Submission for OMB Review; Comment Request; Survey of Estimated Glomerular Filtration Rate Reporting Practices of Clinical Laboratories, 41029-41030 [E6-11380]
Download as PDF
<![CDATA[
41029
Federal Register / Vol. 71, No. 138 / Wednesday, July 19, 2006 / Notices
Responses
per
respondent
Number of
respondents
Reporting requirement
Audit Report .........................................................................
Entity Response ...................................................................
1
0
Total
responses
Hours per
response
Total burden
hours
1
0
1
0
1
0
1
0
Dispute Resolution
Mediation Request ...............................................................
Rebuttal ................................................................................
2
2
4
1
8
2
10
16
80
32
Total Reporting .............................................................
8
........................
14
........................
129
Recordkeeping Requirement
Dispute Records ..................................................................
10
1
10
.5
5
Total Recordkeeping .....................................................
10
........................
........................
........................
5
*Prepared by the manufacturer.
Send comments to Susan G. Queen,
Ph.D., HRSA Reports Clearance Officer,
Room 10–33, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
Written comments should be received
within 60 days of this notice.
Dated: July 12, 2006.
Cheryl R. Dammons,
Director, Division of Policy Review and
Coordination.
[FR Doc. E6–11440 Filed 7–18–06; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Survey of
Estimated Glomerular Filtration Rate
Reporting Practices of Clinical
Laboratories
SUMMARY: Under the provisions of
section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK) of 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
January 25, 2006, page 4151–4152 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.
This 30-day submission is modified in
order to reflect an increase in sample
size. 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 Survey of Estimated GFR
Reporting Practices of Clinical
Laboratories.
Type of Information Collection
Request: New.
Need and Use of Information
Collection: This study will assess the
level of U.S. clinical laboratory
reporting of estimated GFR as a measure
of kidney function through a baseline
survey of a representative sample of
clinical laboratories in the U.S. Results
will later serve as comparison to
measure an anticipated increase in use
of estimated GFR, following
implementation of the National Kidney
Disease Education Program’s
communications and Lab Working
Group (LWG) activities promoting use of
estimated GFR for patients at risk for
kidney disease. The LWG, whose
members are experts in their field,
sroberts on PROD1PC70 with NOTICES
Note: Completing this survey is similar to
other data reporting carried out by lab
directors. Since lab directors will be able to
respond to the survey within their usual
workday, this collection of information will
not cost labs/employers additional time and
money.
There are no Capital Costs to report. There
are no Operating or Maintenance Costs to
report.
Estimated
number of
responses per
respondent
Estimated
number of
respondents
Type of respondents
strongly believes that routine reporting
of estimated GFR will result in a
significant increase in early detection of
chronic kidney disease, therefore
enabling treatment that can slow or
prevent patients’ progression to kidney
failure.
Frequency of Response: Baseline
survey only.
Affected Public: Clinical laboratory
community.
Type of Respondents: Laboratory
directors.
The annual reporting burden is as
follows:
Estimated Number of Respondents:
Anticipate 5,085 completed surveys;
Estimated Number of Responses per
Respondent: Respondents will complete
one paper-and-pencil or Web-based
survey;
Average Burden Hours Per Response:
.083 hours [5 minutes]; and
Estimated Total Annual Burden
Hours Requested: 422.06 hours. The
annualized total cost to respondents is
estimated at $14,408.96.
Average
burden hours
per response
Annual total
burden hours
requested
Clinical Laboratory Directors ...........................................................
5,085
1.0
.083
422.06
Total ..........................................................................................
5,085
1.0
.083
422.06
VerDate Aug<31>2005
18:28 Jul 18, 2006
Jkt 208001
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
E:\FR\FM\19JYN1.SGM
19JYN1
41030
Federal Register / Vol. 71, No. 138 / Wednesday, July 19, 2006 / Notices
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.
FOR FURTHER INFORMATION CONTACT:
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, New
Executive Office Building, Room 10235,
Washington, DC 20503, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Elisa
Gladstone, MPH, Project Officer,
Associate Director, National Kidney
Disease Education Program, National
Institute of Diabetes and Digestive and
Kidney Diseases, National Institutes of
Health, Building 31, Center Dr., Room
9A06, Bethesda, MD 20892, or call nontoll free number 301–435–8116 or email your request, including your
address, to gladstonee@niddk.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.
sroberts on PROD1PC70 with NOTICES
Dated: July 7, 2006.
Elisa H. Gladstone,
Project Officer, Associate Director, National
Kidney Disease Education Program, National
Institute of Diabetes and Digestive and Kidney
Diseases, National Institutes of Health.
[FR Doc. E6–11380 Filed 7–18–06; 8:45 am]
BILLING CODE 4140–01–P
VerDate Aug<31>2005
18:28 Jul 18, 2006
Jkt 208001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Collection of
Demographic and Smoking/Tobacco
Use Information from NCI Cancer
Information Service Clients
SUMMARY: Under the provisions of
section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute, the National Institutes
of Health has submitted to the Office of
Management and Budget (OMB) a
request to review and approve the
information collection below. This
proposed information collection was
previously published in the Federal
Register on Friday, January 20, 2006,
page 3313 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 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: Collection
of Demographic and Smoking/Tobacco
Use Information from NCI Cancer
Information Service Clients.
Type of Information Collection
Request: Revision.
Need and Use of Information
Collection: The NCI’s Cancer
Information Service (CIS) provides
accurate and up-to-date cancer
information to the public through a tollfree telephone number (1–800–4–
CANCER) and LiveHelp, an online
instant messaging service. In addition,
CIS provides smoking cessation
assistance through a telephone quitline
(accessed through 1–800–44U–QUIT or
1–800–QUITNOW). Eligible smoking
cessation clients have the opportunity to
participate in a callback service, which
provides up to four follow-up
counseling calls. Characterizing CIS
clients is essential to customer service,
program planning, and promotion.
Currently CIS conducts a brief survey of
a sample of telephone and LiveHelp
clients at the end of usual service (OMB
No. 0925–0208); the survey includes
three customer service and five
demographic questions (age, sex, race,
ethnicity, education). This request is to
supplement the current data collection
activity by adding: (1) Four
demographic questions related to
income, health insurance coverage, and
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
regular source of health care; (2) 20
smoking intake questions for
individuals seeking smoking cessation
assistance; and (3) one smoking followup question for smoking cessation
clients participating in the callback
service. The demographic questions will
allow CIS to better measure the
program’s reach to underserved
populations and program impacts on
these populations. The smoking intake
questions are necessary as part of the
needs assessment process for smoking
cessation clients. Information about
clients smoking history, previous quit
attempts, and motivations to quit
smoking will enable Information
Specialists to provide effective
individualized counseling. The smoking
follow-up question will allow CIS to
track clients smoking behavior and
measure quit rates over the period of the
callback service. Consistent with the
current data collection, the proposed
questions will be asked of clients who
are cancer patients, family members and
friends of patients, and the general
public. The proposed sampling is
consistent with the current data
collection, with 25% of telephone and
quitline clients sampled for the
proposed demographic questions. If the
call is the result of a special promotion,
50% of callers will be surveyed. Overall,
it is estimated that 36% of telephone
and quitline clients will be sampled for
the demographic questions. The
demographic questions will be asked of
50% of LiveHelp clients; the higher
sampling rate is necessary due to the
lower response rate among online
clients. The proposed smoking intake
questions will be asked of 100% of
smoking cessation clients and the
smoking follow-up question will be
asked of 100% of smoking cessation
clients participating in the callback
service. Table 1 presents the estimated
numbers of respondents, numbers of
responses per respondent, average
burden hours per response, and annual
burden hours for each subgroup of
respondents. The combined total to be
surveyed each year is approximately
49,400 CIS clients for a total of 1,578
annual burden hours.
Frequency of Response: Single time
for demographic and smoking intake
questions; up to four times for the
smoking follow-up question.
Affected Public: Individuals or
households.
Type of Respondents: Cancer patients,
family members and friends of cancer
patients, and general public who contact
CIS via telephone or online. The annual
reporting burden is presented in Table
1.
E:\FR\FM\19JYN1.SGM
19JYN1
]]>Agencies
[Federal Register Volume 71, Number 138 (Wednesday, July 19, 2006)]
[Notices]
[Pages 41029-41030]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11380]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Survey of Estimated
Glomerular Filtration Rate Reporting Practices of Clinical Laboratories
SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK) of 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 January 25, 2006, page 4151-4152 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.
This 30-day submission is modified in order to reflect an increase in
sample size. 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 Survey of Estimated GFR Reporting Practices of Clinical
Laboratories.
Type of Information Collection Request: New.
Need and Use of Information Collection: This study will assess the
level of U.S. clinical laboratory reporting of estimated GFR as a
measure of kidney function through a baseline survey of a
representative sample of clinical laboratories in the U.S. Results will
later serve as comparison to measure an anticipated increase in use of
estimated GFR, following implementation of the National Kidney Disease
Education Program's communications and Lab Working Group (LWG)
activities promoting use of estimated GFR for patients at risk for
kidney disease. The LWG, whose members are experts in their field,
strongly believes that routine reporting of estimated GFR will result
in a significant increase in early detection of chronic kidney disease,
therefore enabling treatment that can slow or prevent patients'
progression to kidney failure.
Frequency of Response: Baseline survey only.
Affected Public: Clinical laboratory community.
Type of Respondents: Laboratory directors.
The annual reporting burden is as follows:
Estimated Number of Respondents: Anticipate 5,085 completed
surveys;
Estimated Number of Responses per Respondent: Respondents will
complete one paper-and-pencil or Web-based survey;
Average Burden Hours Per Response: .083 hours [5 minutes]; and
Estimated Total Annual Burden Hours Requested: 422.06 hours. The
annualized total cost to respondents is estimated at $14,408.96.
Note: Completing this survey is similar to other data reporting
carried out by lab directors. Since lab directors will be able to
respond to the survey within their usual workday, this collection of
information will not cost labs/employers additional time and money.
There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report.
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated number of Average burden Annual total
Type of respondents number of responses per hours per burden hours
respondents respondent response requested
----------------------------------------------------------------------------------------------------------------
Clinical Laboratory Directors........... 5,085 1.0 .083 422.06
-----------------------------------------------------------------------
Total............................... 5,085 1.0 .083 422.06
----------------------------------------------------------------------------------------------------------------
[[Page 41030]]
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.
FOR FURTHER INFORMATION CONTACT: 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, New Executive Office Building, Room 10235, Washington, DC
20503, Attention: Desk Officer for NIH. To request more information on
the proposed project or to obtain a copy of the data collection plans
and instruments, contact Elisa Gladstone, MPH, Project Officer,
Associate Director, National Kidney Disease Education Program, National
Institute of Diabetes and Digestive and Kidney Diseases, National
Institutes of Health, Building 31, Center Dr., Room 9A06, Bethesda, MD
20892, or call non-toll free number 301-435-8116 or e-mail your
request, including your address, to gladstonee@niddk.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: July 7, 2006.
Elisa H. Gladstone,
Project Officer, Associate Director, National Kidney Disease Education
Program, National Institute of Diabetes and Digestive and Kidney
Diseases, National Institutes of Health.
[FR Doc. E6-11380 Filed 7-18-06; 8:45 am]
BILLING CODE 4140-01-P
