81 FR 46693 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 137 (July 18, 2016)

Page Range		46693-46694
FR Document		2016-16886

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.

Federal Register, Volume 81 Issue 137 (Monday, July 18, 2016)

[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Notices]
[Pages 46693-46694]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16886]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 August 
17, 2016.

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 0910-0598. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [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.

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

[[Page 46694]]

``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 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.
    In the Federal Register of April 1, 2016 (81 FR 18858), 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:

                                                     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: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16886 Filed 7-15-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Notices 46693

employees in ORR with access to the information pertains. Verification of DEPARTMENT OF HEALTH AND
database, and a limited number of identity as described in the HUMAN SERVICES
employees in other HHS offices, e.g., Department’s Privacy Act regulations
CDC and SAMHSA, receiving data from may be required (see 45 CFR 5b.5). If the Food and Drug Administration
ORR) who are advised of the individual data subject is a minor or is [Docket No. FDA–2008–D–0031]
confidentiality of the records and the legally incompetent, the individual’s
civil and criminal penalties for misuse. legal representative (parent or court- Agency Information Collection
Personnel with authorized access to the appointed guardian) may request access Activities; Submission for Office of
system are provided privacy and on the individual’s behalf. The Management and Budget Review;
security training for electronically representative must provide verification Comment Request; Clinical Laboratory
stored information. The records are of identity and competent evidence of Improvement Amendments Act of 1988
processed and stored in a secure the parent or guardian relationship. Waiver Applications
environment. All records are stored in CONTESTING RECORD PROCEDURES:
an area that is physically safe from AGENCY: Food and Drug Administration,
Individuals seeking to amend a record HHS.
access by unauthorized persons at all
about them in this system of records ACTION: Notice.
times. Safeguards conform to the HHS
should address the request for
Information Security Program, http://
amendment to the System Manager. The SUMMARY: The Food and Drug
www.hhs.gov/ocio/securityprivacy/
request should: Administration (FDA) is announcing
index.html. • Include the alien number, age, that a proposed collection of
RETENTION AND DISPOSAL: telephone number, and/or email address information has been submitted to the
The records will be retained of the individual, and should be signed Office of Management and Budget
indefinitely pending scheduling with by the individual to whom such (OMB) for review and clearance under
the National Archives and Records information pertains; the Paperwork Reduction Act of 1995.
• identify the system of records that DATES: Fax written comments on the
Administration (NARA). Because the
the individual believes includes his or collection of information by August 17,
records will have continuing value for
her records or otherwise provide enough 2016.
epidemiological purposes, the retention
information to enable the identification
period proposed to NARA may be 100 ADDRESSES: To ensure that comments on
of the individual’s record;
years or longer. • identify the information that the the information collection are received,
individual believes is not accurate, OMB recommends that written
SYSTEM MANAGER AND ADDRESS:
relevant, timely or complete; comments be faxed to the Office of
Director, Division of Refugee Health, Information and Regulatory Affairs,
• indicate what corrective action is
Office of Refugee Resettlement, OMB, Attn: FDA Desk Officer, FAX:
sought; and
Administration for Children and • include supporting justification or 202–395–7285, or emailed to oira_
Families, Mary E. Switzer Building, 330 documentation for the requested submission@omb.eop.gov. All
C Street SW., Washington, DC 20201. amendment. comments should be identified with the
NOTIFICATION PROCEDURE: Verification of identity as described in OMB control number 0910–0598. Also
the Department’s Privacy Act include the FDA docket number found
Individuals seeking to determine in brackets in the heading of this
regulations may be required (see 45 CFR
whether this system of records contains 5b.5). If the individual data subject is a document.
information about them should address minor or is legally incompetent, the
written inquiries to the System FOR FURTHER INFORMATION CONTACT: FDA
individual’s legal representative (parent PRA Staff, Office of Operations, Food
Manager. The request should include or court-appointed guardian) may make
the alien number, age, telephone and Drug Administration, Three White
an amendment request on the Flint North, 10A63, 11601 Landsdown
number, and/or email address of the individual’s behalf. The representative
individual data subject. The request St., North Bethesda, MD 20852,
must provide verification of identity PRAStaff@fda.hhs.gov.
must be signed by the requester. and competent evidence of the parent or
Verification of identity as described in SUPPLEMENTARY INFORMATION: In
guardian relationship.
the Department’s Privacy Act compliance with 44 U.S.C. 3507, FDA
regulations may be required (see 45 CFR RECORD SOURCE CATEGORIES: has submitted the following proposed
5b.5). If the individual data subject is a The information maintained in the collection of information to OMB for
minor or is legally incompetent, the system is provided by states and other review and clearance.
individual’s legal representative (parent resettlement organizations when they CLIA Waiver Applications—OMB
or court-appointed guardian) may report a suicide attempt using the
Control Number 0910–0598—Extension
request notification on the individual’s Refugee Suicide and Report Form. The
behalf. The representative must provide State Refugee Coordinator and State Congress passed the CLIA (Pub. L.
verification of identity and competent Refugee Health Coordinator will be 100–578) in 1988 to establish quality
evidence of the parent or guardian primarily responsible for reporting this standards for all laboratory testing. The
relationship. information. They will collect the purpose was to ensure the accuracy,
information from various sources within reliability, and timeliness of patient test
RECORD ACCESS PROCEDURES: results regardless of where the test took
asabaliauskas on DSK3SPTVN1PROD with NOTICES

the state including refugee resettlement
Individuals seeking access to a record agencies, public health departments, place. CLIA requires that clinical
about them in this system of records ethnic-based community organizations, laboratories obtain a certificate from the
should address written inquiries to the and refugee community leaders. Secretary of Health and Human Services
System Manager. The request should (the Secretary), before accepting
EXEMPTIONS CLAIMED FOR THE SYSTEM:
include the alien number, age, materials derived from the human body
telephone number, and/or email address None. for laboratory tests (42 U.S.C. 263a(b)).
of the individual. The request must be [FR Doc. 2016–16812 Filed 7–15–16; 8:45 am] Laboratories that perform only tests that
signed by the individual to whom such BILLING CODE P are ‘‘simple’’ and that have an

