Agency Forms Undergoing Paperwork Reduction Act Review, 76736-76737 [2011-31561]
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76736
Federal Register / Vol. 76, No. 236 / Thursday, December 8, 2011 / Notices
Number of
respondents
Type of respondent
Form name
Physician .......................
Standard Form 3881, for reimbursement for
medically necessary treatment, monitoring,
initial health evaluations.
Dated: December 2, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–31562 Filed 12–7–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30–Day–12–11GU]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Survey of Rapid Influenza Diagnostic
Test (RIDT) Practices in LaboratoriesNEW—the Office of Surveillance,
Epidemiology, and Laboratory Services
(OSELS), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Survey of Rapid Influenza
Diagnostic Testing Practices in
Laboratories is a national systematic
study investigating rapid influenza
Number
responses per
respondent
200
diagnostic testing practices in clinical
laboratories. The survey will be funded
in full by the Office of Surveillance,
Epidemiology, and Laboratory Services
(OSELS) of the Centers for Disease
Control and Prevention (CDC).
Influenza epidemics usually cause an
average of more than 200,000
hospitalizations and 36,000 deaths per
year in the U.S. Respiratory illnesses
caused by influenza viruses are not
easily differentiated from other
respiratory infections based solely on
symptoms. Also influenza viruses may
adversely affect different
subpopulations. The effective use of
rapid influenza diagnostic testing
practices is an important component of
the differential diagnosis of influenzalike-illness in both inpatient and
outpatient treatment facilities. Test
results are used for making decisions
about antiviral vs. antibiotic use, and in
making admission or discharge
decisions. In many cases, rapid
influenza tests are the only tests that can
provide results while the patient is still
present in the facility. Thus, the
appropriate use of the tests, and
interpretation of test results is critical to
the treatment and control of influenza.
More than a dozen rapid tests have been
approved by the U.S. Food and Drug
Administration and are in widespread
use. The reliability of rapid influenza
tests is influenced by the individual test
product used and the setting. Reported
sensitivities range from 10–75%; while
the median specificities reported are
90–95%. Other factors influencing
accuracy are the stage (or duration) of
illness when the diagnostic specimen is
collected, type and adequacy of the
specimen collected, variability in user
technique for specimen collection or
assay performance, and disease activity
in the community. Given these and
1
Average
burden per
response (in
hours)
Total burden
hours
15/60
50
other collective findings, it is imperative
for public health and for response
planning that CDC develops sectorspecific guidance and effective outreach
to the clinicians on appropriate use of
RIDT in their practices.
Previous studies by CDC of outpatient
facilities showed that clinical
laboratories usually perform the rapid
tests for emergency departments, and
provide results for both inpatient and
outpatient treatment. Thus,
understanding the use of rapid
influenza testing in clinical laboratories,
how the laboratories report results to
emergency departments and treatment
facilities and health departments, and
what quality assurance practices are
used will guide future efforts of the CDC
to develop appropriate influenza testing
guidelines and sector-specific training
materials for clinicians and improve
health outcomes of the American
public.
The survey covers basic laboratory
demographic characteristics, specimen
collection and processing, testing
practices, reporting of results to
emergency departments and other
treatment facilities, reporting results to
health departments, quality assurance
practices, and methods of receiving
updated influenza-related information.
The majority of the questions request
information about laboratory influenza
testing practices.
To date, no systematic study has been
conducted to investigate how
laboratories use these tests, how they
report results, or how they interact with
outpatient treatment facilities. The
survey will be conducted on a national
sample of clinical laboratories. There
are no costs to respondents except their
time. The total estimated annual burden
hours are 1020.
mstockstill on DSK4VPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Clinical Laboratory Supervisors ......................
Survey of Rapid Influenza Diagnostic Test
Practices in Laboratories.
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2040
08DEN1
Number of
responses per
respondent
1
Avg. burden
per response
(in hrs)
30/60
76737
Federal Register / Vol. 76, No. 236 / Thursday, December 8, 2011 / Notices
Dated: December 1, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–31561 Filed 12–7–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
[Document Identifier CMS–10417]
Emergency Clearance: Public
Information Collection Requirements
Submitted to the Office of Management
and Budget (OMB)
Center for Medicare and
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
mstockstill on DSK4VPTVN1PROD with NOTICES
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare and Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
We are, however, requesting an
emergency review of the information
collection referenced below. In
compliance with the requirement of
section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, we have
submitted to the Office of Management
and Budget (OMB) the following
requirements for emergency review. We
are requesting an emergency review to
ensure compliance with section
1862(a)(1)(A) of the Social Security Act.
We cannot reasonably comply with the
normal clearance procedures in that
public harm is reasonably likely to
result if normal clearance procedures
are followed as stated in 5 CFR
1320.13(a)(2)(i).
1. Type of Information Collection
Request: New collection; Title of
Information Collection: Medicare Feefor-Service Prepayment Medical
Review; Use: The information required
under this collection is requested by
Medicare contractors to determine
proper payment or if there is a suspicion
of fraud. Medicare contractors request
the information from providers or
suppliers submitting claims for payment
from the Medicare program when data
analysis indicates aberrant billing
patterns or other information which
may present a vulnerability to the
Medicare program; Form Number:
CMS–10417 (OMB 0938–New);
Frequency: Occasionally; Affected
Public: Private Sector (Business or other
for-profit and Not-for-profit
institutions); Number of Respondents:
2,700,000; Total Annual Responses:
2,700,000; Total Annual Hours:
1,360,000. (For policy questions
regarding this collection contact Debbie
Skinner at (410) 786–7480. For all other
issues call (410) 786–1326.)
