide valuable information
concerning the potential link between
agricultural exposures and cancer and
other chronic diseases among
Agricultural Health Study cohort
members, and this information may be
generalized to the entire agricultural
community.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
10,679.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
emcdonald on DSK67QTVN1PROD with NOTICES
Form name
Type of respondent
Reminder, Missing, and Damaged
Scripts for Buccal Cell.
BEEA CATI Eligibility Script ..............
Mailed Consent, Pre-Visit Show
Card, and Paper/Pen Dust Questionnaire.
BEEA Home Visit CAPI, Blood,
Urine, & Dust x 1.
BEEA Schedule Home Visit Scripts ..
BEEA Home Visit CAPI, Blood, &
Urine x 3.
Paper/pen, CAWI or CATI .................
Private and Commercial Applicators
and Spouses.
Private Applicators ...........................
Private Applicators ...........................
100
1
5/60
8
480
160
1
1
20/60
20/60
160
53
Private Applicators ...........................
160
1
90/60
240
Private Applicators ...........................
Private Applicators ...........................
20
20
3
3
5/60
30/60
5
30
Private Applicators ...........................
13,855
1
25/60
5,773
VerDate Mar<15>2010
15:33 Jul 18, 2013
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]]>Agencies
[Federal Register Volume 78, Number 139 (Friday, July 19, 2013)]
[Notices]
[Pages 43214-43215]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17365]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-day Comment Request Evaluation of a
Kidney Disease Education and Awareness Program in the Hispanic
Community
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 Kidney Disease
Education Program, the National Institute of Diabetes and Digestive and
Kidney Diseases, 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.
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
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.
To Submit Comments and For Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Eileen
Newman, Associate Director, National Kidney Disease Education Program,
OCPL, NIDDK, NIH, Building 31, Room 9A06, 9000 Rockville Pike,
Bethesda, MD 20892, or call non-toll-free number 301-435-8116 or Email
your request, including your address to: Eileen.newman@nih.gov. Formal
requests for additional plans and instruments must be requested in
writing.
Comment 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.
Proposed Collection: Evaluation of a Kidney Disease Education
Program with Promotores in the Hispanic Community, 0925-NEW, National
Kidney Disease Education Program, National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK), National Institutes of Health
(NIH).
Need and Use of Information Collection: NKDEP is developing a
kidney disease education program to raise awareness among the Hispanic
community at risk for kidney disease. Since diabetes is the most common
cause of kidney disease, the program is being developed for inclusion
in existing diabetes programs being conducted by ``promotores de
salud'' (Spanish/English-speaking community health workers). A pilot
evaluation will assess: (a) Overall quality of the program from the
client and promotor/a perspective, including strengths and weaknesses
of the program and the training, and areas for program improvement; (b)
effectiveness of the program on the clients (the community members
being educated); and (c) effectiveness of materials and training,
including promotores' ability to deliver education to the client and
administer the client pre-test/post-test surveys. The pilot study will
deliver strategic and actionable guidance for refining the educational
and training materials for national dissemination. Based on outcomes
from the pilot study, a national evaluation is planned that will use
the client pre-test/post-test surveys to assess: (a) Knowledge gains
about kidney disease, (b) awareness of NKDEP resources and importance
of kidney health, (c) reported behavior change outcomes and (d)
reported health status.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 101 (see table below).
Table A.12.A--Estimate Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Response
Type of respondent Form name Number of responses per burden Total burden
respondents respondent (hours) hours
----------------------------------------------------------------------------------------------------------------
Pilot study collection:
Promotores................ Promotores 12 1 5/60 1
training pre-
test, post-
test, and
qualitative in-
depth interview
post client
session
(Attachment 1
and 2).
Promotores................ Administer 20 17 15/60 85
client pre-
test, post-
test, and
second post-
tests for
experimental
and control
groups
(Attachment 3).
Client Group.............. Client pre-test, 85 1 10/60 14
post-test,
second post-
test for
experimental
and control
groups
(Attachment 3).
Client Group (partial).... Client 4 1 10/60 1
qualitative in-
depth interview
post-client
session
(Attachment 4).
---------------------------------------------------------------
Total................. ................ 121 .............. .............. 101
----------------------------------------------------------------------------------------------------------------
[[Page 43215]]
Dated: July 10, 2013.
Ruby N. Akomeah,
Project Clearance Liaison, NIDDK, NIH.
[FR Doc. 2013-17365 Filed 7-18-13; 8:45 am]
BILLING CODE 4140-01-P
