84 FR 30127 - Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments Categorization

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 administrative procedures for Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization of certain in vitro diagnostic tests.

[Federal Register Volume 84, Number 123 (Wednesday, June 26, 2019)]
[Notices]
[Pages 30127-30129]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2019-13561]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 administrative procedures for Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) categorization of 
certain in vitro diagnostic tests.

DATES: Submit either electronic or written comments on the collection 
of information by August 26, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 26, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 26, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0514 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Administrative Procedures for 
Clinical Laboratory Improvement Amendments Categorization.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed

[[Page 30128]]

except in accordance with 21 CFR 10.20 and other applicable disclosure 
law. For more information about FDA's posting of comments to public 
dockets, see 80 FR 56469, September 18, 2015, or access the information 
at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations .gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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, 
[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.

Administrative Procedures for CLIA Categorization--42 CFR 493.17

OMB Control Number 0910-0607--Extension

    FDA's ``Guidance for Administrative Procedures for CLIA 
Categorization'' \1\ describes procedures FDA uses to assign the 
complexity category to a device, which affects what type of 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 
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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    FDA estimates the burden of this collection of information as 
follows:

                                                     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.


[[Page 30129]]


    Dated: June 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13561 Filed 6-25-19; 8:45 am]
BILLING CODE 4164-01-P