E6-15693. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Clinical Laboratory Improvement ...

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: [phone].

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Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Clinical Laboratory Improvement Amendments (CLIA) of 1988 Waiver Applications;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 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	Total Annual Responses	Hours per Response	Total Hours	Total Operating & 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 Burden¹

No. of Recordkeepers	Annual Frequency per Recordkeeper	Total Annual Records	Hours per Record	Total Hours	Total Operating & 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.