Clinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal Occult Blood (FOB) Testing, 48770-48773 [2017-22813]
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Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Rules and Regulations
C. Paperwork Reduction Act (PRA)
This action does not impose an
information collection burden under the
provisions of the Paperwork Reduction
Act, 44 U.S.C. 3501 et seq.
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA. This action will not
impose any requirements on small
entities.
E. Unfunded Mandates Reform Act
(UMRA)
This action does not contain an
unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C.
1531–1538, and does not significantly or
uniquely affect small governments.
F. Executive Order 13132: Federalism
This action does not have federalism
implications. It will not have substantial
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relationship between the national
government and the states, or on the
distribution of power and
responsibilities among the various
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nlaroche on DSK9F9SC42PROD with RULES
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Governments
This action does not have tribal
implications, as specified in Executive
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direct effects on any Indian tribes, on
the relationship between the federal
government and Indian tribes, or on the
distribution of power and
responsibilities between the federal
government and Indian tribes. Thus,
Executive Order 13175 does not apply
to this action.
H. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
The EPA interprets Executive Order
13045 as applying only to those
regulatory actions that concern health or
safety risks that the EPA has reason to
believe may disproportionately affect
children, per the definition of ‘‘covered
regulatory action’’ in section 2–202 of
the Executive Order. This action is not
subject to Executive Order 13045
because it merely rescinds a FIP
covering a generating station that has
been decommissioned and demolished.
I. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211 because it is not a
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significant regulatory action under
Executive Order 12866.
shall not postpone the effectiveness of
such rule or action.
J. National Technology Transfer and
Advancement Act
List of Subjects in 40 CFR Part 52
This rulemaking does not involve
technical standards. The EPA is not
revising any technical standards or
imposing any new technical standards
in this action.
K. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
The EPA believes that this action does
not have disproportionately high and
adverse human health or environmental
effects on minority populations, lowincome populations, and/or indigenous
peoples, as specified in Executive Order
12898 (59 FR 7629, February 16, 1994).
The documentation for this decision is
contained in section III above.
L. Determination Under Section 307(d)
Pursuant to CAA section 307(d)(1)(B),
the EPA has determined that this action
is subject to the provisions of section
307(d). Section 307(d) establishes
procedural requirements specific to
certain rulemaking actions under the
CAA. Pursuant to CAA section
307(d)(1)(B), the rescission of the MGS
FIP is subject to the requirements of
CAA section 307(d), as it constitutes a
revision to a FIP under CAA section
110(c). Furthermore, CAA section
307(d)(1)(V) provides that the
provisions of section 307(d) apply to
‘‘such other actions as the Administrator
may determine.’’ The EPA determines
that the provisions of 307(d) apply to
the EPA’s action on the MGS FIP
rescission.
M. Congressional Review Act (CRA)
This rule is exempt from the CRA
because it is a rule of particular
applicability. The EPA is not required to
submit a rule report regarding this
action under section 801 because this is
a rule of particular applicability that
only applies to a single,
decommissioned facility.
N. Petitions for Judicial Review
Under CAA section 307(b)(1),
petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the appropriate
circuit by December 19, 2017. Filing a
petition for reconsideration by the
Administrator of this final rule does not
affect the finality of this rule for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
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Environmental protection, Air
pollution control, Incorporation by
reference, Sulfur oxides.
Authority: 42 U.S.C. 7401 et seq.
Dated: October 13, 2017.
E. Scott Pruitt,
Administrator, EPA.
For the reasons set forth in the
preamble, EPA amends 40 CFR part 52
as follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401, et seq.
Subpart DD—Nevada
§ 52.1488
[Amended]
2. Section 52.1488 is amended by
removing and reserving paragraph (d).
■
[FR Doc. 2017–22701 Filed 10–19–17; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 493
[CMS–3271–F]
RIN 0938–AS04
Clinical Laboratory Improvement
Amendments of 1988 (CLIA); Fecal
Occult Blood (FOB) Testing
Centers for Medicare &
Medicaid Services (CMS), HHS; Centers
for Disease Control and Prevention
(CDC), HHS.
ACTION: Final rule.
AGENCY:
This final rule amends the
Clinical Laboratory Improvement
Amendments of 1988 (CLIA) regulations
to clarify that the waived test
categorization applies only to nonautomated fecal occult blood tests.
DATES: These regulations are effective
December 19, 2017.
