Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications; Availability, 56153-56154 [E6-15693]
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Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Notices
in the spread of these pathogens.
Pathogens that can cause diseases after
an infected person handles food are the
following:
Noroviruses.
Hepatitis A virus.
Salmonella Typhi.*
Shigella species.
Staphylococcus aureus.
Streptococcus pyogenes.
II. Pathogens Occasionally Transmitted
by Food Contaminated by Infected
Persons Who Handle Food, But Usually
Transmitted by Contamination at the
Source or in Food Processing or by
Non-foodborne Routes
Other pathogens are occasionally
transmitted by infected persons who
handle food, but usually cause disease
when food is intrinsically contaminated
or cross-contaminated during processing
or preparation. Bacterial pathogens in
this category often require a period of
temperature abuse to permit their
multiplication to an infectious dose
before they will cause disease in
consumers. Preventing food contact by
persons who have an acute diarrheal
illness will decrease the risk of
transmitting the following pathogens:
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Campylobacter jejuni.
Cryptosporidium parvum.
Entamoeba histolytica.
Enterohemorrhagic Escherichia coli.
Enterotoxigenic Escherichia coli.
Giardia lamblia.
Nontyphoidal Salmonella.
Sapoviruses.
Taenia solium.
Vibrio cholerae.
Yersinia enterocolitica.
VerDate Aug<31>2005
21:03 Sep 25, 2006
Jkt 208001
Dated: September 15, 2006.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention (CDC).
[FR Doc. E6–15712 Filed 9–25–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D–0044]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance for
Industry and Food and Drug
Administration Staff:
Recommendations for Clinical
Laboratory Improvement Amendments
of 1988 Waiver Applications;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
References
1. World Health Organization. Health
surveillance and management
procedures for food-handling personnel:
report of a WHO consultation. World
Health Organization technical report
series; 785. Geneva: World Health
Organization, 1989.
2. Frank JF, Barnhart HM. Food and
dairy sanitation. In: Last JM, ed. MaxcyRosenau public health and preventive
medicine, 12th edition. New York
Appleton-Century-Crofts, 1986:765–806.
3. Bennett JV, Holmberg SD, Rogers
MF, Solomon SL. Infectious and
parasitic diseases. In: Amler RW, Dull
HB, eds. Closing the gap: the burden of
unnecessary illness. New York: Oxford
University Press, 1987:102–114.
4. Centers for Disease Control and
Prevention. Locally acquired
neurocysticercosis—North Carolina,
Massachusetts, and South Carolina,
1989–1991. MMWR 1992; 41:1–4.
* Kauffmann-White scheme for designation of
Salmonella serotypes.
5. Centers for Disease Control and
Prevention. Foodborne Outbreak of
Cryptosporidiosis-Spokane,
Washington, 1997. MMWR 1998; 47:27.
6. Noel JS, Humphrey CD, Rodriguez
EM, et al., Parkville virus: A novel
genetic variant of human calicivirus in
the sapporo virus clade, associated with
an outbreak of gastroenteritis in adults.
J. Med. Virol. 52:173–178, 1997.
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 October 26,
2006.
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:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1472.
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.
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56153
Draft Guidance for Industry and Food
and Drug Administration Staff:
Recommendations for Clinical
Laboratory Improvement Amendments
(CLIA) of 1988 Waiver Applications;
Availability
Congress passed the 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 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 CLIA
standards (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
mechanism and a description of the
studies validating these mechanisms; a
description of clinical tests that
demonstrate accuracy of the test in the
hands of intended operators; and
statistical analysis of clinical study
results. The guidance also make
recommendations concerning labeling
of ‘‘waived tests.’’ The burden
associated with most of these labeling
recommendations is approved under
OMB control number 0910–0485.
Only new information collections not
already approved, are included in the
estimate in this document.
Recommendations for quick reference
instructions are written in simple
language that can be posted. The
guidance also notes that ‘‘waived tests’’
remain subject to applicable reporting
and recordkeeping requirements under
21 CFR part 803. The burden associated
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56154
Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Notices
with this provision is approved under
OMB control number 0910–0437.
Respondents to this collection of
information are manufacturers of in
vitro diagnostic devices.