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46694 Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Notices

‘‘insignificant risk of an erroneous MedicalDevices/ drawn from the flex studies; a
result’’ may obtain a certificate of DeviceRegulationandGuidance/ description of fail-safe and failure alert
waiver (42 U.S.C. 263a(d)(2)). The GuidanceDocuments/ucm079632.htm). mechanisms and a description of the
Secretary has delegated to FDA the This guidance document describes studies validating these mechanisms; a
authority to determine whether recommendations for device description of clinical tests that
particular tests (waived tests) are manufacturers submitting to FDA an demonstrate the accuracy of the test in
‘‘simple’’ and have ‘‘an insignificant risk application for determination that a the hands of intended operators; and
of an erroneous result’’ under CLIA (69 cleared or approved device meets this statistical analyses of clinical study
FR 22849, April 27, 2004). CLIA standard (CLIA waiver results.
On January 30, 2008, FDA published application). The guidance recommends In the Federal Register of April 1,
a guidance document entitled that CLIA waiver applications include a 2016 (81 FR 18858), FDA published a
‘‘Guidance for Industry and FDA Staff: description of the features of the device 60-day notice requesting public
Recommendations for Clinical that make it ‘‘simple’’; a report comment on the proposed collection of
Laboratory Improvement Amendments describing a hazard analysis that information. No comments were
of 1988 (CLIA) Waiver Applications for identifies potential sources of error, received.
Manufacturers of In Vitro Diagnostic including a summary of the design and FDA estimates the burden of this
Devices’’ (http://www.fda.gov/ results of flex studies and conclusions collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total operating
Number of Average
Number of Total annual and
Activity responses per burden per Total hours
respondents responses maintenance
respondent 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 specimen collection for study as well as Remanufacturing, and Servicing of
recordkeeping hours is 160,000 hours. shipping and supplies). Medical Devices Performed by Third-
FDA bases the burden on an Agency Dated: July 13, 2016. Party Entities and Original Equipment
analysis of premarket submissions with Leslie Kux,
Manufacturers.’’ The topics to be
clinical trials similar to the waived discussed are the current regulatory
Associate Commissioner for Policy.
laboratory tests. Based on previous environment for these activities, the
[FR Doc. 2016–16886 Filed 7–15–16; 8:45 am]
years’ experience with CLIA waiver definitions of the various terms FDA
BILLING CODE 4164–01–P proposed in the prior Federal Register
applications, FDA expects 40
manufacturers to submit one CLIA notice on this subject, and whether
waiver application per year. The time these activities should appropriately be
DEPARTMENT OF HEALTH AND
required to prepare and submit a waiver regulated by FDA or a non-
HUMAN SERVICES
application, including the time needed governmental organization.
to assemble supporting data, averages Food and Drug Administration DATES: The public workshop will be
1,200 hours per waiver application for held on October 27, 2016, from 8:30
[Docket No. FDA–2016–N–0001] a.m. to 5 p.m. and October 28, 2016,
a total of 48,000 hours for reporting.
Based on previous years’ experience from 8:30 a.m. to 4 p.m.
Refurbishing, Reconditioning,
with CLIA waiver applications, FDA ADDRESSES: The public workshop will
Rebuilding, Remarketing,
expects that each manufacturer will be held at FDA’s White Oak Campus,
Remanufacturing, and Servicing of
spend 2,800 hours creating and 10903 New Hampshire Ave., Bldg. 31
Medical Devices Performed by Third-
maintaining the record for a total of Conference Center, the Great Room (Rm.
Party Entities and Original Equipment
112,000 hours. 1503), Silver Spring, MD 20993–0002.
Manufacturers; Public Workshop
Entrance for the public workshop
The total operating and maintenance Food and Drug Administration, participants (non-FDA employees) is
asabaliauskas on DSK3SPTVN1PROD with NOTICES

AGENCY:
cost associated with the waiver HHS. through Building 1, where routine
application is estimated at $350,000. security check procedures will be
ACTION: Notice of public workshop.
This cost is largely attributed to clinical performed. For parking and security
study costs incurred, which include site SUMMARY: The Food and Drug information, please refer to http://
selection and qualification, protocol Administration (FDA) is announcing the www.fda.gov/AboutFDA/
review, and study execution (initiation, following public workshop entitled WorkingatFDA/BuildingsandFacilities/
monitoring, closeout, and clinical site/ ‘‘Refurbishing, Reconditioning, WhiteOakCampusInformation/
subject compensation—including Rebuilding, Remarketing, ucm241740.htm.

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Document Created: 2016-07-16 02:28:05
Document Modified: 2016-07-16 02:28:05

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		Fax written comments on the collection of information by August 17, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation		81 FR 46693

81 FR 46693 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 137 (July 18, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration