Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications, 6206-6207 [2010-2598]
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6206
Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of
respondent
Form name
Parent ................
Parent ................
Parent ................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Child ..................
Teacher .............
Social Isolation/Support ...............................................................................
Strengths and Difficulties Questionnaire (SDQ) ..........................................
Vanderbilt Parent Rating Scale ...................................................................
Brief Sensation Seeking Scale ....................................................................
Conflict in Adolescent Dating Relationships ................................................
Health Risk Behavior Survey (Middle School) 11–13 years .......................
Health Risk Behavior Survey (High School) 14+ years ..............................
MARSH—Self Description Questionnaire v I, 7–12 years ..........................
MARSH—Self Description Questionnaire v II, 13–15 years .......................
MARSH—Self Description Questionnaire v III 16+ years ...........................
Social Inventory (High School) 14+ years ...................................................
Olweus Bullying Questionnaire (High School) 14+ years ...........................
Pediatric Quality of Life Child (8–12) ...........................................................
Pediatric Quality of Life Teen (13+) .............................................................
Youth Demographic Survey, 16+ years .......................................................
Teacher Survey ............................................................................................
Dated: February 1, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–2600 Filed 2–5–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0489]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recommendations
for Clinical Laboratory Improvement
Amendments of 1988 Waiver
Applications
AGENCY:
Food and Drug Administration,
HHS.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 10,
2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0598. Also
VerDate Nov<24>2008
11:51 Feb 05, 2010
Jkt 220001
Number of
respondents
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Recommendations for Clinical
Laboratory Improvement Amendments
of 1988 Waiver Applications—21 CFR
Section 493 (OMB Control Number
0910–0598)—Extension
Congress passed the Clinical
Laboratory Improvements Amendment
(CLIA) (Public Law 100–578) in 1988 to
establish quality standards for all
laboratory testing. The purpose was to
ensure the accuracy, reliability, and
timeliness of patient test results
regardless of where the test took place.
CLIA requires that clinical laboratories
obtain a certificate from the Secretary of
Health and Human Services (the
Secretary), before accepting materials
derived from the human body for
laboratory tests (42 U.S.C. 263a(b)).
Laboratories that perform only tests that
are ‘‘simple’’ and that have an
‘‘insignificant risk of an erroneous
result’’ may obtain a certificate of waiver
(42 U.S.C. 263a(c)(2)). The Secretary has
delegated to FDA the authority to
determine whether particular tests
(waived tests) are ‘‘simple’’ and have ‘‘an
insignificant risk of an erroneous result’’
under CLIA (69 FR 22849, April 27,
2004). This guidance document
describes recommendations for device
PO 00000
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178
190
190
190
153
37
153
15
90
85
153
153
15
175
85
949
Responses
per
respondent
Avg. burden
per response
(in hours)
1
2
2
1
1
1
1
1
1
1
1
1
1
1
1
1
2/60
3/60
10/60
1/60
10/60
15/60
25/60
5/60
7/60
9/60
10/60
7/60
5/60
5/60
5/60
10/60
manufacturers submitting to FDA an
application for determination that a
cleared or approved device meets this
CLIA standard (CLIA waiver
application). The guidance recommends
that CLIA waiver applications include a
description of the features of the device
that make it ‘‘simple’’; a report
describing a hazard analysis that
identifies potential sources of error,
including a summary of the design and
results of flex studies and conclusions
drawn from the flex studies; a
description of fail-safe and failure alert
mechanisms and a description of the
studies validating these mechanisms; a
description of clinical tests that
demonstrate the accuracy of the test in
the hands of intended operators; and
statistical analyses of clinical study
results. Only new information
collections not already approved are
included in the estimate in the
following table. Quick reference
instructions are a short version of the
instructions that are written in simple
language and that can be posted.
The total number of reporting and
recordkeeping hours is 143,200 hours.
FDA bases the burden on an agency
analysis of premarket submissions with
clinical trials similar to the waived
laboratory tests. Based on previous
years’ experience with CLIA waiver
applications, FDA expects 40
manufacturers to submit one CLIA
waiver application per year. The time
required to prepare and submit a waiver
application, including the time needed
to assemble supporting data, averages
780 hours per waiver application for a
total of 31,200 hours for reporting.
