[Federal Register Volume 78, Number 179 (Monday, September 16, 2013)]
[Page 56899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22443]



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.


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 
16, 2013.

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.

Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [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 (CLIA) 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 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 May 22, 2013 (78 FR 30312), 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 

                                                 Table 1--Estimated Annual Reporting Burden Activity \1\
                                                                        Number of                                                         Operating and
                     Activity                          Number of      responses per     Total annual    Average burden    Total hours      maintenance
                                                      respondents       respondent       responses      per  response                         costs
Request for CLIA categorization...................              60               15              900                1              900          $46,800
\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: September 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22443 Filed 9-13-13; 8:45 am]