FOR FURTHER INFORMATION CONTACT:
Nancy Anderson, CDC, (404) 498–2280,
or Daralyn Hassan, CMS, (410) 786–
9360.
SUMMARY:
SUPPLEMENTARY INFORMATION:
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I. Background
The Clinical Laboratory Improvement
Amendments of 1988 (CLIA) (section
353 of the Public Health Service Act,
codified at 42 U.S.C. 263a) requires any
facility performing examinations of
human specimens (for example, tissue,
blood, and urine) for diagnosis,
prevention, or treatment purposes to be
certified by the Secretary of the
Department of Health and Human
Services (HHS). The objective of the
CLIA program is to ensure accurate and
reliable laboratory testing. The Centers
for Medicare & Medicaid Services (CMS)
is responsible for the administration of
CLIA. The Centers for Disease Control
and Prevention (CDC) provides
scientific and technical support/
consultation to HHS and CMS. The
Food and Drug Administration (FDA) is
responsible for test categorization.
To receive a certificate of waiver
(COW) under CLIA, a laboratory must
only perform tests listed as waived in
the CLIA regulations at 42 CFR
493.15(c) (for example, urine pregnancy
tests—visual color comparison tests) or
tests which the FDA has determined to
be waived because they are simple with
an insignificant risk of error. Waived
tests are exempt from most CLIA
requirements, and the laboratories that
perform them receive no routine
surveys.
Waived laboratories must meet only
the following requirements under CLIA:
• Enroll in the CLIA program;
• Pay applicable certificate fees
biennially; and
• Follow manufacturers’ test
instructions.
Since the implementation of the CLIA
program in 1992, the types of tests
waived under CLIA have increased from
8 to currently 97; consequently, the
percentage of laboratories issued a COW
has grown significantly from 20 percent
to almost 72 percent of the approximate
250,000 laboratories enrolled.
Dipstick or tablet reagent urinalysis
(non-automated) and fecal occult blood
(FOB) are two of the original 8 waived
tests published in the Federal Register
in 1992, as specified at § 493.15(c)(1)
and (2), respectively. The regulation
specifies that waived test status is
applicable to ‘‘non-automated’’ dipstick
or tablet reagent urinalysis, but it does
not specify ‘‘non-automated’’ for FOB
tests. At the time the regulation was
adopted, the FOB test was only
available as a manual or non-automated
test. However, there are now automated
FOB analyzers that use complex and
sophisticated technology, which do not
meet the CLIA criteria for waiver and,
therefore, should not be waived. It was
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therefore necessary to propose
amendments to the regulations to
exclude these automated tests from the
list of waived tests in the CLIA
regulations.
Furthermore, since the development
and proliferation of the waived test for
hemoglobin by single analyte
instruments with self-contained or
component features, as described at
§ 493.15(c)(9), it was our understanding
that the non-automated hemoglobin by
copper sulfate method at § 493.15(c)(6)
was no longer in use. Therefore, we
proposed to remove the hemoglobin by
copper sulfate method from the list of
waived tests at § 493.15(c)(6) if
commenters confirmed that the method
is no longer used.
II. Provisions of the Proposed
Regulations
On November 7, 2014, we published
a proposed rule in the Federal Register
(79 FR 66348 through 66350) entitled,
‘‘Clinical Laboratory Improvement
Amendments (CLIA); Fecal Occult
Blood (FOB) Testing.’’ In that rule, we
proposed to revise § 493.15(c)(2) by
adding the words ‘‘non-automated’’
following ‘‘Fecal occult blood.’’ This
change would exclude the more
complex automated FOB analyzers from
the list of waived tests in the CLIA
regulations.
In addition, we proposed to remove
the hemoglobin by copper sulfate
method from the list of waived tests at
§ 493.15(c)(6) if we received public
comments confirming that this method
is no longer used.
Finally, we proposed to renumber the
remaining paragraphs if § 493.15(c)(6)
was removed.
III. Analysis of and Responses to Public
Comments
In response to the November 7, 2014
proposed rule, we received 7 public
comments. Interested parties that
submitted comments included blood
donor centers, laboratories and
accreditation organizations. A summary
of the comments and our responses are
as follows:
Comment: One commenter supported
our proposal to add the words ‘‘nonautomated’’ following ‘‘Fecal occult
blood.’’
Response: We appreciate the
commenters’ support. This change
would exclude the more complex
automated FOB analyzers from the list
of waived tests in the CLIA regulations.