Based on previous years experience
with CLIA waiver applications, FDA
expects that each manufacturer will
spend 2,800 hours creating and
E:\FR\FM\08FEN1.SGM
08FEN1
Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices
maintaining the record for a total of
112,000 hours. The total operating and
maintenance cost associated with the
waiver application is estimated at
$66,200. The cost consists of specimen
collection for the clinical study
(estimated $23,500); laboratory supplies,
reference testing and study oversight
(estimated $26,700); shipping and office
supplies (estimated $6,000); and
educational materials, including quick
reference instructions (estimated
$10,000). This guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR part 801 and 21 CFR 809.10 have
been approved under OMB control
number 0910–0485 and the collections
of information in 21 CFR part 803 have
6207
been approved under OMB control
number 0910–0437.
In the Federal Register of October 20,
2009 (74 FR 53750), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
493.15(a) and (b)
1 There
Annual Frequency
of Response
40
Total Annual
Responses
1
Hours per
Response
40
Total Hours
780
31,200
Operating and
Maintenance Costs
$50,200
are no capital costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
493.15(a) and (b)
1 There
Annual Frequency
per Recordkeeping
40
1
Hours per
Record
40
Total Hours
2,800
112,000
Operating and
Maintenance Costs
$16,000
are no capital costs associated with this collection of information.
Dated: January 25, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–2598 Filed 2–5–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Lost People Finder System
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 Library of Medicine (NLM), 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.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Total Annual
Records
Proposed Collection
Title: Lost People Finder System;
Type of Information Collection Request:
Extension of currently approved
collection [OMB No. 0925–0612,
expiration date 07/31/2010], Form
Number: NA; Need and Use of
Information Collection: The National
Library of Medicine (NLM) proposes the
continuation of a voluntary collection of
data to assist in the reunification of
family members and loved ones who are
separated during a disaster.
Reunification is important to both the
VerDate Nov<24>2008
11:51 Feb 05, 2010
Jkt 220001
emotional well-being of people injured
during a disaster and to their medical
care. Family members often provide
important health information to care
providers who are treating the injured
(e.g., providing medical history or
information about allergies) and they
may provide longer-term care for those
released from emergency care. NLM
proposes this data collection as part of
its mission to develop and coordinate
communication technologies to improve
the delivery of health services. The data
collection is authorized pursuant to
sections 301, 307, 465 and 478A of the
Public Health Service Act [42 U.S.C.
241, 242l, 286 and 286d]. NLM is a
member of the Bethesda Hospitals’
Emergency Preparedness Partnership
(BHEPP), which was established in 2004
to improve community disaster
preparedness and response among
hospitals in Bethesda, Maryland that
would likely be called upon to absorb
mass casualties in a major disaster in
the National Capital Region. BHEPP
hospitals include the National Naval
Medical Center (NNMC), the National
Institutes of Health Clinical Center (NIH
CC), and Suburban Hospital/Johns
Hopkins Medicine. NLM, with its
expertise in communications,
information management, and medical
informatics joined BHEPP to coordinate
the R&D program, one element of which
is development of a lost person finder
to assist in family reunification after a
disaster. NLM’s Lost People Finder
System would collect information, on a
voluntary basis, about people who are
missing and who are found (recovered)
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
during a disaster. Information on
recovered individuals would be
gathered voluntarily from medical and
relief personnel who either use a
specialized application developed by
NLM for the iPhone or submit
information to NLM by e-mail via
computer or cell phone. The iPhone
application enables submission of
photographs and descriptive
information about recovered victims in
a structured format, e.g., name (if
available), age category, gender, general
status (healthy, injured), location.
