[Federal Register Volume 82, Number 55 (Thursday, March 23, 2017)]
[Notices]
[Page 14895]
[FR Doc No: 2017-05820]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG17-78-000.
    Applicants: 83WI 8me.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of 83WI 8me.
    Filed Date: 3/17/17.
    Accession Number: 20170317-5063.
    Comments Due: 5 p.m. ET 4/7/17.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER17-1236-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Revisions to OATT Sch 12--
Appdx A re: RTEP Projects Approved by Board in Feb 2017 to be effective
6/15/2017.
    Filed Date: 3/17/17.
    Accession Number: 20170317-5064.
    Comments Due: 5 p.m. ET 4/7/17.

    Docket Numbers: ER17-1239-000.
    Applicants: Public Service Company of New Mexico.
    Description: Sec.  205(d) Rate Filing: Modifications to NITSA/NOA
between PNM and Navajo Tribal Utility to be effective 3/1/2017.
    Filed Date: 3/17/17.
    Accession Number: 20170317-5074.
    Comments Due: 5 p.m. ET 4/7/17.

    Docket Numbers: ER17-1241-000.
    Applicants: Deerfield Wind, LLC.
    Description: Baseline eTariff Filing: Baseline new to be effective
5/16/2017.
    Filed Date: 3/17/17.
    Accession Number: 20170317-5102.
    Comments Due: 5 p.m. ET 4/7/17.

    Docket Numbers: ER17-1242-000.
    Applicants: Tule Wind LLC.
    Description: Baseline eTariff Filing: Baseline new to be effective
5/16/2017.
    Filed Date: 3/17/17.
    Accession Number: 20170317-5103.
    Comments Due: 5 p.m. ET 4/7/17.

    Docket Numbers: ER17-1243-000.
    Applicants: Twin Buttes Wind II LLC.
    Description: Baseline eTariff Filing: Baseline new to be effective
5/16/2017.
    Filed Date: 3/17/17.
    Accession Number: 20170317-5104.
    Comments Due: 5 p.m. ET 4/7/17.

    Docket Numbers: ER17-1244-000.
    Applicants: Chambersburg Energy, LLC.
    Description: Sec.  205(d) Rate Filing: Reactive Service Rate
Schedule Filings to be effective 12/31/9998.
    Filed Date: 3/17/17.
    Accession Number: 20170317-5125.
    Comments Due: 5 p.m. ET 4/7/17.

    Docket Numbers: ER17-1245-000.
    Applicants: Gans Energy, LLC.
    Description: Sec.  205(d) Rate Filing: Reactive Service Rate
Schedule Filings to be effective 12/31/9998.
    Filed Date: 3/17/17.
    Accession Number: 20170317-5126.
    Comments Due: 5 p.m. ET 4/7/17.

    Docket Numbers: ER17-1246-000.
    Applicants: Springdale Energy, LLC.
    Description: Sec.  205(d) Rate Filing: Reactive Service Rate
Schedule Filings to be effective 12/31/9998.
    Filed Date: 3/17/17.
    Accession Number: 20170317-5127.
    Comments Due: 5 p.m. ET 4/7/17.

    Docket Numbers: ER17-1247-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original Service Agreement
No. 4656; Queue No. AA1-138 to be effective 2/15/2017.
    Filed Date: 3/17/17.
    Accession Number: 20170317-5145.
    Comments Due: 5 p.m. ET 4/7/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 17, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-05820 Filed 3-22-17; 8:45 am]
BILLING CODE 6717-01-P


information available to patients and healthcare providers that may
inform the selection of particular IVDs for use. Therefore, FDA is now
proposing to end the general enforcement discretion approach, via a
phaseout approach, with respect to premarket review requirements (as
applicable), QS requirements, and registration and listing requirements
for these tests, in addition to medical device reporting (MDR)
requirements (i.e., reporting of adverse events), correction and
removal reporting requirements, and other requirements applicable to
such tests. Based on the information available at this time, FDA has
made a preliminary determination that this proposal appropriately
balances the relevant considerations with respect to these tests,
including currently marketed IVDs offered as LDTs.
    However, FDA expects that some stakeholders will suggest that FDA
continue to maintain the current general enforcement discretion
approach with respect to premarket review and some or all QS
requirements for currently marketed LDTs or a subset of currently
marketed LDTs (i.e., what some previously referred to as
``grandfathering''). To the extent commenters suggest such an approach
for FDA's consideration, FDA requests information to support such an
approach, including the following:
     Given the information in the ``Need for the Rule'' section
of this preamble in particular, what would be the public health
rationale for generally exercising enforcement discretion with respect
to premarket review and some or all QS requirements, for LDTs that are
being offered as of the date of issuance of this proposed rule and are
not changed with respect to indications for use or performance after
that date? Please provide data to support such an approach. Also, if
you think there are steps that might help support such an approach,
including ideas that might help to address the public health concerns
discussed in the ``Need for the Rule'' section, please describe them,
and include a rationale and any supporting evidence.
     If commenters suggest maintaining the general enforcement
discretion approach with respect to premarket review and QS
requirements for a subset of LDTs (e.g., low and moderate risk LDTs)
currently on the market that are being offered as of the date of
issuance of this proposed rule and are not changed with respect to
indications for use or performance after that date, what would be the
public health rationale to support such an approach? Please provide any
data supporting such an approach. Also, if you think there are steps
that might help support such an approach, including ideas that might
help to address the public health concerns discussed in the ``Need for
the Rule'' section, please describe them and include a rationale and
any supporting evidence.
    FDA recognizes that the phaseout of the general enforcement
discretion approach described in this section may have a relatively
greater impact on small laboratories. Therefore, FDA seeks comment on
the following:
     Is there a public health rationale to have a longer
phaseout period for IVDs offered as LDTs by laboratories with annual
receipts below a certain threshold (e.g., $150,000) (see Table 43 in
the Preliminary Economic Analysis of Impacts (Ref. 34))? If so, please
provide relevant data and comment specifically on an alternative
recommended timeline.
    In addition, FDA is aware that some AMCs have claimed that their
laboratories operate under unique circumstances (such as being
integrated into direct patient care) and therefore their tests should
be treated differently than tests manufactured by other laboratories.
Although FDA is not aware of an established definition of an AMC
laboratory, one possible description is: a laboratory for which a
certificate is in effect under CLIA and that meets the requirements
under CLIA to perform tests of high-complexity; that is part of an
accredited public or nonprofit private AMC that has a medical residency
training program or fellowship program related to test development,
application, and interpretation; and that is integrated into the direct
medical care for a patient, including specimen collection, testing,
interaction with the treating provider, and, as appropriate, patient
treatment based on the test, all at the same physical location. FDA
seeks comments on the following:
     What are the characteristics of AMC laboratories? Do the
characteristics included above accurately describe

AMC laboratories and in fact distinguish them from other laboratories?
     Should FDA continue the general enforcement discretion
approach with respect to any requirements, such as premarket review
requirements, for tests manufactured by AMC laboratories?
     If FDA should continue the general enforcement discretion
approach with respect to any requirements, such as premarket review
requirements, for tests manufactured by AMC laboratories, are there any
additional considerations that should be taken into account with
respect to this approach, for example, whether an FDA cleared or
approved test is available for the same intended use as the test
manufactured by an AMC laboratory? Please provide a rationale and other
information (e.g., data) to support any additional considerations.
     If FDA should have a different policy for AMC
laboratories, what would be the public health rationale to support such
a policy? For example, if integration of an AMC laboratory into direct
patient care is included as a basis for a different policy, please
include a public health rationale when explaining why and how such
integration supports the different policy, and how integration could
ensure that there is a reasonable assurance of IVD safety and
effectiveness.
     If FDA should have a different policy for AMC
laboratories, is there evidence to support such a policy?
    FDA also is interested in and seeks comment on leveraging programs
such as the New York State Department of Health Clinical Laboratory
Evaluation Program (NYSDOH CLEP) or those within the Veterans Health
Administration (VHA), as appropriate. In particular, FDA requests
comment on whether it may be appropriate to continue the general
enforcement discretion approach, such that FDA generally would not
enforce any applicable device requirements, where outside programs can
be leveraged. If FDA should continue to exercise enforcement discretion
under these circumstances:
     What specific characteristics of and activities within
these programs justify such an approach?
     Should the scope of such a policy be more limited for each
program in question? For example, should FDA continue enforcement
discretion for premarket review requirements and intend to enforce
other requirements, such as reporting adverse events?
     Are there any additional considerations that should be
taken into account?
    Please provide a rationale and other information (e.g., data) to
support any suggestions.

B. Stages

    As previously discussed, FDA is proposing to gradually phase out
its current general enforcement discretion approach so that most IVDs
offered as LDTs would generally fall under the same enforcement
approach as other IVDs. In developing the proposed phaseout policy, FDA
has considered a number of factors, including the public health
importance of better assuring the safety and effectiveness of IVDs
offered as LDTs, the desire to avoid undue disruption to the testing
market, the time it may take for laboratories to come into compliance
with FDA requirements, the need for adequate resources to implement the
phaseout policy in a manner that does not undermine reasonable
expectations with regards to premarket review timing (per the Medical
Device User Fee Amendments (MDUFA) V agreement), and the benefits of a
relatively simple policy that can be easily understood and implemented.
Keeping these factors in mind, FDA has structured the phaseout policy
to contain five key stages:
     Stage 1: End the general enforcement discretion approach
with respect to MDR requirements and correction and removal reporting
requirements 1 year after FDA publishes a final phaseout policy, which
FDA intends to issue in the preamble of the final rule.
     Stage 2: End the general enforcement discretion approach
with respect to requirements other than MDR, correction and removal
reporting, QS, and premarket review requirements 2 years after FDA
publishes a final phaseout policy.
     Stage 3: End the general enforcement discretion approach
with respect to QS requirements 3 years after FDA publishes a final
phaseout policy.
     Stage 4: End the general enforcement discretion approach
with respect to premarket review requirements for high-risk IVDs 3\1/2\
years after FDA publishes a final phaseout policy, but not before
October 1, 2027.
     Stage 5: End the general enforcement discretion approach
with respect to premarket review requirements for moderate risk and low
risk IVDs (that require premarket submissions) 4 years after FDA
publishes a final phaseout policy, but not before April 1, 2028.
    Each of these stages is discussed in further detail below. For each
stage, FDA is proposing a period of time for laboratories to come into
compliance before FDA intends to end the general enforcement discretion
approach. FDA encourages laboratory manufacturers to begin early and
work toward compliance with requirements sooner than the end of the
specified timeframes. FDA also intends to consider providing more
targeted guidance and/or making additional resources available on
specific topics, such as compliance with applicable labeling
requirements, over the course of the phaseout period.
    1. Stage 1: End the general enforcement discretion approach with
respect to MDR requirements and correction and removal reporting
requirements 1 year after FDA publishes a final phaseout policy.
    FDA has structured the phaseout policy to obtain information about
potentially harmful IVDs offered as LDTs as soon as feasible. As
detailed elsewhere in this preamble, FDA is concerned that some of the
IVDs offered as LDTs may be posing risks to patients. Therefore, FDA is
prioritizing the phaseout of the general enforcement discretion
approach for requirements that would help FDA identify and monitor
significant issues with IVDs offered as LDTs, consistent with other
considerations described in this proposed policy.
    Enforcement of the MDR requirements under 21 U.S.C. 360i(a) through
(c) and 21 CFR part 803, in particular, would enable FDA to
systematically monitor significant adverse events to identify
problematic IVDs offered as LDTs, such as those with poor performance
or other safety issues. FDA has made a preliminary determination that
gathering this information is important for IVDs that do not have the
safeguards associated with compliance with other FDA requirements, such
as manufacturing under QS requirements or confirmation of analytical
and clinical validity through premarket review.
    For similar reasons, FDA is prioritizing the collection of
information about when a manufacturer has initiated a correction or
removal of its IVD to reduce a risk to health or to remedy a violation
of the FD&C Act that may present a risk to health. Under 21 U.S.C.
360i(g) and part 806 (21 CFR part 806), manufacturers are required to
report such corrections or removals to FDA, and FDA intends to phase
out the general enforcement discretion approach for these requirements
at the same time it does so for MDR requirements. Because FDA intends
for the phaseout of the general enforcement discretion approach with
respect to

correction and removal reporting requirements to occur before phaseout
of the general enforcement discretion approach with respect to
registration and listing requirements, FDA intends to exercise
enforcement discretion, such that it generally does not intend to
enforce, the requirement to use the establishment registration number
on such reports (21 CFR 806.10) when laboratories use their CLIA
certificate number instead prior to registering.
    FDA's proposal to phase out enforcement discretion for MDR
requirements within 1 year after finalization of the policy is informed
by comments FDA received in response to the draft guidance documents
that FDA issued in 2014 proposing to implement an oversight framework
for IVDs offered as LDTs. In 2014, FDA proposed a 6-month timeline for
laboratory compliance with MDR requirements (Ref. 48), and we received
comments suggesting that a longer period may be appropriate for the
establishment of a system to identify, review, and report adverse
events. Based in part on those comments, FDA is now proposing a 1-year
time period for laboratories to come into compliance with the MDR
requirements. In conjunction with the phaseout of the general
enforcement discretion approach with respect to the MDR requirements,
FDA is also proposing to end the general enforcement discretion
approach with respect to the requirements of part 806, concerning
reports of corrections and removals. Because MDRs frequently are a
basis for corrections and removals, FDA views these requirements as
working together to provide information to FDA about issues with device
performance or quality. We anticipate that this 1-year time period is
adequate, particularly given that laboratories should already have some
processes in place for detecting problems with their IVDs to comply
with CLIA regulations.
    2. Stage 2: End the general enforcement discretion approach with
respect to requirements not covered during other stages of the phaseout
policy 2 years after FDA publishes a final phaseout policy.
    FDA is proposing to end the general enforcement discretion approach
for requirements besides MDR, correction and removal reporting, QS, and
premarket review requirements 2 years after the final policy is
published. These other requirements include registration and listing
requirements under 21 U.S.C. 360 and part 807 (excluding subpart E);
labeling requirements under 21 U.S.C. 352 and parts 801 and 809,
subpart B; and investigational use requirements under 21 U.S.C. 360j(g)
and part 812. We have included compliance with investigational use
requirements at this stage, in recognition that there has been some
confusion about our enforcement approach in this area. Our
understanding is that laboratories often are not complying with
investigational use requirements currently, even though FDA has
generally expected compliance with these requirements.\17\ We are
therefore including these requirements in the phaseout policy.
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    \17\ For example, FDA stated in the ``Framework for Regulatory
Oversight of Laboratory Developed Tests (LDTs)'' draft guidance that
``FDA intends to continue to enforce investigational device
requirements under 21 CFR part 812 for all clinical investigations
of LDTs that are conducted under clinical protocols that require
institutional review board approval'' (Ref. 48).
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    FDA recognizes that this proposal is different from FDA's prior
statements in the 2017 Discussion Paper regarding oversight of IVDs
manufactured by laboratories with respect to certain requirements, for
which the timing of FDA's expectations for compliance generally
depended on the type of premarket review applicable to the device.
However, upon review, FDA anticipates that it would better serve the
public health and be simpler to phase out the general enforcement
discretion approach for these requirements at the 2-year mark. For
example, under this timeline, laboratories could work toward compliance
with the stage 2 requirements without necessarily determining the risk
category of their IVDs until later stages of the proposed phaseout
policy. Another advantage of this timeline is that FDA would obtain
registration and listing information before the enforcement discretion
phaseout date for premarket review requirements, which could give the
Agency an initial understanding of the universe of IVDs offered as LDTs
to facilitate premarket review of those IVDs. Based on its experience,
FDA anticipates that 2 years is adequate time to come into compliance
with the various requirements.
    3. Stage 3: End the general enforcement discretion approach with
respect to QS requirements 3 years after FDA publishes a final phaseout
policy.
    At the 3-year mark, FDA would expect compliance with the device
CGMP requirements of the QS requirements under 21 U.S.C. 360j(f) and
part 820 (21 CFR part 820). However, for IVDs for which all
manufacturing activities occur within a single CLIA-certified
laboratory that meets the regulatory requirements to perform high
complexity testing and for which distribution of the IVD does not occur
outside that single laboratory, FDA would expect compliance at the 3-
year mark with some, but not all, of the QS requirements. Although FDA
and CMS regulation are different and complementary, compliance with
CLIA requirements provides some quality assurances that may be relevant
to laboratories' manufacturing practices. In particular, laboratories
may in practice be able to apply concepts set forth under CLIA
requirements for laboratory operations to manufacturing activities
regulated by FDA. For FDA to effectively leverage the CLIA assurances,
this proposed approach would apply only when all manufacturing
activities occur within a single laboratory and the IVD is not
distributed outside that laboratory. However, even in the context of
this approach, there are certain QS requirements for which CLIA
regulations do not provide the assurances that FDA requirements would
provide. These requirements include design controls under 21 CFR
820.30; purchasing controls (including supplier controls) under 21 CFR
820.50; acceptance activities (receiving, in-process, and finished
device acceptance) under 21 CFR 820.80 and 21 CFR 820.86; corrective
and preventative actions (CAPA) under 21 CFR 820.100; and records
requirements under part 820, subpart M. Because CLIA does not provide
assurances relevant to these requirements, FDA is proposing to end the
general enforcement discretion approach for these specific requirements
for IVDs for which all manufacturing activities occur within a single
CLIA-certified laboratory that meets the regulatory requirements to
perform high complexity testing, and which are not distributed outside
that laboratory, 3 years after finalizing this policy. For all other
IVDs offered as LDTs and subject to this phaseout policy, FDA is
proposing to end the general enforcement discretion approach for all QS
requirements 3 years after finalizing this policy.
    Based on its experience, FDA anticipates that 3 years is adequate
time for laboratories to come into compliance with QS requirements. In
addition, based on the discussion above regarding concerns with the
quality and validation of IVDs offered as LDTs, FDA has made a
preliminary determination that phasing out the general enforcement
discretion approach for QS requirements later than 3 years would not be
in the best interest of the public health. Compliance with QS
requirements is critical to the quality and validity of IVDs offered as
LDTs.