In the Federal Register of September
7, 2005 (70 FR 53231), FDA solicited
comments on the collection of
information requirements. No comments
were received in response to this notice.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No of Respondents
Annual Frequency
per Response
40
Total Annual Responses
1
1There
Hours per
Response
40
Total Hours
780
31,200
Total Operating &
Maintenance
Costs
$5,500
are no capital costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of Recordkeepers
Annual Frequency
per Recordkeeper
40
1There
1
Hours per Record
40
Total Hours
2,800
112,000
Total Operating &
Maintenance
Costs
$60,700
are no capital costs associated with this collection of information.
Based on previous years of
experience, with CLIA waiver
applications, FDA expects 40
manufacturers to apply for one CLIA
waiver per year. The annual reporting
burden to respondents is estimated to be
31,200 hours and the recordkeeping
burden for respondents is estimated to
be 112,00 hours. FDA based the
reporting and recordkeeping burden on
agency analysis of premarket
submissions with clinical trials similar
to the waived laboratory tests.
The total operating and maintenance
costs associated with the
implementation of this draft guidance is
estimated to be $66,200. The cost
consists of specimen collections for the
clinical study (estimated at $23,500);
laboratory supplies, reference testing,
and study oversight (estimated at
$26,700); shipping and office supplies
(estimated at $6,000); and educational
materials, including quick reference
instructions (estimated at $10,000).
Dated: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–15693 Filed 9–25–06; 8:45 am]
BILLING CODE 4160–01–S
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Total Annual
Records
VerDate Aug<31>2005
21:03 Sep 25, 2006
Jkt 208001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0357]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Procedures for the
Safe and Sanitary Processing and
Importing of Fish and Fishery Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
extending OMB approval on the existing
reporting and recordkeeping
requirements for processors and
importers of fish and fishery products.
DATES: Submit written or electronic
comments on the collection of
information by November 27, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
PO 00000
Frm 00055
Fmt 4703
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Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60–day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
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]]>Agencies
[Federal Register Volume 71, Number 186 (Tuesday, September 26, 2006)]
[Notices]
[Pages 56153-56154]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15693]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D-0044]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance for
Industry and Food and Drug Administration Staff: Recommendations for
Clinical Laboratory Improvement Amendments of 1988 Waiver Applications;
Availability
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 October
26, 2006.
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: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1472.
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.
Draft Guidance for Industry and Food and Drug Administration Staff:
Recommendations for Clinical Laboratory Improvement Amendments (CLIA)
of 1988 Waiver Applications; Availability
Congress passed the 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
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 CLIA standards (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 mechanism and a description of the studies validating
these mechanisms; a description of clinical tests that demonstrate
accuracy of the test in the hands of intended operators; and
statistical analysis of clinical study results. The guidance also make
recommendations concerning labeling of ``waived tests.'' The burden
associated with most of these labeling recommendations is approved
under OMB control number 0910-0485.
Only new information collections not already approved, are included
in the estimate in this document. Recommendations for quick reference
instructions are written in simple language that can be posted. The
guidance also notes that ``waived tests'' remain subject to applicable
reporting and recordkeeping requirements under 21 CFR part 803. The
burden associated
[[Page 56154]]
with this provision is approved under OMB control number 0910-0437.
Respondents to this collection of information are manufacturers of
in vitro diagnostic devices.
In the Federal Register of September 7, 2005 (70 FR 53231), FDA
solicited comments on the collection of information requirements. No
comments were received in response to this notice.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No of Annual Frequency Total Annual Hours per Total Operating &
Respondents per Response Responses Response Total Hours Maintenance Costs
----------------------------------------------------------------------------------------------------------------
40 1 40 780 31,200 $5,500
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Total Operating &
No. of Recordkeepers per Recordkeeper Records Hours per Record Total Hours Maintenance Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
40 1 40 2,800 112,000 $60,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs associated with this collection of information.
Based on previous years of experience, with CLIA waiver
applications, FDA expects 40 manufacturers to apply for one CLIA waiver
per year. The annual reporting burden to respondents is estimated to be
31,200 hours and the recordkeeping burden for respondents is estimated
to be 112,00 hours. FDA based the reporting and recordkeeping burden on
agency analysis of premarket submissions with clinical trials similar
to the waived laboratory tests.
The total operating and maintenance costs associated with the
implementation of this draft guidance is estimated to be $66,200. The
cost consists of specimen collections for the clinical study (estimated
at $23,500); laboratory supplies, reference testing, and study
oversight (estimated at $26,700); shipping and office supplies
(estimated at $6,000); and educational materials, including quick
reference instructions (estimated at $10,000).
Dated: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-15693 Filed 9-25-06; 8:45 am]
BILLING CODE 4160-01-S