Information about missing persons
would be submitted by members of the
public who are seeking family members,
friends, and other loved ones. An
interactive Web-based system offers the
public a tool for searching for people
who have been found (e.g., recovered by
medical staff and other relief workers)
and for voluntarily posting information
about people who are still missing. In
addition, the system would collect
information on a regular basis from
other publicly available systems for that
are used for reunification during a
disaster for information (e.g., the Google
Person Finder system that was deployed
during the 2010 earthquakes in Haiti). In
addition, information submitted directly
to NLM’s Lost People Finder System
would be transferred to other systems
that are endorsed by U.S. government
agencies to ensure that users of such
systems can search the complete set of
available information for their family
members and loved ones and to ensure
that use of the NLM system in no way
interrupts or distracts from the
E:\FR\FM\08FEN1.SGM
08FEN1
]]>Agencies
[Federal Register Volume 75, Number 25 (Monday, February 8, 2010)]
[Notices]
[Pages 6206-6207]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-2598]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0489]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Recommendations for
Clinical Laboratory Improvement Amendments of 1988 Waiver Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by March
10, 2010.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0598.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Recommendations for Clinical Laboratory Improvement Amendments of 1988
Waiver Applications--21 CFR Section 493 (OMB Control Number 0910-
0598)--Extension
Congress passed the Clinical Laboratory Improvements Amendment
(CLIA) (Public Law 100-578) in 1988 to establish quality standards for
all laboratory testing. The purpose was to ensure the accuracy,
reliability, and timeliness of patient test results regardless of where
the test took place. CLIA requires that clinical laboratories obtain a
certificate from the Secretary of Health and Human Services (the
Secretary), before accepting materials derived from the human body for
laboratory tests (42 U.S.C. 263a(b)). Laboratories that perform only
tests that are ``simple'' and that have an ``insignificant risk of an
erroneous result'' may obtain a certificate of waiver (42 U.S.C.
263a(c)(2)). The Secretary has delegated to FDA the authority to
determine whether particular tests (waived tests) are ``simple'' and
have ``an insignificant risk of an erroneous result'' under CLIA (69 FR
22849, April 27, 2004). This guidance document describes
recommendations for device manufacturers submitting to FDA an
application for determination that a cleared or approved device meets
this CLIA standard (CLIA waiver application). The guidance recommends
that CLIA waiver applications include a description of the features of
the device that make it ``simple''; a report describing a hazard
analysis that identifies potential sources of error, including a
summary of the design and results of flex studies and conclusions drawn
from the flex studies; a description of fail-safe and failure alert
mechanisms and a description of the studies validating these
mechanisms; a description of clinical tests that demonstrate the
accuracy of the test in the hands of intended operators; and
statistical analyses of clinical study results. Only new information
collections not already approved are included in the estimate in the
following table. Quick reference instructions are a short version of
the instructions that are written in simple language and that can be
posted.
The total number of reporting and recordkeeping hours is 143,200
hours. FDA bases the burden on an agency analysis of premarket
submissions with clinical trials similar to the waived laboratory
tests. Based on previous years' experience with CLIA waiver
applications, FDA expects 40 manufacturers to submit one CLIA waiver
application per year. The time required to prepare and submit a waiver
application, including the time needed to assemble supporting data,
averages 780 hours per waiver application for a total of 31,200 hours
for reporting. Based on previous years experience with CLIA waiver
applications, FDA expects that each manufacturer will spend 2,800 hours
creating and
[[Page 6207]]
maintaining the record for a total of 112,000 hours. The total
operating and maintenance cost associated with the waiver application
is estimated at $66,200. The cost consists of specimen collection for
the clinical study (estimated $23,500); laboratory supplies, reference
testing and study oversight (estimated $26,700); shipping and office
supplies (estimated $6,000); and educational materials, including quick
reference instructions (estimated $10,000). This guidance also refers
to previously approved collections of information found in FDA
regulations. The collections of information in 21 CFR part 801 and 21
CFR 809.10 have been approved under OMB control number 0910-0485 and
the collections of information in 21 CFR part 803 have been approved
under OMB control number 0910-0437.
In the Federal Register of October 20, 2009 (74 FR 53750), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual Hours per Operating and
21 CFR Section Respondents Response Responses Response Total Hours Maintenance Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
493.15(a) and (b) 40 1 40 780 31,200 $50,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per Operating and
21 CFR Section Recordkeepers per Recordkeeping Records Record Total Hours Maintenance Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
493.15(a) and (b) 40 1 40 2,800 112,000 $16,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Dated: January 25, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-2598 Filed 2-5-10; 8:45 am]
BILLING CODE 4160-01-S
