[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Notices]
[Page 61685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0514]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Requests for Clinical 
Laboratory Improvement Amendments Categorization

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 
7, 2016.

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: 202-395-7285, or emailed to [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

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.

Requests for Clinical Laboratory Improvement Amendments of 1988 
Categorization--42 CFR 493.17--OMB Control Number 0910-0607--Extension

    A guidance document entitled ``Guidance for Administrative 
Procedures for CLIA Categorization'' was released on May 7, 2008. The 
document describes procedures FDA uses 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 because the 
labeling (including operating instructions) is included in the 
premarket notification (510(k)) or premarket approval application 
(PMA). In some cases, however, a manufacturer may request Clinical 
Laboratory Improvement Amendments of 1998 (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 
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 April 27, 2016 (81 FR 24820), 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\
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                                                                                                                                               Total
                                                             Number of       Number of     Total annual       Average                      operating and
                        Activity                            respondents    responses per     responses      burden per      Total hours     maintenance
                                                                            respondent                       response                          costs
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Request for CLIA Categorization.........................              60              15             900               1             900         $46,800
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\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 $52 per hour (52 x 900), totaling $46,800. 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. 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).

    Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21352 Filed 9-6-16; 8:45 am]
 BILLING CODE 4164-01-P