Attachment 2_60 day FRN

Attachment 2_60 day FRN.pdf

Performance Evaluation Program for Rapid HIV Testing

Attachment 2_60 day FRN

OMB: 0920-0595

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28938

Federal Register / Vol. 74, No. 116 / Thursday, June 18, 2009 / Notices

DATES: Submit written comments on the
collection of information by July 20,
2009.
ADDRESSES: Submit written comments
on the collection of information by fax
202.395.6974 to the OMB Desk Officer
for AoA, Office of Information and
Regulatory Affairs, OMB.
FOR FURTHER INFORMATION CONTACT:
Yvonne Jackson; Director; Office for
American Indian, Alaskan Native and
Native Hawaiian Programs;
Administration on Aging; Washington,
DC, 20201; (202) 357–3501;
[email protected].
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, AoA
has submitted the following proposed
collection of information to OMB for
review and clearance. AoA is requesting
a continuation of an existing collection
for Annual Program Performance
Reports for Older Americans Act Title
VI grantees. Information from the Title
VI Program Performance Report
provides a data base for AoA to (1)
monitor program achievement of
performance objectives; (2) establish
program policy and direction; and (3)
prepare responses to Congress, the
OMB, the U.S. Government
Accountability Office, other federal
departments, and public and private
agencies as required by the OAA Title
II sections 202(a)19 and 208; and (4)
prepare data for the Federal Interagency
Task Force on Older Indians established
pursuant to section 134(d) of the 1987
Amendments to the OAA. If AoA did
not collect the program data herein
requested, it would not be able to
monitor and manage total program
progress as expected, nor develop
program policy options directed toward
assuring the most effective use of
limited Title VI funds. Reports are due
annually on June 30th. AoA submits an
annual report to Congress and the
reporting data is included in that report.
Estimated Number of Responses: 246.
Total Estimated Burden Hours: 615.
In the Federal Register of April 8,
2009 (Vol. 74, No. 66, Pages 15984–
15985), the agency requested comments
on the proposed collection of
information. No comments were
received.

Dated: June 12, 2009.
Edwin L. Walker,
Acting Assistant Secretary for Aging.
[FR Doc. E9–14348 Filed 6–17–09; 8:45 am]
BILLING CODE 4154–01–P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–09–0595]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
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
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects.
Alternatively, to obtain a copy of the
data collection plans and instrument,
call 404–639–5960 and send comments
to Maryam I. Daneshvar, CDC Reports
Clearance Officer, 1600 Clifton Road
NE., MS–D74, Atlanta, Georgia 30333;
comments may also be sent by e-mail to
[email protected].
Comments are invited on (a) whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarify of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of information technology. Written
comments should be received within 60
days of this notice.
Proposed Project
The Model Performance Evaluation
Program for HIV Rapid Testing (MPEP
HIV–RT) (OMB Control No. 0920–0595,
expiration date 3/31/2010)—Revision—
National Center for Preparedness,
Detection, and Control of Infectious
Diseases (NCPDCID), Centers for Disease
Control and Prevention (CDC).
Brief Description and Background
To support CDC’s mission of
improving public health and preventing
disease through continuously improving
laboratory practices, CDC is requesting
approval from the Office of Management
and Budget (OMB) to continue data
collection activities of the HIV rapid
testing performance evaluation program

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(MPEP HIV RT) and to make changes to
the results form.
This program offers external
performance evaluation (PE) twice a
year for rapid HIV tests approved by the
U.S. Food and Drug Administration
(FDA). Examples of such tests are the
OraQuick ADVANCE Rapid HIV–1⁄2
Antibody Test, the Uni-Gold
Recombigen HIV test, the Clearview HIV
1⁄2 STAT–PAK, the Clearview
COMPLETE HIV 1⁄2, and the MedMira
Reveal G3 Rapid HIV–1 Antibody Test.
Participation in PE programs is expected
to lead to improved HIV testing
performance because participants have
the opportunity to identify areas for
improvement in their testing practices.
This program helps to ensure accurate
HIV rapid testing which is the
foundation for HIV prevention and
intervention programs.
This program offers laboratories/
testing sites opportunities for:
(1) Assuring that the laboratories/
testing sites are providing accurate test
results through external quality
assessment
(2) Improving testing quality through
self-evaluation in a non-regulatory
environment
(3) Testing well characterized samples
from a source outside the test kit
manufacturer
(4) Discovering potential testing
problems so that laboratories/testing
sites can adjust procedures to reduce
and eliminate errors
(5) Comparing individual laboratory/
testing site results to others at the
national and international level, and
(6) Consulting with CDC staff to
discuss testing issues.
Program participants receive PE
samples twice each year and report
testing results to CDC. In addition to
conducting the performance evaluation,
participants in the MPEP HIV Rapid
Testing program are required to
complete a biennial (every other year)
laboratory practices questionnaire. The
burden for the Laboratory Practices
Questionnaire has been adjusted for the
average per year, since respondents
complete the survey every two years.
CDC does not charge any fees to sites
participating in this external quality
assessment program.
There is no cost to respondents to
participate in this program.

