Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 56607-56609 [2017-25775]
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Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices
Ave., Bldg. 51, Rm. 6262, Silver Spring,
MD 20993, 301–796–3601.
NDA
020932 for ROXICODONE SR
(oxycodone HCl) Sustained-Release
Tablets, 10 mg and 30 mg, was received
on December 29, 1997, and approved on
October 26, 1998, as safe and effective
‘‘for the management of moderate to
severe pain where use of an opioid
analgesic is appropriate for more than a
few days’’ (see approval letter, available
at https://www.accessdata.fda.gov/
drugsatfda_docs/appletter/1998/
20932ltr.pdf). (FDA has verified the
Web site addresses as of the date this
document publishes in the Federal
Register, but Web sites are subject to
change over time.) FDA later
determined, however, that this
application had serious deficiencies.
Accordingly, on February 3, 2000, FDA
granted Roxane’s request for a stay of
the effective date of the approval of
NDA 020932 until such time as: (1)
Roxane submits additional data; (2) FDA
has reviewed those data; and (3) FDA
has determined that the submitted data
support a finding of safety and
effectiveness without reliance on
investigations to which Roxane does not
have a right of reference.1 Roxane has
not submitted any additional
information to support approval of NDA
020932, nor has it submitted any annual
reports for this NDA since 2002. The
product has never been marketed.2
Roxane requested that FDA withdraw
approval of NDA 020932 for
ROXICODONE (oxycodone HCl)
Sustained Release Tablets, and waived
the opportunity for a hearing concerning
this action.
For the reasons discussed above,
approval of NDA 020932, and all
amendments and supplements thereto,
is withdrawn. Distribution of
ROXICODONE (oxycodone HCl)
Sustained-Release Tablets, 10 mg and 30
mg, in interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the FD&C Act (21
U.S.C. 355(a) and 331(d)).
pmangrum on DSK3GDR082PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
1 February 3, 2000 FDA Response to Citizen
Petition and Petition for Stay of Action, Docket
FDA–1999–P–2921, available at https://
www.regulations.gov/document?D=FDA-1999-P2921-0014.
2 Reflecting their non-marketed status,
ROXICODONE (oxycodone HCl) Sustained-Release
Tablets, 10 mg and 30 mg, are on the ‘‘Discontinued
Drug Products’’ list in the Orange Book, where the
drug is listed as ‘‘Roxicodone’’ and described as
‘‘extended release’’ (see https://
www.accessdata.fda.gov/scripts/cder/ob/results_
product.cfm?Appl_Type=N&Appl_No=020932).
VerDate Sep<11>2014
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Dated: November 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–25771 Filed 11–28–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–5570]
Select Updates for Recommendations
for Clinical Laboratory Improvement
Amendments of 1988 Waiver
Applications for Manufacturers of In
Vitro Diagnostic Devices; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Select Updates for
Recommendations for Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) Waiver Applications for
Manufacturers of In Vitro Diagnostic
Devices.’’ FDA has developed this draft
guidance to implement a section of the
21st Century Cures Act (Cures Act) that
requires FDA to revise ‘‘V.
Demonstrating Insignificant Risk of an
Erroneous Result—Accuracy’’ of the
guidance ‘‘Recommendations for
Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver
Applications for Manufacturers of In
Vitro Diagnostic Devices’’ (‘‘2008 CLIA
Waiver Guidance’’) that was issued on
January 30, 2008. This draft guidance
updates FDA’s thinking regarding the
appropriate use of comparable
performance between a waived user and
a moderately complex laboratory user to
demonstrate accuracy. This draft
guidance is not final nor is it in effect
at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by January 29, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
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,
PO 00000
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56607
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–
2017–D–5570 for ‘‘Recommendations
for Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver
Applications for Manufacturers of In
Vitro Diagnostic Devices.’’ Received
comments 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
E:\FR\FM\29NON1.SGM
29NON1
pmangrum on DSK3GDR082PROD with NOTICES1
56608
Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices
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
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Recommendations
for Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver
Applications for Manufacturers of In
Vitro Diagnostic Devices’’ to the Office
of the Center Director, Guidance and
Policy Development, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Marina Kondratovich, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4672,
Silver Spring, MD 20993–0002, 301–
796–6036; or Peter Tobin, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5657,
Silver Spring, MD 20993–0002, 301–
796–6169.
SUPPLEMENTARY INFORMATION:
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15:19 Nov 28, 2017
Jkt 241001
I. Background
FDA has developed this draft
guidance to implement section 3057 of
the Cures Act (Pub. L. 114–255), which
requires FDA to revise ‘‘V.
Demonstrating Insignificant Risk of an
Erroneous Result—Accuracy’’ of the
guidance ‘‘Recommendations for
Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver
Applications for Manufacturers of In
Vitro Diagnostic Devices’’ (‘‘2008 CLIA
Waiver Guidance’’) that was issued on
January 30, 2008. This draft guidance
updates FDA’s thinking regarding the
appropriate use of comparable
performance between a waived user and
a moderately complex laboratory user to
demonstrate accuracy. The 2008 CLIA
Waiver Guidance remains in effect, in
its current form, until this draft
guidance is finalized, at which time the
updates in section III of this draft
guidance will supersede the
recommendations in section V of the
2008 CLIA Waiver Guidance.
FDA will incorporate the updates of
the final version of this draft guidance
into ‘‘V. Demonstrating Insignificant
Risk of an Erroneous Result—Accuracy’’
of the 2008 CLIA Waiver Guidance. The
remainder of the 2008 CLIA Waiver
Guidance will not be changed by this
update and will remain in effect.
The Secretary of Health and Human
Services has delegated to FDA the
authority to determine whether
particular tests are ‘‘simple’’ and have
‘‘an insignificant risk of an erroneous
result’’ under CLIA and are thus eligible
for waiver categorization (69 FR 22849,
April 27, 2004). The Centers for
Medicare & Medicaid Services (CMS) is
responsible for oversight of clinical
laboratories, which includes issuing
Certificates of Waiver. CLIA requires
that clinical laboratories obtain a
certificate 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)).
CLIA, 42 U.S.C. 263a(d)(3)
Examinations and Procedures, as
modified by the Food and Drug
Administration Modernization Act of
1997 (FDAMA), reads as follows
regarding tests that may be performed
by laboratories with a Certificate of
Waiver:
‘‘The examinations and procedures [that
may be performed by a laboratory with a
Certificate of Waiver] . . . are laboratory
examinations and procedures that have been
approved by the Food and Drug
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Frm 00029
Fmt 4703
Sfmt 4703
Administration for home use or that, as
determined by the Secretary, are simple
laboratory examinations and procedures that
have an insignificant risk of an erroneous
result, including those that—(A) employ
methodologies that are so simple and
accurate as to render the likelihood of
erroneous results by the user negligible, or
(B) the Secretary has determined pose no
unreasonable risk of harm to the patient if
performed incorrectly.’’
The 2008 CLIA Waiver Guidance
describes recommendations for device
manufacturers about study design and
analysis for CLIA Waiver by Application
to support an FDA determination as to
whether the device meets the statutory
criteria for waiver described above. This
update provides additional details and
pathways for demonstrating that a test
has an insignificant risk of erroneous
result which is a key element for
obtaining a CLIA Waiver by
Application.
In developing this specific update, we
have considered interactions with
stakeholders since the issuance of the
final guidance on January 30, 2008.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Recommendations for Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) Waiver Applications for
Manufacturers of in Vitro Diagnostic
Devices.’’ It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This draft guidance is
not subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Recommendations for Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) Waiver Applications for
Manufacturers of In Vitro Diagnostic
Devices’’ may send an email request to
CDRH-Guidance@fda.hhs.gov to receive
an electronic copy of the document.
Please use the document number
GUD1627 to identify the guidance you
are requesting.
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Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
The collections of information in this
guidance were approved under OMB
control number 0910–0598. The
collections of information in 21 CFR
part 54 have been approved under
0910–0396, and the collections of
information in 21 CFR parts 50 and 56
have been approved under OMB control
number 0910–0755.
Dated: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–25775 Filed 11–28–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–2216]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; VELTASSA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for VELTASSA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by January 29, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
May 29, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
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 January 29,
2018. The https://www.regulations.gov
pmangrum on DSK3GDR082PROD with NOTICES1
DATES:
VerDate Sep<11>2014
15:19 Nov 28, 2017
Jkt 241001
electronic filing system will accept
comments until midnight Eastern Time
at the end of January 29, 2018.
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–
2016–E–2216 for ’’Determination of
Regulatory Review Period for Purposes
of Patent Extension; VELTASSA.’’
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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
56609
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
except in accordance with § 10.20 (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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
E:\FR\FM\29NON1.SGM
29NON1
Agencies
[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56607-56609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25775]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-5570]
Select Updates for Recommendations for Clinical Laboratory
Improvement Amendments of 1988 Waiver Applications for Manufacturers of
In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Select Updates for
Recommendations for Clinical Laboratory Improvement Amendments of 1988
(CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic
Devices.'' FDA has developed this draft guidance to implement a section
of the 21st Century Cures Act (Cures Act) that requires FDA to revise
``V. Demonstrating Insignificant Risk of an Erroneous Result--
Accuracy'' of the guidance ``Recommendations for Clinical Laboratory
Improvement Amendments of 1988 (CLIA) Waiver Applications for
Manufacturers of In Vitro Diagnostic Devices'' (``2008 CLIA Waiver
Guidance'') that was issued on January 30, 2008. This draft guidance
updates FDA's thinking regarding the appropriate use of comparable
performance between a waived user and a moderately complex laboratory
user to demonstrate accuracy. This draft guidance is not final nor is
it in effect at this time.
