Guidance for Industry and Food and Drug Administration Staff; Clinical Laboratory Improvement Amendments of 1988: Recommendations for Clinical Laboratory Improvement Amendments of 1988: Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Availability, 5574-5575 [E8-1557]

Download as PDF 5574 Federal Register / Vol. 73, No. 20 / Wednesday, January 30, 2008 / Notices programs is in Title IV of the Community Opportunities, Accountability and Training and Educational Services Act (COATS Human Services Reauthorization Act) of October 27, 2998, Pub. L. 105–285, section 680(b) as amended. The questionnaire will collect information concerning its outcomes and management. OCS will use the data to critically review the overall design and effectiveness of each program. Respondents: OCS Grantees. ANNUAL BURDEN ESTIMATES Instrument Number of respondents Questionnaire for OCS–JOLI Grantees in the US .................. Questionnaire for OCS–CED Grantees in the US .................. 25 JOLI grantees ................... 147 CED grantees ................. Estimated Total Annual Burden Hours: Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202– 395–6974, Attn: Desk Officer for the Administration for Children and Families. Dated: January 23, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. 08–384 Filed 1–29–08; 8:45 am] BILLING CODE 4184–01–M mstockstill on PROD1PC66 with NOTICES Number of responses per respondent VerDate Aug<31>2005 18:49 Jan 29, 2008 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0031] (formerly Docket No. 2001D–0044) Guidance for Industry and Food and Drug Administration Staff; Clinical Laboratory Improvement Amendments of 1988: Recommendations for Clinical Laboratory Improvement Amendments of 1988: Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.’’ FDA is issuing this guidance to recommend approaches for determining whether a laboratory test may be performed by laboratories with a certificate of waiver under CLIA. DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’ 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 240–276– 3151. See the SUPPLEMENTARY SUMMARY: PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 1 1 Average burden hours per response 1.5 1.5 Total burden hours 37.5 220.5 INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this 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.regulations.gov. 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,2098 Gaither Rd., Rockville, MD 20850, 240–276– 0396. 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’’ (69 FR 22849, April 27, 2004). This guidance describes recommendations for device manufacturers seeking to submit information (CLIA waiver application) to FDA to support a determination that a cleared or approved in vitro diagnostic (IVD) device meets this CLIA waiver standard. In the guidance document, FDA recommends an approach for manufacturers to demonstrate in a CLIA waiver application that a device is simple and has an insignificant risk of erroneous result as required under CLIA (42 U.S.C. 263a). FDA based the recommendations in the guidance E:\FR\FM\30JAN1.SGM 30JAN1 Federal Register / Vol. 73, No. 20 / Wednesday, January 30, 2008 / Notices document on interpretation of the law, experience with CLIA complexity determinations, and comments and information from stakeholders. The draft of this guidance was issued September 7, 2005 (70 FR 53231). FDA received and considered approximately 40 sets of comments on the draft guidance document. After taking the comments into consideration, FDA has updated the document to provide clarifications as needed. The guidance has also been revised to allow for additional supplementation of the actual patient specimens in the clinical study with alternative samples, preferably banked patient samples. The revised guidance recommends that, when neither patient specimens nor banked samples are available, it may be acceptable to supplement with other types of prepared samples, e.g., spiked, or diluted samples that mimic patient samples in terms of analyte and matrix. The revised guidance specifies that up to a total of one third of the clinical study samples may be supplemented with these types of alternative samples. The revised guidance also provides more flexibility in selecting the comparator method as well as more consistency in terms of the criteria for accuracy for waived tests as compared with moderate and high complexity tests. mstockstill on PROD1PC66 with NOTICES II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on reporting results from studies evaluating diagnostic tests. 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 Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive ‘‘Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices,’’ you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 240–276–3151 to receive a hard copy. Please use the document number 1171 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that VerDate Aug<31>2005 18:49 Jan 29, 2008 Jkt 214001 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 at https://www.fda.gov/ohrms/dockets/ default.htm. IV. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in this guidance were approved under OMB control number 0910–0598. 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. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. Dated: January 22, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8–1557 Filed 1–29–08; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 5575 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; Case-Cohort Study of Cancer and Related Disorders Among Benzene-Exposed Workers in China (OMB No. 0925–0454) 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 Cancer Institute (NCI), 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. PROPOSED COLLECTION: Title: CaseCohort Study of Cancer and Related Disorders Among Benzene-Exposed Workers in China. Type of Information Collection Request: Emergency Extension. Need and Use of Information Collection: Since 1987, the National Cancer Institute has collaborated with the Chinese Academy of Preventive Medicine (currently designated Chinese Centers for Disease Control) in a factorybased investigation of cancer mortality and incidence of lymphohematopoietic disorders in a cohort of 75,000 and 36,000 comparison workers in 12 cities in China. Our initial study revealed elevated risks of leukemia, myelodysplastic syndromes, nonHodgkin lymphoma, benzene poisoning, and lung cancer among the benzeneexposed workers. During the past five years, data have been collected to enable more precise quantification of risks of the malignancies and related disorders with an additional 12 years of follow-up of the subjects using a case-control study design. Cases included all workers from the exposed and unexposed groups who were diagnosed with leukemia, myelodysplastic syndromes, non-Hodgkin lymphoma and all other hematopoietic disorders; benzene poisoning; and lung cancer. Controls were frequency matched to cases and selected from the exposed (N=1200) and unexposed (N=300) cohort members. Data have been collected from factories, hospitals, and directly from interviews of all living and next of kin of deceased cases and controls. Information collected from the interviews focuses on potential confounding exposures including smoking, non-occupational benzene exposure, level of education, medical conditions, use of specific medications, and family cancer history. This study E:\FR\FM\30JAN1.SGM 30JAN1