Comment: In regard to our proposal to
remove the hemoglobin by copper
sulfate method from the list of waived
tests if comments confirmed that this
method is no longer used, one
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48771
commenter stated that they collect
approximately 10,000 units of blood per
year and currently use the hemoglobin
by copper sulfate method for cost
reasons. Another commenter stated that
they use the hemoglobin by copper
sulfate method as a qualitative method
to detect hemoglobin levels of 12.5g/dl
or greater.
Several commenters indicated that
they use the hemoglobin by copper
sulfate method to screen donors for
acceptable pre-donation hemoglobin.
Specifically, they perform
approximately 20,000 to 30,000 tests per
year.
Response: In consideration of these
public comments, which indicate that
the hemoglobin by copper sulfate
method is still in use, we are not
finalizing our proposal to remove the
hemoglobin by copper sulfate method
from the list of waived tests at
§ 493.15(c)(6).
Comment: One commenter stated that
it is appropriate to require ‘‘automated
FOB tests’’ to be evaluated through the
CLIA waiver process instead of
automatically waiving these devices.
However, the commenter believed that
‘‘waived testing’’ poses risk to patients
in certain settings and that any test that
may result in harm should not be
waived.
Response: We appreciate the
commenter’s support for requiring
‘‘automated FOB tests’’ to be evaluated
through the CLIA waiver process
instead of automatically waiving these
devices. According to section 263a(d)(3)
of the CLIA statute, waived tests are
simple laboratory examinations and
procedures that have been approved by
the FDA 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
employ methodologies that are so
simple and accurate that the likelihood
of inaccurate result by the user is
negligible, and those that the Secretary
has determined pose no unreasonable
risk of harm to the patient if performed
incorrectly. Therefore, we believe that
waived tests that are determined to have
met the statutory criteria do not pose a
significant risk of harm to patients.
IV. Provisions of the Final Regulations
We are adopting as final the provision
set forth in the November 7, 2014
proposed rule (79 FR 66348 through
66350) with the following
modifications:
• In consideration of public
comments, we are not finalizing our
proposal to remove the hemoglobin by
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copper sulfate method from the list of
waived tests at § 493.15(c)(6).
• Since we are not removing
§ 493.15(c)(6), we are not finalizing our
proposal to renumber the remaining
paragraphs in this section.
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V. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
VI. Regulatory Impact Statement
We have examined the impact of this
rule as required by Executive Order
12866 on Regulatory Planning and
Review (September 30, 1993), Executive
Order 13563 on Improving Regulation
and Regulatory Review (January 18,
2011), the Regulatory Flexibility Act
(RFA) (September 19, 1980, Pub. L. 96–
354), section 1102(b) of the Social
Security Act, section 202 of the
Unfunded Mandates Reform Act of 1995
(March 22, 1995; Pub. L. 104–4),
Executive Order 13132 on Federalism
(August 4, 1999), the Congressional
Review Act (5 U.S.C. 804(2)), and
Executive Order 13771 on Reducing
Regulation and Controlling Regulatory
Costs (January 30, 2017).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). A regulatory impact analysis
must be prepared for major rules with
economically significant effects ($100
million or more in any 1 year). This rule
does not reach the economic threshold
and thus is not considered a major rule.
This final rule amends the CLIA
regulations at § 493.15(c)(2) to provide
that only non-automated FOB tests are
waived by the regulation. Automated
test systems that detect FOB would,
therefore, be subject to test
categorization by the FDA as moderate
or high complexity as described in
§ 493.17. These test systems would only
be considered for waiver approval if the
manufacturer submits a waiver
application to the FDA demonstrating
the particular test system meets the
statutory waiver criteria of being simple
and having an insignificant risk of an
erroneous result.
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As of July 11, 2017, the FDA CLIA test
categorization database includes 134
FOB test systems. Five of these test
systems are automated and are
categorized by the FDA as moderate
(non-waived) complexity; all others are
waived non-automated methods (https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfCLIA/search.cfm). Only two of
the five automated test systems are sold
in the United States. Because the
current regulation governing FOB tests
does not specify automated or nonautomated FOB tests, it could be
misconstrued that automated FOB test
systems are available for use by
laboratories with a COW. As amended,
it will be clear that automated FOB test
systems are not permitted for use by a
laboratory with a COW under
§ 493.15(c)(2). This means that testing
sites using one or both of the two
automated test systems noted above
(which are categorized as moderate
complexity tests) would be impacted by
this rule if they are currently operating
under a COW. According to the
information on automated analyzers for
FOB testing distributed in the United
States provided by manufacturers, we
estimate that no more than 26
laboratories would be impacted by this
regulatory change. We developed a
range of the estimated economic impact
for changes that may result from this
final rule. Our highest estimate totals
approximately $151,000 for the first
year, due to the initial costs required to
change certificate types for all
potentially impacted laboratories. This
would decrease in years two through
five, projected to be as low as
approximately $3,000 per year in years
two and four, when no certificate fees
would be paid. Therefore, this rule does
not meet the economic threshold to be
considered a major rule.
The RFA requires agencies to analyze
options for regulatory relief of small
entities. For purposes of the RFA, small
entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions. Most
hospitals and most other providers and
suppliers are small entities, either by
nonprofit status or by having revenues
of less than $7.5 million to $38.5
million in any 1 year. Individuals and
states are not included in the definition
of a small entity. We are not preparing
an analysis for the RFA because we
believe that approximately 79 percent of
United States medical laboratories
qualify as small entities based on their
nonprofit status as reported in the
American Hospital Association Fast
Fact Sheet, updated July 11, 2017
(https://www.aha.org/research/rc/stat-
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studies/fast-facts.shtml). However, as
previously described, due to the low
number of automated analyzers
distributed in the United States, we
estimate that no more than 26
laboratories would potentially be
impacted by this regulatory change. As
its measure of significant economic
impact on a substantial number of small
entities, HHS uses a change in revenue
of more than 3 to 5 percent. We do not
believe that this threshold would be
reached by the requirements in this final
rule because very few small entities
would be subject to the provisions in
this rule.
In addition, section 1102(b) of the
Social Security Act (the Act) requires us
to prepare a regulatory impact analysis
if a rule may have a significant impact
on the operations of a substantial
number of small rural hospitals. This
analysis must conform to the provisions
of section 604 of the RFA. For purposes
of section 1102(b) of the Act, we define
a small rural hospital as a hospital that
is located outside of a Metropolitan
Statistical Area for Medicare payment
regulations and has fewer than 100
beds. We do not expect this final rule
to have a significant impact on a
substantial number of small rural
hospitals. The changes in this final rule
would apply only to the laboratories
previously described, which do not
include any small rural hospitals at this
time. Thus, an analysis under section
1102(b) of the Act is not required for
this rulemaking.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates require spending
in any 1 year of $100 million in 1995
dollars, updated annually for inflation.
In 2017, that threshold is approximately
$148 million. This rule will have no
consequential effect on state, local, or
tribal governments or on the private
sector.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on state and local
governments, preempts state law, or
otherwise has Federalism implications.
Since this regulation does not impose
any costs on state or local governments,
the requirements of Executive Order
13132 are not applicable.
Executive Order 13771, entitled
‘‘Reducing Regulation and Controlling
Regulatory Costs,’’ was issued on
January 30, 2017 (82 FR 9339, February
3, 2017). Section 2(a) of Executive Order
13771 requires an agency, unless
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prohibited by law, to identify at least
two existing regulations to be repealed
when the agency publicly proposes for
notice and comment, or otherwise
promulgates, a new regulation. In
furtherance of this requirement, section
2(c) of Executive Order 13771 requires
that the new incremental costs
associated with new regulations shall, to
the extent permitted by law, be offset by
the elimination of existing costs
associated with at least two prior
regulations. OMB’s interim guidance,
issued on April 5, 2017, https://
www.whitehouse.gov/the-press-office/
2017/04/05/memorandumimplementing-executive-order-13771titled-reducing-regulation, explains that
for Fiscal Year 2017 the above
requirements only apply to each new
‘‘significant regulatory action that
imposes costs.’’ It has been determined
that this final rule is not a ‘‘significant
regulatory action thus does not trigger
the above requirements of Executive
Order 13771.
Dated: August 24, 2017.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
List of Subjects in 42 CFR Part 493
AGENCY:
Administrative practice and
procedure, Grant programs—health,
Health facilities, Laboratories, Medicaid,
Medicare, Penalties, Reporting and
recordkeeping requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR part
493 as set forth below:
PART 493—LABORATORY
REQUIREMENTS
1. The authority citation for part 493
continues to read as follows:
■
Authority: Sec. 353 of the Public Health
Service Act, secs. 1102, 1861(e), the sentence
following sections 1861(s)(11) through
1861(s)(16) of the Social Security Act (42
U.S.C. 263a, 1302, 1395x(e), the sentence
following 1395x(s)(11) through 1395x(s)(16)),
and the Pub. L. 112–202 amendments to 42
U.S.C. 263a.
