[Federal Register Volume 78, Number 99 (Wednesday, May 22, 2013)]
[Pages 30312-30313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12099]



Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on requests for Clinical 
Laboratory Improvement Amendments of 1998 (CLIA) categorization of in 
vitro diagnostic (IVD) tests when a premarket review is not needed.

DATES: Submit either electronic or written comments on the collection 
of information by July 22, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Requests for CLIA Categorization--42 CFR 493.17 (OMB Control Number 

    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

[[Page 30313]]

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.
    FDA estimates the burden of this collection of information as 

                                                     Table 1--Estimated Annual Reporting Burden \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

    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: May 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12099 Filed 5-21-13; 8:45 am]