81 FR 18858 - Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical Laboratory Improvement Amendments Act of 1988 Waiver Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 63 (April 1, 2016)

Page Range		18858-18860
FR Document		2016-07365

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 collections of information associated with Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver applications.

Federal Register, Volume 81 Issue 63 (Friday, April 1, 2016)

[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Pages 18858-18860]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-07365]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0031]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Clinical Laboratory Improvement Amendments Act of 1988 
Waiver Applications

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 collections of information 
associated with Clinical Laboratory Improvement Amendments of 1988 
(CLIA) waiver applications.

DATES: Submit either electronic or written comments on the collection 
of information by May 31, 2016.

ADDRESSES: You may submit comments as follows:

[[Page 18859]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2008-D-0031 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; CLIA Waiver Applications.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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.

CLIA Waiver Applications--OMB Control Number 0910-0598--Extension

    Congress passed the CLIA (Pub. L. 100-578) in 1988 to establish 
quality standards for all laboratory testing. The purpose was to ensure 
the accuracy, reliability, and timeliness of patient test results 
regardless of where the test took place. CLIA requires that clinical 
laboratories obtain a certificate from the Secretary of Health and 
Human Services (the Secretary), before accepting materials derived from 
the human body for laboratory tests (42 U.S.C. 263a(b)). Laboratories 
that perform only tests that are ``simple'' and that have an 
``insignificant risk of an erroneous result'' may obtain a certificate 
of waiver (42 U.S.C. 263a(d)(2)). The Secretary has delegated to FDA 
the authority to determine whether particular tests (waived tests) are 
``simple'' and have ``an insignificant risk of an erroneous result'' 
under CLIA (69 FR 22849, April 27, 2004).
    On January 30, 2008, FDA published a guidance document entitled 
``Guidance for Industry and FDA Staff: Recommendations for Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications 
for Manufacturers of In Vitro Diagnostic Devices'' (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079632.htm). This guidance document describes recommendations for 
device manufacturers submitting to FDA an application for determination 
that a cleared or approved device meets this CLIA standard (CLIA waiver 
application). The guidance recommends that CLIA waiver applications 
include a description of the features of the device

[[Page 18860]]

that make it ``simple''; a report describing a hazard analysis that 
identifies potential sources of error, including a summary of the 
design and results of flex studies and conclusions drawn from the flex 
studies; a description of fail-safe and failure alert mechanisms and a 
description of the studies validating these mechanisms; a description 
of clinical tests that demonstrate the accuracy of the test in the 
hands of intended operators; and statistical analyses of clinical study 
results.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of                                                        Total operating
                     Activity                          Number of      responses per     Total annual    Average burden    Total hours    and maintenance
                                                      respondents       respondent       responses       per response                         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
CLIA waiver application...........................              40                1               40            1,200           48,000         $350,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
CLIA waiver records................................................              40                1               40            2,800          112,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The total number of reporting and recordkeeping hours is 160,000 
hours. FDA bases the burden on an Agency analysis of premarket 
submissions with clinical trials similar to the waived laboratory 
tests. Based on previous years' experience with CLIA waiver 
applications, FDA expects 40 manufacturers to submit one CLIA waiver 
application per year. The time required to prepare and submit a waiver 
application, including the time needed to assemble supporting data, 
averages 1,200 hours per waiver application for a total of 48,000 hours 
for reporting. Based on previous years' experience with CLIA waiver 
applications, FDA expects that each manufacturer will spend 2,800 hours 
creating and maintaining the record for a total of 112,000 hours.
    The total operating and maintenance cost associated with the waiver 
application is estimated at $350,000. This cost is largely attributed 
to clinical study costs incurred, which include site selection and 
qualification, protocol review, and study execution (initiation, 
monitoring, closeout, and clinical site/subject compensation--including 
specimen collection for study as well as shipping and supplies).

    Dated: March 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07365 Filed 3-31-16; 8:45 am]
BILLING CODE 4164-01-P

18858 Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices

ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response

LIHEAP Leveraging Report ............................................................................. 70 1 38 2,660