2. Section 493.15 is amended by
revising paragraph (c)(2) to read as
follows:
■
§ 493.15
tests.
Laboratories performing waived
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*
*
*
*
*
(c) * * *
(2) Fecal occult blood-non-automated;
*
*
*
*
*
Dated: October 5, 2017.
Anne Schuchat,
RADM, U.S. Public Health Service, Principal
Deputy Director, Centers for Disease Control
and Prevention.
Dated: October 12, 2017.
Eric D. Hargan,
Acting Secretary, Department of Health and
Human Services.
[FR Doc. 2017–22813 Filed 10–19–17; 8:45 am]
BILLING CODE 4120–01–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Parts 1 and 20
[GN Docket No. 13–111; FCC 17–25]
Promoting Technological Solutions to
Combat Contraband Wireless Devices
in Correctional Facilities
Federal Communications
Commission.
ACTION: Final rule; announcement of
effective date.
In this document, the Federal
Communications Commission
(Commission) announces that the Office
of Management and Budget (OMB) has
approved, for a period of three years, the
information collection associated with
the Commission’s Report and Order,
FCC 17–25. This document is consistent
with the Report and Order, which stated
that the Commission would publish a
document in the Federal Register
announcing OMB approval of the
information collection requirement and
the relevant effective date of the rules.
DATES: The rule amendments to 47 CFR
1.9020(n), 1.9030(m), 1.9035(o), and
20.23(a), published at 82 FR 22742, May
18, 2017, which required OMB
approval, are effective on October 20,
2017. The rule amendments to (1) 47
CFR 1.9020(d)(8), 1.9030(d)(8),
1.9035(d)(4), and 20.18(a), which did
not require OMB approval; and (2) 47
CFR 20.18(r), which required OMB
approval, published at 82 FR 22742,
May 18, 2017, are effective on February
12, 2018.
FOR FURTHER INFORMATION CONTACT: For
additional information, contact Cathy
Williams by email at Cathy.Williams@
fcc.gov and telephone at (202) 418–
2918.
SUMMARY:
This
document announces that, on October 2,
2017, OMB approved the information
SUPPLEMENTARY INFORMATION:
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48773
collection requirement contained in the
Commission’s Report and Order, FCC
17–25, published at 82 FR 22742, May
18, 2017. The OMB Control Number is
3060–1243. The Commission publishes
this document as an announcement of
the effective dates of the rules. Note that
the rules effective on February 12, 2018,
as listed above, are effective on that date
pursuant to the Report and Order,
paragraph 142, the date 270 days after
publication of the text or a summary
thereof in the Federal Register. If you
have any comments on the burden
estimates listed below, or how the
Commission can improve the collection
and reduce any burdens caused thereby,
please contact Cathy Williams, Federal
Communications Commission, Room 1–
C823, 445 12th Street SW., Washington,
DC 20554. Please include the OMB
Control Number 3060–1243 in your
correspondence. The Commission will
also accept your comments via email at
PRA@fcc.gov.
To request materials in accessible
formats for people with disabilities
(Braille, large print, electronic files,
audio format), send an email to fcc504@
fcc.gov or call the Consumer and
Governmental Affairs Bureau at (202)
418–0530 (voice), (202) 418–0432
(TTY).
Synopsis
As required by the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507),
the Commission is notifying the public
that it received final OMB approval on
October 2, 2017, for the information
collection requirement contained in 47
CFR 1.9020(n), 1.9030(m), 1.9035(o),
20.18, and 20.23(a), as amended in the
Commission’s Report and Order, FCC
17–25.
Under 5 CFR part 1320, an agency
may not conduct or sponsor a collection
of information unless it displays a
current, valid OMB Control Number. No
person shall be subject to any penalty
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of information subject to the Paperwork
Reduction Act that does not display a
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The OMB Control Number is 3060–
1243.
The foregoing notice is required by
the Paperwork Reduction Act of 1995,
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and 44 U.S.C. 3507. The total annual
reporting burdens and costs for the
respondents are as follows:
OMB Control Number: 3060–1243.
OMB Approval Date: October 2, 2017.