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28939

Federal Register / Vol. 74, No. 116 / Thursday, June 18, 2009 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average burden per response (in
hours)

Number
of respondents

Number of responses per
respondent

Labs .................................................................................................................
Labs .................................................................................................................

660
330

2
1

10/60
30/60

220
165

Total ..........................................................................................................

........................

........................

........................

385

Respondents

Dated: June 11, 2009.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–14312 Filed 6–17–09; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day-09–0600]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
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
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects.
Alternatively, to obtain a copy of the
data collection plans and instrument,
call 404–639–5960 and send comments
to Maryam I. Daneshvar, CDC Reports
Clearance Officer, 1600 Clifton Road,
NE., MS–D74, Atlanta, Georgia 30333;
comments may also be sent by e-mail to
[email protected].
Comments are invited on (a) whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have a
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarify of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of information technology. Written
comments should be received within 60
days of this notice.

VerDate Nov<24>2008

21:58 Jun 17, 2009

Jkt 217001

Proposed Project
Model Performance Evaluation
Program for Mycobacterium tuberculosis
and Non-tuberculous Mycobacterium
Drug Susceptibility Testing (OMB
Control No. 0920–0600, expiration date
03/31/2010)—Revision—National
Center for Preparedness, Detection, and
Control of Infectious Diseases
(NCPDCID), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
As part of the continuing effort to
support both domestic and global public
health objectives for treatment of
tuberculosis (TB), prevention of multidrug resistance, and surveillance
programs, CDC is requesting approval
from the Office of Management and
Budget to continue data collection from
participants in the Model Performance
Evaluation Program for Mycobacterium
tuberculosis and Non-tuberculous
Mycobacterium Drug Susceptibility
Testing. This request includes changes
to the Results Form and re-introduction
of the Laboratory Practices
Questionnaire.
While the overall number of cases of
TB in the U.S. has decreased, rates still
remain high among foreign-born
persons, prisoners, homeless
populations, and individuals infected
with HIV in major metropolitan areas.
The rate of TB cases detected in foreignborn persons has been reported to be
more than nine times higher than the
rate among the U.S. born population.
CDC’s goal to eliminate TB will be
virtually impossible without
considerable effort in assisting heavy
disease burden countries in the
reduction of tuberculosis. The Model
Performance Evaluation Program for
Mycobacterium tuberculosis and Nontuberculous Mycobacterium Drug
Susceptibility Testing program supports
this role by monitoring and evaluating
the level of performance and practices
among national and international

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Total burden
(in hours)

laboratories performing M. tuberculosis
susceptibility testing. Participation in
this program is one way laboratories can
ensure high-quality laboratory testing,
resulting in accurate and reliable testing
results.
By providing an evaluation program
to assess the ability of the laboratories
to test for drug resistant M. tuberculosis
and selected strains of Non-tuberculous
Mycobacteria (NTM), laboratories also
have a self-assessment tool to aid in
optimizing their skills in susceptibility
testing. The information obtained from
laboratories on susceptibility testing
practices and procedures is used to
establish variables related to good
performance, assessing training needs,
and aid with the development of
practice standards.
Participants in this program include
domestic clinical and public health
laboratories and international
laboratories. Data collection from
domestic laboratory participants occurs
twice per year. Data collection from
international laboratories is limited to
those that have public health
responsibilities for tuberculosis drug
susceptibility testing and have obtained
approval to participate by their national
tuberculosis program. The data
collected in this program will include
the susceptibility test results of primary
and secondary drugs, drug
concentrations, and test methods
performed by laboratories on a set of
performance evaluation (PE) samples.
The PE samples are sent to participants
twice a year. Participants also report
demographic data such as laboratory
type and the number of tests performed
annually. Participants report this data
every two years. The burden for the
Laboratory Practices Questionnaire has
been adjusted for the average per year,
since responses are received every other
year.
There is no cost to respondents to
participate other than their time.

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File Typeapplication/pdf
File TitleDocument
SubjectExtracted Pages
AuthorU.S. Government Printing Office
File Modified2009-06-22
File Created2009-06-18

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