2019-23274. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments Categorization

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or we) 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 November 25, 2019.

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], or emailed to [e-mail]. All comments should be identified with the OMB control number 0910-0607. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [e-mail].

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 Clinical Laboratory Improvement Amendments of 1988 Categorization—42 CFR 493.17

OMB Control Number 0910-0607—Extension

FDA's guidance entitled “Administrative Procedures for CLIA Categorization”^[1] describes procedures FDA uses to assign the complexity category to a device, which affects what type of Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate the laboratory obtains. Typically, FDA assigns complexity categorizations to devices at the time of clearance or approval of the device. In some cases, however, a manufacturer may request CLIA categorization even if FDA is not simultaneously reviewing a 510(k) or premarket approval application (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 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.

In the Federal Register of June 26, 2019 (84 FR 30127), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

Table 1—Estimated Annual Reporting Burden ¹

Activity	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours	Total operating and maintenance costs
Request for CLIA categorization	80	5	400	1	400	$2,000
1 There are no capital costs associated with this collection of information.

Based on recent receipt data for requests for CLIA categorization separate from a product application, the number of respondents is approximately 80. On average, each respondent requests such categorizations five times per year.

The cost, not including personnel, is estimated at $5 per submission (5 × 400), totaling $2,000. This includes the cost of copying and mailing copies of package inserts and a cover letter. The burden hours are based on FDA familiarity with the types of documentation typically included in a sponsor's categorization requests, and costs for basic office supplies (e.g., paper). Upon review of this information collection, we have adjusted the estimated cost per submission (previously $52). Because the submissions are typically only a few pages per package insert and copying or printing and postage for a few pages is not expected to be more than $5, we believe this is a more appropriate cost burden estimate.

Our estimated burden for the information collection reflects an overall decrease of 500 hours. We attribute this adjustment to a decrease in the number of submissions we received over the last few years. Also, upon review of this information collection, we believe the previous estimate may have included requests for categorization associated with a premarket submission, the burden estimate of which is included under the OMB approval for the applicable premarket submission. We have therefore revised the number of respondents/responses to include only those that are separate from a product application, consistent with the scope of this information collection.

Dated: October 18, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

Footnotes

1.  Available at https://www.fda.gov/​media/​71065/​download.