OMB Expiration Date: October 31,
2020.
Title: Sections 1.9020(n), 1.9030(m),
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requirement for certain contraband
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Agencies
[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Rules and Regulations]
[Pages 48770-48773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22813]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 493
[CMS-3271-F]
RIN 0938-AS04
Clinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal
Occult Blood (FOB) Testing
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS; Centers
for Disease Control and Prevention (CDC), HHS.
ACTION: Final rule.
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SUMMARY: This final rule amends the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) regulations to clarify that the waived test
categorization applies only to non-automated fecal occult blood tests.
DATES: These regulations are effective December 19, 2017.
FOR FURTHER INFORMATION CONTACT: Nancy Anderson, CDC, (404) 498-2280,
or Daralyn Hassan, CMS, (410) 786-9360.
SUPPLEMENTARY INFORMATION:
[[Page 48771]]
I. Background
The Clinical Laboratory Improvement Amendments of 1988 (CLIA)
(section 353 of the Public Health Service Act, codified at 42 U.S.C.
263a) requires any facility performing examinations of human specimens
(for example, tissue, blood, and urine) for diagnosis, prevention, or
treatment purposes to be certified by the Secretary of the Department
of Health and Human Services (HHS). The objective of the CLIA program
is to ensure accurate and reliable laboratory testing. The Centers for
Medicare & Medicaid Services (CMS) is responsible for the
administration of CLIA. The Centers for Disease Control and Prevention
(CDC) provides scientific and technical support/consultation to HHS and
CMS. The Food and Drug Administration (FDA) is responsible for test
categorization.
To receive a certificate of waiver (COW) under CLIA, a laboratory
must only perform tests listed as waived in the CLIA regulations at 42
CFR 493.15(c) (for example, urine pregnancy tests--visual color
comparison tests) or tests which the FDA has determined to be waived
because they are simple with an insignificant risk of error. Waived
tests are exempt from most CLIA requirements, and the laboratories that
perform them receive no routine surveys.
Waived laboratories must meet only the following requirements under
CLIA:
Enroll in the CLIA program;
Pay applicable certificate fees biennially; and
Follow manufacturers' test instructions.
Since the implementation of the CLIA program in 1992, the types of
tests waived under CLIA have increased from 8 to currently 97;
consequently, the percentage of laboratories issued a COW has grown
significantly from 20 percent to almost 72 percent of the approximate
250,000 laboratories enrolled.
Dipstick or tablet reagent urinalysis (non-automated) and fecal
occult blood (FOB) are two of the original 8 waived tests published in
the Federal Register in 1992, as specified at Sec. 493.15(c)(1) and
(2), respectively. The regulation specifies that waived test status is
applicable to ``non-automated'' dipstick or tablet reagent urinalysis,
but it does not specify ``non-automated'' for FOB tests. At the time
the regulation was adopted, the FOB test was only available as a manual
or non-automated test. However, there are now automated FOB analyzers
that use complex and sophisticated technology, which do not meet the
CLIA criteria for waiver and, therefore, should not be waived. It was
therefore necessary to propose amendments to the regulations to exclude
these automated tests from the list of waived tests in the CLIA
regulations.
Furthermore, since the development and proliferation of the waived
test for hemoglobin by single analyte instruments with self-contained
or component features, as described at Sec. 493.15(c)(9), it was our
understanding that the non-automated hemoglobin by copper sulfate
method at Sec. 493.15(c)(6) was no longer in use. Therefore, we
proposed to remove the hemoglobin by copper sulfate method from the
list of waived tests at Sec. 493.15(c)(6) if commenters confirmed that
the method is no longer used.
II. Provisions of the Proposed Regulations
On November 7, 2014, we published a proposed rule in the Federal
Register (79 FR 66348 through 66350) entitled, ``Clinical Laboratory
Improvement Amendments (CLIA); Fecal Occult Blood (FOB) Testing.'' In
that rule, we proposed to revise Sec. 493.15(c)(2) by adding the words
``non-automated'' following ``Fecal occult blood.'' This change would
exclude the more complex automated FOB analyzers from the list of
waived tests in the CLIA regulations.
In addition, we proposed to remove the hemoglobin by copper sulfate
method from the list of waived tests at Sec. 493.15(c)(6) if we
received public comments confirming that this method is no longer used.
Finally, we proposed to renumber the remaining paragraphs if Sec.
493.15(c)(6) was removed.