Agencies

[Federal Register Volume 73, Number 20 (Wednesday, January 30, 2008)]
[Notices]
[Pages 5574-5575]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-1557]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0031] (formerly Docket No. 2001D-0044)


Guidance for Industry and Food and Drug Administration Staff; 
Clinical Laboratory Improvement Amendments of 1988: Recommendations for 
Clinical Laboratory Improvement Amendments of 1988: Waiver Applications 
for Manufacturers of In Vitro Diagnostic Devices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Recommendations for Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications 
for Manufacturers of In Vitro Diagnostic Devices.'' FDA is issuing this 
guidance to recommend approaches for determining whether a laboratory 
test may be performed by laboratories with a certificate of waiver 
under CLIA.

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Recommendations for Clinical Laboratory Improvement 
Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In 
Vitro Diagnostic Devices'' 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 
240-276-3151. See the SUPPLEMENTARY INFORMATION section for information 
on electronic access to the guidance.
    Submit written comments concerning this 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.regulations.gov. 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,2098 
Gaither Rd., Rockville, MD 20850, 240-276-0396.

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'' (69 FR 22849, April 27, 
2004). This guidance describes recommendations for device manufacturers 
seeking to submit information (CLIA waiver application) to FDA to 
support a determination that a cleared or approved in vitro diagnostic 
(IVD) device meets this CLIA waiver standard.
    In the guidance document, FDA recommends an approach for 
manufacturers to demonstrate in a CLIA waiver application that a device 
is simple and has an insignificant risk of erroneous result as required 
under CLIA (42 U.S.C. 263a). FDA based the recommendations in the 
guidance

[[Page 5575]]

document on interpretation of the law, experience with CLIA complexity 
determinations, and comments and information from stakeholders.
    The draft of this guidance was issued September 7, 2005 (70 FR 
53231). FDA received and considered approximately 40 sets of comments 
on the draft guidance document. After taking the comments into 
consideration, FDA has updated the document to provide clarifications 
as needed. The guidance has also been revised to allow for additional 
supplementation of the actual patient specimens in the clinical study 
with alternative samples, preferably banked patient samples. The 
revised guidance recommends that, when neither patient specimens nor 
banked samples are available, it may be acceptable to supplement with 
other types of prepared samples, e.g., spiked, or diluted samples that 
mimic patient samples in terms of analyte and matrix. The revised 
guidance specifies that up to a total of one third of the clinical 
study samples may be supplemented with these types of alternative 
samples. The revised guidance also provides more flexibility in 
selecting the comparator method as well as more consistency in terms of 
the criteria for accuracy for waived tests as compared with moderate 
and high complexity tests.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on reporting results from studies evaluating 
diagnostic tests. 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

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. To receive ``Recommendations for Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications 
for Manufacturers of In Vitro Diagnostic Devices,'' you may either send 
an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy 
of the document or send a fax request to 240-276-3151 to receive a hard 
copy. Please use the document number 1171 to identify the guidance you 
are requesting.
    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 at https://www.fda.gov/ohrms/dockets/default.htm.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this guidance were approved under OMB 
control number 0910-0598.

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.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

    Dated: January 22, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-1557 Filed 1-29-08; 8:45 am]
BILLING CODE 4160-01-S
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