CMS is requesting OMB review and
approval of this collection by December
19, 2011, with a 180-day approval
period. Written comments and
recommendations will be considered
from the public if received by December
15, 2011.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at https://www.cms.gov/
PaperworkReductionActof1995/PRAL/
list.asp or Email your request, including
your address, phone number, OMB
number, and CMS document identifier,
to Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
Interested persons are invited to send
comments regarding the burden or any
other aspect of these collections of
information requirements. However, as
noted above, comments on these
information collection and
recordkeeping requirements must be
received via one of the following
methods by December 15, 2011.
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier CMS–
10417, Room C4–26–05, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850.
3. By Email to OMB.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS
Desk Officer, Email:
OIRA_submission@omb.eop.gov.
Dated: December 2, 2011.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2011–31536 Filed 12–5–11; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration of Children and
Families
Proposed Information Collection
Activities; Comment Request
Proposed Projects
Title: 45 CFR 1301 Head Start Grant
Administration.
OMB No. 0980–0243.
Description: The Office of Head Start
is proposing to renew without changes
authority to collect information
pursuant to 45 CFR 1301. These
provisions are applicable to program
administration and grants
administration under the Head Start
Act, as amended. The provisions specify
the requirements for grantee agencies for
insurance and bonding, the submission
of audits, matching of federal funds,
accounting systems certifications and
other provisions applicable to personnel
management.
Respondents: Head Start and Early
Head Start program grant recipients.
ANNUAL BURDEN ESTIMATES
Instruments
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
45 CFR 1301 ...................................................................................................
2700
1
2
5400
VerDate Mar<15>2010
15:59 Dec 07, 2011
Jkt 226001
PO 00000
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Fmt 4703
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08DEN1
]]>Agencies
[Federal Register Volume 76, Number 236 (Thursday, December 8, 2011)]
[Notices]
[Pages 76736-76737]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31561]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-12-11GU]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an email to
omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC 20503 or by fax to (202) 395-
5806. Written comments should be received within 30 days of this
notice.
Proposed Project
Survey of Rapid Influenza Diagnostic Test (RIDT) Practices in
Laboratories-NEW--the Office of Surveillance, Epidemiology, and
Laboratory Services (OSELS), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
The Survey of Rapid Influenza Diagnostic Testing Practices in
Laboratories is a national systematic study investigating rapid
influenza diagnostic testing practices in clinical laboratories. The
survey will be funded in full by the Office of Surveillance,
Epidemiology, and Laboratory Services (OSELS) of the Centers for
Disease Control and Prevention (CDC).
Influenza epidemics usually cause an average of more than 200,000
hospitalizations and 36,000 deaths per year in the U.S. Respiratory
illnesses caused by influenza viruses are not easily differentiated
from other respiratory infections based solely on symptoms. Also
influenza viruses may adversely affect different subpopulations. The
effective use of rapid influenza diagnostic testing practices is an
important component of the differential diagnosis of influenza-like-
illness in both inpatient and outpatient treatment facilities. Test
results are used for making decisions about antiviral vs. antibiotic
use, and in making admission or discharge decisions. In many cases,
rapid influenza tests are the only tests that can provide results while
the patient is still present in the facility. Thus, the appropriate use
of the tests, and interpretation of test results is critical to the
treatment and control of influenza. More than a dozen rapid tests have
been approved by the U.S. Food and Drug Administration and are in
widespread use. The reliability of rapid influenza tests is influenced
by the individual test product used and the setting. Reported
sensitivities range from 10-75%; while the median specificities
reported are 90-95%. Other factors influencing accuracy are the stage
(or duration) of illness when the diagnostic specimen is collected,
type and adequacy of the specimen collected, variability in user
technique for specimen collection or assay performance, and disease
activity in the community. Given these and other collective findings,
it is imperative for public health and for response planning that CDC
develops sector-specific guidance and effective outreach to the
clinicians on appropriate use of RIDT in their practices.
Previous studies by CDC of outpatient facilities showed that
clinical laboratories usually perform the rapid tests for emergency
departments, and provide results for both inpatient and outpatient
treatment. Thus, understanding the use of rapid influenza testing in
clinical laboratories, how the laboratories report results to emergency
departments and treatment facilities and health departments, and what
quality assurance practices are used will guide future efforts of the
CDC to develop appropriate influenza testing guidelines and sector-
specific training materials for clinicians and improve health outcomes
of the American public.
The survey covers basic laboratory demographic characteristics,
specimen collection and processing, testing practices, reporting of
results to emergency departments and other treatment facilities,
reporting results to health departments, quality assurance practices,
and methods of receiving updated influenza-related information. The
majority of the questions request information about laboratory
influenza testing practices.
To date, no systematic study has been conducted to investigate how
laboratories use these tests, how they report results, or how they
interact with outpatient treatment facilities. The survey will be
conducted on a national sample of clinical laboratories. There are no
costs to respondents except their time. The total estimated annual
burden hours are 1020.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hrs)
----------------------------------------------------------------------------------------------------------------
Clinical Laboratory Supervisors....... Survey of Rapid 2040 1 30/60
Influenza Diagnostic
Test Practices in
Laboratories.
----------------------------------------------------------------------------------------------------------------
[[Page 76737]]
Dated: December 1, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-31561 Filed 12-7-11; 8:45 am]
BILLING CODE 4163-18-P