III. Analysis of and Responses to Public Comments
In response to the November 7, 2014 proposed rule, we received 7
public comments. Interested parties that submitted comments included
blood donor centers, laboratories and accreditation organizations. A
summary of the comments and our responses are as follows:
Comment: One commenter supported our proposal to add the words
``non-automated'' following ``Fecal occult blood.''
Response: We appreciate the commenters' support. This change would
exclude the more complex automated FOB analyzers from the list of
waived tests in the CLIA regulations.
Comment: In regard to our proposal to remove the hemoglobin by
copper sulfate method from the list of waived tests if comments
confirmed that this method is no longer used, one commenter stated that
they collect approximately 10,000 units of blood per year and currently
use the hemoglobin by copper sulfate method for cost reasons. Another
commenter stated that they use the hemoglobin by copper sulfate method
as a qualitative method to detect hemoglobin levels of 12.5g/dl or
greater.
Several commenters indicated that they use the hemoglobin by copper
sulfate method to screen donors for acceptable pre-donation hemoglobin.
Specifically, they perform approximately 20,000 to 30,000 tests per
year.
Response: In consideration of these public comments, which indicate
that the hemoglobin by copper sulfate method is still in use, we are
not finalizing our proposal to remove the hemoglobin by copper sulfate
method from the list of waived tests at Sec. 493.15(c)(6).
Comment: One commenter stated that it is appropriate to require
``automated FOB tests'' to be evaluated through the CLIA waiver process
instead of automatically waiving these devices. However, the commenter
believed that ``waived testing'' poses risk to patients in certain
settings and that any test that may result in harm should not be
waived.
Response: We appreciate the commenter's support for requiring
``automated FOB tests'' to be evaluated through the CLIA waiver process
instead of automatically waiving these devices. According to section
263a(d)(3) of the CLIA statute, waived tests are simple laboratory
examinations and procedures that have been approved by the FDA 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 employ methodologies that are so
simple and accurate that the likelihood of inaccurate result by the
user is negligible, and those that the Secretary has determined pose no
unreasonable risk of harm to the patient if performed incorrectly.
Therefore, we believe that waived tests that are determined to have met
the statutory criteria do not pose a significant risk of harm to
patients.
IV. Provisions of the Final Regulations
We are adopting as final the provision set forth in the November 7,
2014 proposed rule (79 FR 66348 through 66350) with the following
modifications:
In consideration of public comments, we are not finalizing
our proposal to remove the hemoglobin by
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copper sulfate method from the list of waived tests at Sec.
493.15(c)(6).
Since we are not removing Sec. 493.15(c)(6), we are not
finalizing our proposal to renumber the remaining paragraphs in this
section.
V. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
VI. Regulatory Impact Statement
We have examined the impact of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22,
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4,
1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive
Order 13771 on Reducing Regulation and Controlling Regulatory Costs
(January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
This rule does not reach the economic threshold and thus is not
considered a major rule.
This final rule amends the CLIA regulations at Sec. 493.15(c)(2)
to provide that only non-automated FOB tests are waived by the
regulation. Automated test systems that detect FOB would, therefore, be
subject to test categorization by the FDA as moderate or high
complexity as described in Sec. 493.17. These test systems would only
be considered for waiver approval if the manufacturer submits a waiver
application to the FDA demonstrating the particular test system meets
the statutory waiver criteria of being simple and having an
insignificant risk of an erroneous result.
As of July 11, 2017, the FDA CLIA test categorization database
includes 134 FOB test systems. Five of these test systems are automated
and are categorized by the FDA as moderate (non-waived) complexity; all
others are waived non-automated methods (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm). Only two of the five automated
test systems are sold in the United States. Because the current
regulation governing FOB tests does not specify automated or non-
automated FOB tests, it could be misconstrued that automated FOB test
systems are available for use by laboratories with a COW. As amended,
it will be clear that automated FOB test systems are not permitted for
use by a laboratory with a COW under Sec. 493.15(c)(2). This means
that testing sites using one or both of the two automated test systems
noted above (which are categorized as moderate complexity tests) would
be impacted by this rule if they are currently operating under a COW.
According to the information on automated analyzers for FOB testing
distributed in the United States provided by manufacturers, we estimate
that no more than 26 laboratories would be impacted by this regulatory
change. We developed a range of the estimated economic impact for
changes that may result from this final rule. Our highest estimate
totals approximately $151,000 for the first year, due to the initial
costs required to change certificate types for all potentially impacted
laboratories. This would decrease in years two through five, projected
to be as low as approximately $3,000 per year in years two and four,
when no certificate fees would be paid. Therefore, this rule does not
meet the economic threshold to be considered a major rule.