Estimated Total Annual Burden SUMMARY: The Food and Drug FDA has received notice of the
Hours: 2,660. Administration (FDA) is publishing following complaint under section
In compliance with the requirements notice that an applicant for a proposed 351(l)(6)(C) of the PHS Act:
of Section 506(c)(2)(A) of the Paperwork biosimilar product notified FDA that a Amgen, Inc., v. Apotex, Inc., 15–cv–
Reduction Act of 1995, the patent infringement action was filed in 61631 (consolidated with 15–cv–62081,
Administration for Children and connection with the applicant’s S.D. Fla., filed October 2, 2015).
Families is soliciting public comment biologics license application (BLA). FDA has only a ministerial role in
on the specific aspects of the Under the Public Health Service Act publishing notice of a complaint
information collection described above. (PHS Act), an applicant for a proposed received under section 351(l)(6)(C) of
Copies of the proposed collection of biosimilar product or interchangeable the PHS Act, and does not perform a
information can be obtained and product must notify FDA within 30 days substantive review of the complaint.
comments may be forwarded by writing after the applicant was served with a
to the Administration for Children and Dated: March 25, 2016.
complaint in a patent infringement Leslie Kux,
Families, Office of Planning, Research action described under the PHS Act.
and Evaluation, 330 C Street SW., Associate Commissioner for Policy.
FDA is required to publish notice of the
Washington DC 20201. Attn: ACF [FR Doc. 2016–07364 Filed 3–31–16; 8:45 am]
complaint in the Federal Register.
Reports Clearance Officer. Email BILLING CODE 4164–01–P
address: infocollection@acf.hhs.gov. All FOR FURTHER INFORMATION CONTACT:
requests should be identified by the title Daniel Orr, Center for Drug Evaluation
of the information collection. and Research, Food and Drug DEPARTMENT OF HEALTH AND
The Department specifically requests Administration, 10903 New Hampshire HUMAN SERVICES
comments on: (a) Whether the proposed Ave., Bldg. 51, Rm. 6208, Silver Spring,
collection of information is necessary Food and Drug Administration
MD 20993–0002, 240–402–0979,
for the proper performance of the daniel.orr@fda.hhs.gov.
functions of the agency, including [Docket No. FDA–2008–D–0031]
whether the information shall have SUPPLEMENTARY INFORMATION: The
practical utility; (b) the accuracy of the Biologics Price Competition and Agency Information Collection
agency’s estimate of the burden of the Innovation Act of 2009 (BPCI Act) was Activities; Proposed Collection;
proposed collection of information; (c) enacted as part of the Patient Protection Comment Request; Clinical Laboratory
the quality, utility, and clarity of the and Affordable Care Act (Pub. L. 111– Improvement Amendments Act of 1988
information to be collected; and (d) 148) on March 23, 2010. The BPCI Act Waiver Applications
ways to minimize the burden of the amended the PHS Act and created an
abbreviated licensure pathway for AGENCY: Food and Drug Administration,
collection of information on
HHS.
respondents, including through the use biological products shown to be
of automated collection techniques or biosimilar to, or interchangeable with, ACTION: Notice.
other forms of information technology. an FDA-licensed biological reference
Consideration will be given to product. Section 351(k) of the PHS Act SUMMARY: The Food and Drug
comments and suggestions submitted (42 U.S.C. 262(k)), added by the BPCI Administration (FDA) is announcing an
within 60 days of this publication. Act, describes the requirements for a opportunity for public comment on the
BLA for a proposed biosimilar product proposed collection of certain
Robert Sargis, information by the Agency. Under the
or a proposed interchangeable product
Reports Clearance Officer. Paperwork Reduction Act of 1995 (the
(351(k) BLA). Section 351(l) of the PHS
[FR Doc. 2016–07359 Filed 3–31–16; 8:45 am] PRA), Federal Agencies are required to
Act, also added by the BPCI Act,
BILLING CODE 4184–01–P publish notice in the Federal Register
describes certain procedures for
concerning each proposed collection of
exchanging patent information and information, including each proposed
DEPARTMENT OF HEALTH AND resolving patent disputes between a extension of an existing collection of
HUMAN SERVICES 351(k) BLA applicant and the holder of information, and to allow 60 days for
the BLA reference product. If a 351(k) public comment in response to the
Food and Drug Administration applicant is served with a complaint for notice. This notice solicits comments on
a patent infringement described in collections of information associated
[Docket No. FDA–2015–N–2489] section 351(l)(6) of the PHS Act, the
asabaliauskas on DSK3SPTVN1PROD with NOTICES

with Clinical Laboratory Improvement
applicant is required, under section Amendments of 1988 (CLIA) waiver
Receipt of Notice That a Patent 351(l)(6)(C) of the PHS Act, to provide applications.
Infringement Complaint Was Filed the FDA with notice and a copy of the
Against a Biosimilar Applicant complaint within 30 days of service. DATES: Submit either electronic or
FDA is required to publish notice of a written comments on the collection of
AGENCY: Food and Drug Administration, information by May 31, 2016.
HHS. complaint received under section
351(l)(6)(C) of the PHS Act in the ADDRESSES: You may submit comments
ACTION: Notice.
Federal Register. as follows:

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18860 Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices

that make it ‘‘simple’’; a report description of fail-safe and failure alert statistical analyses of clinical study
describing a hazard analysis that mechanisms and a description of the results.
identifies potential sources of error, studies validating these mechanisms; a FDA estimates the burden of this
including a summary of the design and description of clinical tests that collection of information as follows:
results of flex studies and conclusions demonstrate the accuracy of the test in
drawn from the flex studies; a the hands of intended operators; and

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total
Number of Total Average
Number of operating and
Activity responses per annual burden per Total hours
respondents maintenance
respondent responses response costs

CLIA waiver application ........................... 40 1 40 1,200 48,000 $350,000
1 There are no capital costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

CLIA waiver records ............................................................ 40 1 40 2,800 112,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The total number of reporting and DEPARTMENT OF HEALTH AND FDA is announcing the renewal of the
recordkeeping hours is 160,000 hours. HUMAN SERVICES Arthritis Advisory Committee (the
FDA bases the burden on an Agency Committee). The Committee is a
analysis of premarket submissions with Food and Drug Administration discretionary Federal advisory
clinical trials similar to the waived [Docket No. FDA–2016–N–0001] committee established to provide advice
laboratory tests. Based on previous to the Commissioner. The Committee
years’ experience with CLIA waiver Advisory Committee; Arthritis advises the Commissioner or designee
applications, FDA expects 40 Advisory Committee, Renewal in discharging responsibilities as they
manufacturers to submit one CLIA relate to helping to ensure safe and
AGENCY: Food and Drug Administration, effective drugs for human use and, as
waiver application per year. The time
HHS. required, any other product for which
required to prepare and submit a waiver
application, including the time needed ACTION:Notice; renewal of advisory FDA has regulatory responsibility. The
to assemble supporting data, averages committee. Committee reviews and evaluates data
1,200 hours per waiver application for SUMMARY: The Food and Drug concerning the safety and effectiveness
a total of 48,000 hours for reporting. Administration (FDA) is announcing the of marketed and investigational human
Based on previous years’ experience renewal of the Arthritis Advisory drug products for use in the treatment
with CLIA waiver applications, FDA Committee by the Commissioner of of arthritis, rheumatism, and related
expects that each manufacturer will Food and Drugs (the Commissioner). diseases, and makes appropriate
spend 2,800 hours creating and The Commissioner has determined that recommendations to the Commissioner.
maintaining the record for a total of it is in the public interest to renew the The Committee shall consist of a core
112,000 hours. Arthritis Advisory Committee for an of 11 voting members including the
The total operating and maintenance additional 2 years beyond the charter Chair. Members and the Chair are
cost associated with the waiver expiration date. The new charter will be selected by the Commissioner or
application is estimated at $350,000. in effect until April 5, 2018. designee from among authorities
This cost is largely attributed to clinical DATES: Authority for the Arthritis knowledgeable in the fields of arthritis,
study costs incurred, which include site Advisory Committee will expire on rheumatology, orthopedics,
selection and qualification, protocol April 5, 2018, unless the Commissioner epidemiology or statistics, analgesics,
review, and study execution (initiation, formally determines that renewal is in and related specialties. Members will be
monitoring, closeout, and clinical site/ the public interest. invited to serve for overlapping terms of
subject compensation—including FOR FURTHER INFORMATION CONTACT: up to 4 years. Almost all non-Federal
specimen collection for study as well as Stephanie L. Begansky, Center for Drug members of this committee serve as
shipping and supplies). Evaluation and Research, Food and Special Government Employees. The
Drug Administration, 10903 New core of voting members may include one
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Dated: March 25, 2016. Hampshire Ave., Bldg. 31, Rm. 2417, technically qualified member, selected
Leslie Kux, Silver Spring, MD 20993–0002, 301– by the Commissioner or designee, who
Associate Commissioner for Policy. 796–9001, AAC@fda.hhs.gov. is identified with consumer interests
[FR Doc. 2016–07365 Filed 3–31–16; 8:45 am] SUPPLEMENTARY INFORMATION: Pursuant and is recommended by either a
BILLING CODE 4164–01–P to 41 CFR 102–3.65 and approval by the consortium of consumer-oriented
Department of Health and Human organizations or other interested
Services pursuant to 45 CFR part 11 and persons. In addition to the voting
by the General Services Administration, members, the Committee may include

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Document Created: 2016-04-06 00:08:22
Document Modified: 2016-04-06 00:08:22

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by May 31, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		81 FR 18858

81 FR 18858 - Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical Laboratory Improvement Amendments Act of 1988 Waiver Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 63 (April 1, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration