E7-9435. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1988 Categorization

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 June 15, 2007.

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]. All comments should be identified with the OMB Control Number 0910-NEW and the title “Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1988 Categorization.” Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Jr., Office of the Chief Information Officer (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:

Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1988 Categorization (42 CFR 493.17)

A draft guidance document entitled “Guidance for Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization” (CLIA) was released for comment on August 14, 2000. The document describes procedures FDA will use to assign the complexity category to a device. Typically, FDA assigns complexity categorizations to devices at the time of clearance or approval of the device. In this way, no additional burden is incurred by the manufacturer since the labeling (including operating instructions) is included in the 510(k) or premarket approval (PMA). In some cases, however, a manufacturer may request CLIA categorization even if FDA is not simultaneously reviewing a 510(k) or PMA. One example is when a manufacturer requests that FDA assign CLIA categorization to a previously cleared device that has changed names since the original CLIA categorization. Another example is when a device is exempt from premarket review. In such cases, the guidance recommends that manufacturers provide FDA with a copy of the package insert for the device and a cover letter indicating why the manufacturer is requesting a categorization (e.g., name change exempt from 510(k) review). The draft guidance recommends that in the correspondence to FDA the manufacturer should identify the product code and classification as well as reference to the original 510(k) when this is available.

A previous 60-day notice that published August 14, 2000 (65 FR 49582), announced the availability of a draft guidance and did not include a Paperwork Analysis Section. This 60-day notice for public comment supersedes that notice and is correcting that error.

In the Federal Register of February 14, 2007 (72 FR 7043), FDA published a 60-day notice soliciting public comment on the proposed collection of information requirements. In response to that notice, no comments were received.

The likely respondents for this collection are Investigational New Drug Application sponsors.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden¹

42 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours	Total Operating & Maintenance Costs
493.17	60	15	900	1	900	$45,000
Total	60	15	900	1	900	$45,000
1 There are no capital costs associated with this collection of information.

The number of respondents is approximately 60. On average, each respondent will request categorizations (independent of a 510(k) or PMA) 15 times per year. The cost, not including personnel, is estimated at $50. This includes the cost of copying and mailing copies of package inserts and a cover letter, which includes a statement of the reason for the request and reference to the original 510(k) numbers, including regulation numbers and product codes.

Dated: May 10, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.