Document ID: FDA-2013-N-0514-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments Categorization
Posted Date: 2019-10-25T04:00Z

[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57443-57444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23274]

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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; Administrative 
Procedures 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 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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. 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, 
PRAStaff@fda.hhs.gov.

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

[[Page 57444]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                        Number of                                                        Total operating
                     Activity                          Number of      responses per     Total annual    Average burden    Total hours    and maintenance
                                                      respondents       respondent       responses       per response                         costs
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Request for CLIA categorization...................              80                5              400                1              400           $2,000
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\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 x 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.
[FR Doc. 2019-23274 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P