The RFA requires agencies to analyze options for regulatory relief
of small entities. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals and most other providers and suppliers
are small entities, either by nonprofit status or by having revenues of
less than $7.5 million to $38.5 million in any 1 year. Individuals and
states are not included in the definition of a small entity. We are not
preparing an analysis for the RFA because we believe that approximately
79 percent of United States medical laboratories qualify as small
entities based on their nonprofit status as reported in the American
Hospital Association Fast Fact Sheet, updated July 11, 2017 (https://www.aha.org/research/rc/stat-studies/fast-facts.shtml). However, as
previously described, due to the low number of automated analyzers
distributed in the United States, we estimate that no more than 26
laboratories would potentially be impacted by this regulatory change.
As its measure of significant economic impact on a substantial number
of small entities, HHS uses a change in revenue of more than 3 to 5
percent. We do not believe that this threshold would be reached by the
requirements in this final rule because very few small entities would
be subject to the provisions in this rule.
In addition, section 1102(b) of the Social Security Act (the Act)
requires us to prepare a regulatory impact analysis if a rule may have
a significant impact on the operations of a substantial number of small
rural hospitals. This analysis must conform to the provisions of
section 604 of the RFA. For purposes of section 1102(b) of the Act, we
define a small rural hospital as a hospital that is located outside of
a Metropolitan Statistical Area for Medicare payment regulations and
has fewer than 100 beds. We do not expect this final rule to have a
significant impact on a substantial number of small rural hospitals.
The changes in this final rule would apply only to the laboratories
previously described, which do not include any small rural hospitals at
this time. Thus, an analysis under section 1102(b) of the Act is not
required for this rulemaking.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2017, that
threshold is approximately $148 million. This rule will have no
consequential effect on state, local, or tribal governments or on the
private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on state
and local governments, preempts state law, or otherwise has Federalism
implications. Since this regulation does not impose any costs on state
or local governments, the requirements of Executive Order 13132 are not
applicable.
Executive Order 13771, entitled ``Reducing Regulation and
Controlling Regulatory Costs,'' was issued on January 30, 2017 (82 FR
9339, February 3, 2017). Section 2(a) of Executive Order 13771 requires
an agency, unless
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prohibited by law, to identify at least two existing regulations to be
repealed when the agency publicly proposes for notice and comment, or
otherwise promulgates, a new regulation. In furtherance of this
requirement, section 2(c) of Executive Order 13771 requires that the
new incremental costs associated with new regulations shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations. OMB's interim guidance,
issued on April 5, 2017, https://www.whitehouse.gov/the-press-office/2017/04/05/memorandum-implementing-executive-order-13771-titled-reducing-regulation, explains that for Fiscal Year 2017 the above
requirements only apply to each new ``significant regulatory action
that imposes costs.'' It has been determined that this final rule is
not a ``significant regulatory action thus does not trigger the above
requirements of Executive Order 13771.
List of Subjects in 42 CFR Part 493
Administrative practice and procedure, Grant programs--health,
Health facilities, Laboratories, Medicaid, Medicare, Penalties,
Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR part 493 as set forth below:
PART 493--LABORATORY REQUIREMENTS
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1. The authority citation for part 493 continues to read as follows:
Authority: Sec. 353 of the Public Health Service Act, secs.
1102, 1861(e), the sentence following sections 1861(s)(11) through
1861(s)(16) of the Social Security Act (42 U.S.C. 263a, 1302,
1395x(e), the sentence following 1395x(s)(11) through 1395x(s)(16)),
and the Pub. L. 112-202 amendments to 42 U.S.C. 263a.
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2. Section 493.15 is amended by revising paragraph (c)(2) to read as
follows:
Sec. 493.15 Laboratories performing waived tests.
* * * * *
(c) * * *
(2) Fecal occult blood-non-automated;
* * * * *
Dated: August 24, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Dated: October 5, 2017.
Anne Schuchat,
RADM, U.S. Public Health Service, Principal Deputy Director, Centers
for Disease Control and Prevention.
Dated: October 12, 2017.
Eric D. Hargan,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2017-22813 Filed 10-19-17; 8:45 am]
BILLING CODE 4120-01-P