Agency Information Collection Activities; Proposed Collection; Comment Request; Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications, 53750-53751 [E9-25177]
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53750
Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices
consent for research involving leftover
or unidentifiable specimens.
In a level one guidance document
issued under the Good Guidances
Practices regulation, 21 CFR 10.115,
FDA outlines the circumstances in
which it intends to exercise
enforcement discretion as to the
informed consent regulations for
clinical investigators, sponsors, and
IRBs.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN
FD&C
Act Section:
No. of
Recordkeepers
520(g)
Annual Frequency
per Recordkeeping
700
1
The recommendations of this
guidance impose a minimal burden on
industry. FDA estimates that 700 studies
will be affected annually. Each study
will result in one recordkeeping per
year, estimated to take 4 hours to
complete. This results in a total
recordkeeping burden of 2,400 hours
(700 x 4 = 2,800). FDA estimates that the
cost of developing standard operating
procedures for each record keeper is
$300 (6 hours of work at $50/hour (h)).
This results in a total cost to industry of
$210,000 ($300 x 700 recordkeepers).
FDA estimates that operating costs for
collecting this information is $300 per
record keeper (6 hours of work at $50/
h). This results in a total operational
and maintenance cost to industry of
$210,000 ($300 x 700 recordkeepers).
The total cost of this recordkeeping,
capital plus operational and
maintenance cost is estimated to be
$420,000.
Dated: October 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25178 Filed 10–19–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0489]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Recommendations
for Clinical Laboratory Improvement
Amendments of 1988 Waiver
Applications
AGENCY:
Food and Drug Administration,
cprice-sewell on DSKGBLS3C1PROD with NOTICES
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
VerDate Nov<24>2008
14:46 Oct 19, 2009
Jkt 220001
Total Annual
Records
Hours
per Record
700
Total
Hours
4
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
collections of information associated
with the guidance issued January 30,
2008, and titled ‘‘Recommendations:
Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver
Applications for Manufacturers of In
Vitro Diagnostic Devices’’.
DATES: Submit written or electronic
comments on the collection of
information by December 21, 2009.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
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:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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
PO 00000
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Fmt 4703
Sfmt 4703
2,800
Total
Capital Costs
$210,000
Total Operating and
Maintenance Costs
$420,000
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
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
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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
E:\FR\FM\20OCN1.SGM
20OCN1
Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices
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
53751
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.
FDA estimates the burden of this
collection 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)
cprice-sewell on DSKGBLS3C1PROD with NOTICES
1 There
Annual Frequency
per Recordkeeping
40
Total Annual
Records
1
Hours per
Record
40
2,800
Total Hours
112,000
Operating and
Maintenance Costs
$16,000
are no capital costs associated with this collection of information.
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
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 § 809.10 have been
approved under OMB control number
0910–0485 and the collections of
information in 21 CFR part 803 have
VerDate Nov<24>2008
14:46 Oct 19, 2009
Jkt 220001
been approved under OMB control
number 0910–0437.
Dated: October 9, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25177 Filed 10–19–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0490]
Draft Guidance for Industry and Food
and Drug Administration Staff:
Investigational New Drug Applications
for Minimally Manipulated, Unrelated
Allogeneic Placental/Umbilical Cord
Blood Intended for Hematopoietic
Reconstitution for Specified
Indications; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry and FDA Staff:
Investigational New Drug Applications
(INDs) for Minimally Manipulated,
Unrelated Allogeneic Placental/
Umbilical Cord Blood Intended for
Hematopoietic Reconstitution for
Specified Indications,’’ dated October
2009. In this draft guidance, we refer to
these products for hematopoietic
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
reconstitution for specified indications
as hematopoietic progenitor cells, cord
(HPC–C). This draft guidance provides
advice to potential sponsors (e.g.,
generally cord blood banks, or registries,
and individual physicians serving as
sponsor-investigators) to assist in the
submission of an IND for certain HPC–
Cs, when such HPC–Cs are not licensed
in accordance with certain FDA
regulations, and when a suitable human
leukocyte antigen (HLA) matched cord
blood transplant is needed for treatment
of a patient with a serious or lifethreatening disease or condition and
there is no satisfactory alternative
treatment. This draft guidance
document is applicable only to HPC–Cs
intended for hematopoietic
reconstitution in patients with the
clinical indications listed in the
guidance entitled ‘‘Guidance for
Industry: Minimally Manipulated,
Unrelated Allogeneic Placental/
Umbilical Cord Blood Intended for
Hematopoietic Reconstitution for
Specified Indications’’ (HPC–C
licensure guidance), published
elsewhere in this issue of the Federal
Register. FDA is also announcing that it
no longer intends to exercise
enforcement discretion with respect to
the IND and biologics license
application (BLA) requirements for
minimally manipulated, unrelated
allogeneic hematopoietic stem/
progenitor cell products and the phasein implementation period for IND and
license application requirements will
end as of October 20, 2011.
E:\FR\FM\20OCN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 201 (Tuesday, October 20, 2009)]
[Notices]
[Pages 53750-53751]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25177]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0489]
Agency Information Collection Activities; Proposed Collection;
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 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 collections of information
associated with the guidance issued January 30, 2008, and titled
``Recommendations: Clinical Laboratory Improvement Amendments of 1988
(CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic
Devices''.
DATES: Submit written or electronic comments on the collection of
information by December 21, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug 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: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
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 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 respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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
[[Page 53751]]
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.
FDA estimates the burden of this collection 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.
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 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 Sec. 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.
Dated: October 9, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25177 Filed 10-19-09; 8:45 am]
BILLING CODE 4160-01-S