DATES: Submit either electronic or written comments on the draft
guidance by January 29, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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-2017-D-5570 for ``Recommendations for Clinical Laboratory
Improvement Amendments of 1988 (CLIA) Waiver Applications for
Manufacturers of In Vitro Diagnostic Devices.'' Received comments 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
[[Page 56608]]
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 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.gpo.gov/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Recommendations for Clinical Laboratory Improvement Amendments of
1988 (CLIA) Waiver Applications for Manufacturers of In Vitro
Diagnostic Devices'' to the Office of the Center Director, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT: Marina Kondratovich, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4672, Silver Spring, MD 20993-0002,
301-796-6036; or Peter Tobin, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5657, Silver Spring, MD 20993-0002, 301-796-6169.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has developed this draft guidance to implement section 3057 of
the Cures Act (Pub. L. 114-255), which requires FDA to revise ``V.
Demonstrating Insignificant Risk of an Erroneous Result--Accuracy'' of
the guidance ``Recommendations for Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In
Vitro Diagnostic Devices'' (``2008 CLIA Waiver Guidance'') that was
issued on January 30, 2008. This draft guidance updates FDA's thinking
regarding the appropriate use of comparable performance between a
waived user and a moderately complex laboratory user to demonstrate
accuracy. The 2008 CLIA Waiver Guidance remains in effect, in its
current form, until this draft guidance is finalized, at which time the
updates in section III of this draft guidance will supersede the
recommendations in section V of the 2008 CLIA Waiver Guidance.
FDA will incorporate the updates of the final version of this draft
guidance into ``V. Demonstrating Insignificant Risk of an Erroneous
Result--Accuracy'' of the 2008 CLIA Waiver Guidance. The remainder of
the 2008 CLIA Waiver Guidance will not be changed by this update and
will remain in effect.
The Secretary of Health and Human Services has delegated to FDA the
authority to determine whether particular tests are ``simple'' and have
``an insignificant risk of an erroneous result'' under CLIA and are
thus eligible for waiver categorization (69 FR 22849, April 27, 2004).
The Centers for Medicare & Medicaid Services (CMS) is responsible for
oversight of clinical laboratories, which includes issuing Certificates
of Waiver. CLIA requires that clinical laboratories obtain a
certificate 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)).
CLIA, 42 U.S.C. 263a(d)(3) Examinations and Procedures, as modified
by the Food and Drug Administration Modernization Act of 1997 (FDAMA),
reads as follows regarding tests that may be performed by laboratories
with a Certificate of Waiver:
``The examinations and procedures [that may be performed by a
laboratory with a Certificate of Waiver] . . . are laboratory
examinations and procedures that have been approved by the Food and
Drug Administration for home use or that, as determined by the
Secretary, are simple laboratory examinations and procedures that
have an insignificant risk of an erroneous result, including those
that--(A) employ methodologies that are so simple and accurate as to
render the likelihood of erroneous results by the user negligible,
or (B) the Secretary has determined pose no unreasonable risk of
harm to the patient if performed incorrectly.''
The 2008 CLIA Waiver Guidance describes recommendations for device
manufacturers about study design and analysis for CLIA Waiver by
Application to support an FDA determination as to whether the device
meets the statutory criteria for waiver described above. This update
provides additional details and pathways for demonstrating that a test
has an insignificant risk of erroneous result which is a key element
for obtaining a CLIA Waiver by Application.
In developing this specific update, we have considered interactions
with stakeholders since the issuance of the final guidance on January
30, 2008.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Recommendations for Clinical Laboratory Improvement Amendments of
1988 (CLIA) Waiver Applications for Manufacturers of in Vitro
Diagnostic Devices.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations. This draft guidance is not subject to Executive Order
12866.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``Recommendations for Clinical
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications
for Manufacturers of In Vitro Diagnostic Devices'' may send an email
request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of
the document. Please use the document number GUD1627 to identify the
guidance you are requesting.
[[Page 56609]]
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. The collections of information in
this guidance were approved under OMB control number 0910-0598. The
collections of information in 21 CFR part 54 have been approved under
0910-0396, and the collections of information in 21 CFR parts 50 and 56
have been approved under OMB control number 0910-0755.
Dated: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25775 Filed 11-28-17; 8:45 am]
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