Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications; Availability, 53231-53233 [05-17732]

Download as PDF Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices FDA carefully considers the benefits such agreements will provide to the public. The cooperative agreement ensures FDA’s continued participation and support in the Annual Environmental Design Contest. Through a mix of science and engineering, it creates new resources and stimulates new and timely solutions to real world environmental problems. II. Eligibility Information Competition is limited to WERC because it is a unique educational opportunity and is the only college level competition of its kind. WERC, a Consortium for Environmental Education and Technology Development, a program of the College of Engineering at New Mexico State University, was established in 1990 under a cooperative agreement with the U.S. Department of Energy. Starting in 1991, WERC has conducted an Annual Environmental Design Contest which is a unique educational experience for students from throughout the world. The contest provides an opportunity for students to address real world environmental and food safety related problems, experience a team developed project, publish research papers, and network with experts and potential employers. The contest is open to any 2-year, 4-year, or graduate degree institution. A high school-level competition has been held concurrently with the university contest since 1997. Many of the tasks deal with waste disposal, ground water contamination, nuclear waste treatment, and similar subjects; however in 2001, a food safety track was added and the contest was broadened to include disciplines such as microbiology and chemical contaminants in foods. The FDA has supported this program since Fiscal Year 2000. This notice confirms FDA’s intent to fund for another 5-year project period. As of October 1, 2003, applicants are required to have a Dun and Bradstreet Number (DUNS) to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a 9digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, call 1–866–705–5711. You should identify yourself as a Federal grant applicant when you contact Dun and Bradstreet, Inc. III. Application and Submission For further information or a copy of the complete Request for Applications (RFA) contact Cynthia Polit, Grants Management Specialist, Division of VerDate Aug<18>2005 15:05 Sep 06, 2005 Jkt 205001 Contracts and Grants Management (HFA–500), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–7180, email: cynthia.polit@fda.gov or cpolit@oc.fda.gov. This RFA can be viewed on Grants.gov under ‘‘Grant Find.’’ A copy of the complete RFA can also be viewed on the FDA/CFSAN website at https://www.cfsan.fda.gov/ list.html. For issues regarding the programmatic aspects of this notice: Wendy Buckler, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–1926, email: wendy.buckler@fda.gov. Dated: September 1, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–17731 Filed 9–6–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2001D–0044] 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 the availability of the draft guidance entitled ‘‘Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications.’’ FDA is issuing this draft guidance to recommend an approach for determining whether a laboratory test may be performed by laboratories with a certificate of waiver under CLIA. This draft guidance replaces the previous draft guidance entitled ‘‘Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver,’’ March 1, 2001. DATES: Submit written or electronic comments on this draft guidance by December 6, 2005. Submit written comments on the information collection provisions by November 7, 2005. ADDRESSES: Submit written requests for single copies on a 3.5″ diskette of the draft guidance document entitled ‘‘Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) for Waiver Applications’’ PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 53231 to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one selfaddressed adhesive label to assist that office in processing your request, or fax your request to 301–443–8818. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft guidance and the information collection provisions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Carol Benson, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–0443, ext. 144. SUPPLEMENTARY INFORMATION: I. Background 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. 263(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 under CLIA whether particular tests (waived tests) are ‘‘simple’’ and have ‘‘an insignificant risk of an erroneous result’’ (April 27, 2004, 69 FR 22849). This draft 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). FDA previously issued a draft guidance entitled ‘‘Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver’’ on March 1, 2001. This new draft guidance replaces the previous draft guidance. The changes compared to the previous draft guidance include the following: (1) Greater emphasis on scientifically-based flex studies and validation studies, linked to the hazard analysis for each device; (2) recognition that reference methods may not be E:\FR\FM\07SEN1.SGM 07SEN1 53232 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices available for every device type (although devices should be traceable to methods of known accuracy when true reference methods are available); (3) additional emphasis on use of quality control procedures; (4) greater emphasis on intended users during studies testing the device; and (5) updated study recommendations with emphasis on use of patient specimens, in an intended use environment, over time. FDA bases the recommendations in this draft guidance on its interpretation of CLIA, FDA’s experience with CLIA complexity determinations, and the agency’s interactions with stakeholders. One of the interactions with stakeholders was at an open public workshop on August 14 and 15, 2000. In addition, a proposal presented by (Advanced Medical Technology Association) AdvaMed at the September 2003 Clinical Laboratory Improvement Advisory Committee (CLIAC) meeting, and recommendations proposed by CLIAC during the February 2004 meeting were considered in the development of this guidance. manufacturers’ addresses), small manufacturer’s assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. IV. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (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 II. Significance of Guidance U.S.C. 3506(c)(2)(A)) requires Federal This draft guidance is being issued agencies to provide a 60-day notice in consistent with FDA’s good guidance the Federal Register concerning each proposed collection of information practices regulation (21 CFR 10.115). before submitting the collection to OMB The draft guidance when finalized will for approval. To comply with this represent the agency’s current thinking requirement, FDA is publishing notice on recommendations for CLIA Waiver of the proposed collection of Applications. It does not create or information set forth in this document. confer any rights for or on any person With respect to the following and does not operate to bind FDA or the collection of information, FDA invites public. An alternative approach may be comments on the following topics: (1) used if such approach satisfies the Whether the proposed collection of requirements of the applicable statute information is necessary for the proper and regulations. performance of FDA’s functions, III. Electronic Access including whether the information will To receive ‘‘Clinical Laboratory have practical utility; (2) the accuracy of Improvement Amendments of 1988 FDA’s estimate of the burden of the (CLIA) Waiver Applications,’’ you may proposed collection of information, either send a fax request to 301–443– including the validity of the 8818 to receive a hard copy of the methodology and assumptions used; (3) document, or send an e-mail request to ways to enhance the quality, utility, and gwa@cdrh.fda.gov to receive a hard copy clarity of the information to be or an electronic copy. Please use the collected; and (4) ways to minimize the document number (1171) to identify the burden of the collection of information guidance you are requesting. on respondents, including through the Persons interested in obtaining a copy use of automated collection techniques, of the draft guidance may also do so by when appropriate, and other forms of using the Internet. CDRH maintains an information technology. entry on the Internet for easy access to Title: Recommendations for CLIA information including text, graphics, Waiver Applications Description: Congress passed the and files that may be downloaded to a personal computer with Internet access. CLIA (Public Law 100–578) in 1988 to establish quality standards for all Updated on a regular basis, the CDRH home page includes device safety alerts, laboratory testing. The purpose was to ensure the accuracy, reliability, and Federal Register reprints, information timeliness of patient test results on premarket submissions (including regardless of where the test took place. lists of approved applications and VerDate Aug<18>2005 15:05 Sep 06, 2005 Jkt 205001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 CLIA requires that clinical laboratories obtain a certificate from the Secretary of Health and Human Services 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). 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. The guidance also makes 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 below. The recommendation for quick reference instructions is a new information collection which FDA is submitting to OMB for review. Quick reference instructions are a short version of the instructions that are written in simple language and 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 with this provision is approved under OMB control number 0910–0437. Respondents to this collection of information are manufacturers of in vitro diagnostic devices. FDA estimates the burden of this collection as follows. E:\FR\FM\07SEN1.SGM 07SEN1 53233 Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Annual Frequency per Response Total Annual Responses Hours per response Total Hours Operating and Maintenance Costs 1 40 780 31,200 $5,500 40 1There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours Operating and Maintenance Costs 1 40 2,800 112,000 $60,700 40 1There are no capital costs or operating and maintenance costs associated with this collection of information. Based on previous years’ 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 recordkeeping burdens for respondents is estimated to be 112,000 hours. FDA based the reporting and recordkeeping burden on an agency analysis of premarket submissions with clinical trials similar to the waived laboratory tests. The total operating and maintenance cost associated with the implementation of this draft guidance is estimated to be $66,200. The cost consists of specimen collection for the clinical study (estimated at $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 ($10,000). V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: August 31, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–17732 Filed 9–1–05; 4:00 pm] BILLING CODE 4160–01–S VerDate Aug<18>2005 15:05 Sep 06, 2005 Jkt 205001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0334] Draft Guidance for Industry on the Pediatric Research Equity Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘How to Comply with the Pediatric Research Equity Act.’’ This draft guidance provides recommendations on how to interpret the requirements of the Pediatric Research Equity Act (PREA), which requires pediatric studies of certain drugs and biological products to ensure that those products that are likely to be commonly used in children or that represent a meaningful therapeutic benefit over existing treatments contain adequate pediatric labeling for approved indications. DATES: Submit written or electronic comments on the draft guidance by November 7, 2005. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; or to the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your requests. The draft guidance may also be obtained PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 by mail by calling CBER at 1–800–835– 4709 or 301–827–1800. Submit written comments on the draft guidance to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.fda.gov/dockets/ ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Grace Carmouze, Center for Drug Evaluation and Research (HFD– 950), Food and Drug Administration,5600 Fishers Lane, Rockville, MD 20857, 301–594– 2041, or Leonard Wilson, Center for Biologics Evaluation and Research (HFM–25), Food and Drug Administration, 1401 Rockville Pike, suite 200N Rockville, MD 20852–1448, 301– 827–0373. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘How to Comply with the Pediatric Research Equity Act.’’ On December 3, 2003, the Pediatric Research Equity Act was signed into law. PREA amends the Federal Food, Drug, and Cosmetic Act (the act) by adding section 505B (21 U.S.C. 355B). In PREA, Congress codified many of the elements of the Pediatric Rule, a final rule issued by FDA on December 2, 1998 (63 FR 66632), and suspended by court order on October 17, 2002. Association of American Physicians, and Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204 (D.D.C. 2002). Specifically, PREA, in adding section 505B(a) of the act, requires all applications (or supplements to an application) submitted under section 505 of the act (21 U.S.C. 355) or section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262) for a new active ingredient, new indication, new dosage form, new dosing regimen, or E:\FR\FM\07SEN1.SGM 07SEN1

Agencies

[Federal Register Volume 70, Number 172 (Wednesday, September 7, 2005)]
[Notices]
[Pages 53231-53233]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17732]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2001D-0044]

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 the
availability of the draft guidance entitled ``Recommendations for
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver
Applications.'' FDA is issuing this draft guidance to recommend an
approach for determining whether a laboratory test may be performed by
laboratories with a certificate of waiver under CLIA. This draft
guidance replaces the previous draft guidance entitled ``Guidance for
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for
Waiver,'' March 1, 2001.

DATES: Submit written or electronic comments on this draft guidance by
December 6, 2005. Submit written comments on the information collection
provisions by November 7, 2005.

ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance document entitled ``Recommendations for
Clinical Laboratory Improvement Amendments of 1988 (CLIA) for Waiver
Applications'' to the Division of Small Manufacturers, International,
and Consumer Assistance (HFZ-220), Center for Devices and Radiological
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD
20850. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 301-443-8818. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit written comments concerning this draft guidance and the
information collection provisions to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to https://www.fda.gov/
dockets/ecomments. Identify comments with the docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Carol Benson, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-0443, ext. 144.

SUPPLEMENTARY INFORMATION:

I. Background

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. 263(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 under CLIA whether
particular tests (waived tests) are ``simple'' and have ``an
insignificant risk of an erroneous result'' (April 27, 2004, 69 FR
22849). This draft 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).
FDA previously issued a draft guidance entitled ``Clinical
Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver''
on March 1, 2001. This new draft guidance replaces the previous draft
guidance.
The changes compared to the previous draft guidance include the
following: (1) Greater emphasis on scientifically-based flex studies
and validation studies, linked to the hazard analysis for each device;
(2) recognition that reference methods may not be

[[Page 53232]]

available for every device type (although devices should be traceable
to methods of known accuracy when true reference methods are
available); (3) additional emphasis on use of quality control
procedures; (4) greater emphasis on intended users during studies
testing the device; and (5) updated study recommendations with emphasis
on use of patient specimens, in an intended use environment, over time.
FDA bases the recommendations in this draft guidance on its
interpretation of CLIA, FDA's experience with CLIA complexity
determinations, and the agency's interactions with stakeholders. One of
the interactions with stakeholders was at an open public workshop on
August 14 and 15, 2000. In addition, a proposal presented by (Advanced
Medical Technology Association) AdvaMed at the September 2003 Clinical
Laboratory Improvement Advisory Committee (CLIAC) meeting, and
recommendations proposed by CLIAC during the February 2004 meeting were
considered in the development of this guidance.

II. Significance of Guidance

This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance when
finalized will represent the agency's current thinking on
recommendations for CLIA Waiver Applications. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.

III. Electronic Access

To receive ``Clinical Laboratory Improvement Amendments of 1988
(CLIA) Waiver Applications,'' you may either send a fax request to 301-
443-8818 to receive a hard copy of the document, or send an e-mail
request to gwa@cdrh.fda.gov to receive a hard copy or an electronic
copy. Please use the document number (1171) to identify the guidance
you are requesting.
Persons interested in obtaining a copy of the draft guidance may
also do so by using the Internet. CDRH maintains an entry on the
Internet for easy access to information including text, graphics, and
files that may be downloaded to a personal computer with Internet
access. Updated on a regular basis, the CDRH home page includes device
safety alerts, Federal Register reprints, information on premarket
submissions (including lists of approved applications and
manufacturers' addresses), small manufacturer's assistance, information
on video conferencing and electronic submissions, Mammography Matters,
and other device-oriented information. The CDRH Web site may be
accessed at https://www.fda.gov/cdrh. A search capability for all CDRH
guidance documents is available at https://www.fda.gov/cdrh/
guidance.html. Guidance documents are also available on the Division of
Dockets Management Internet site at https://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (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 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 the following 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.
Title: Recommendations for CLIA Waiver Applications
Description: 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 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). 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. The
guidance also makes 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 below. The recommendation for quick reference instructions is
a new information collection which FDA is submitting to OMB for review.
Quick reference instructions are a short version of the instructions
that are written in simple language and 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 with this provision is approved under OMB control
number 0910-0437.
Respondents to this collection of information are manufacturers of
in vitro diagnostic devices.
FDA estimates the burden of this collection as follows.

[[Page 53233]]

Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per Operating and Maintenance
No. of Respondents Response Total Annual Responses Hours per response Total Hours Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
40 1 40 780 31,200 $5,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per Operating and Maintenance
No. of Recordkeepers Recordkeeping Total Annual Records Hours per Record Total Hours Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
40 1 40 2,800 112,000 $60,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on previous years' 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 recordkeeping burdens for respondents is estimated to be 112,000
hours. FDA based the reporting and recordkeeping burden on an agency
analysis of premarket submissions with clinical trials similar to the
waived laboratory tests.
The total operating and maintenance cost associated with the
implementation of this draft guidance is estimated to be $66,200. The
cost consists of specimen collection for the clinical study (estimated
at $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
($10,000).

V. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

Dated: August 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17732 Filed 9-1-05; 4:00 pm]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.