For example, under the design controls of the QS requirements,
laboratories would, among other things, generally have better
procedures for validating the design of their tests, which would help
to ensure that they are analytically and clinically valid (see Ref.
76).
    FDA also notes that on February 23, 2022, FDA proposed to amend the
device QS regulation, part 820, to align more closely with
international consensus standards for devices (87 FR 10119). As stated
in that proposed rule, the requirements, if finalized, would be
substantially similar to the requirements of the current part 820,
providing a similar level of assurance in a firm's quality management
system, and FDA intends for this phaseout policy to apply with respect
to any regulations promulgated through that rulemaking.
    FDA intends to finalize amendments to the QS regulation
expeditiously, such that the amended QS requirements would be in effect
before the proposed beginning of stage 3. Upon the start of stage 3, or
if the laboratory complies with QS requirements prior to the start of
stage 3, FDA would expect compliance with the QS requirements that are
in effect at that time. For further information on the QS requirements
that would be established pursuant to the amendments to the QS
regulation, if finalized as proposed, please refer to the proposed
codified at 87 FR 10119 at 10133 and 10134. Notably, the requirements
relating to design controls, purchasing controls, acceptance
activities, CAPA, and records requirements are set forth in the
following ISO 13485 clauses as modified by the proposed codified for
part 820: Clause 4. Quality Management System, Subclause 4.2.5; Clause
6. Resource Management; Clause 7. Product Realization, Subclause 7.1,
Subclause 7.3, Subclause 7.4, and Subclause 7.4.3; and Clause 8.
Measurement, Analysis, & Improvement, Subclause 8.2.5, Subclause 8.2.6,
and Subclause 8.3.
    In addition, FDA notes that under section 515(d)(2) of the FD&C
Act, the Agency may not approve a PMA if the applicant fails to
demonstrate conformity with the QS requirements. Therefore, compliance
with the QS requirements is needed to support approval of a PMA. As
provided in section 520(f)(2) of the FD&C Act, any person subject to
the QS requirements may petition for an exemption or variance from any
QS requirement (see also 21 CFR 820.1).
    4. Stage 4: End the general enforcement discretion approach with
respect to premarket review requirements for high-risk IVDs 3\1/2\
years after FDA publishes a final phaseout policy, but not before
October 1, 2027.
    FDA proposes that the phaseout date for the general enforcement
discretion approach with respect to premarket review requirements for
high-risk IVDs offered as LDTs (IVDs that may be eligible for
classification into class III) should occur 3\1/2\ years from the time
that FDA issues a final phaseout policy. The premarket review
requirements are set forth in 21 U.S.C. 360e and 21 CFR part 814. FDA
is proposing this time period because it is mindful that phasing out
the general enforcement discretion approach on a timeline that is too
short could cause undue disruption in the testing market. Among other
things, we anticipate that 3\1/2\ years would provide sufficient notice
and opportunity for laboratories manufacturing IVDs to plan for and
prepare PMAs and would appropriately account for any reliance
interests. We note that 3\1/2\ years is a longer time period than was
discussed in either the 2014 draft guidance documents or the 2017
Discussion Paper for the phaseout of the general enforcement discretion
approach for premarket review requirements.
    This timeline is also intended to align the phaseout date for the
general enforcement discretion approach for premarket review
requirements for high-risk IVDs offered as LDTs with the start of
fiscal year 2028, which coincides with the beginning of a new user fee
cycle. This alignment would provide an opportunity for industry
participation in negotiations regarding the next user fee cycle with
the knowledge that laboratory manufacturers would be expected to comply
with premarket review requirements. (Although a trade association
representing laboratories previously has participated in MDUFA
negotiations, the prior negotiations have not incorporated similar
expectations regarding laboratory compliance with premarket
requirements.) Thus, we propose that this amount of time is appropriate
to foster stability and consistency in the marketplace for the current
MDUFA cycle, and would take into account the need for adequate FDA
resources to implement the phaseout policy in a manner that does not
compromise the capacity to achieve MDUFA V performance expectations.
FDA anticipates that during this 3\1/2\-year period, laboratories would
work with FDA to determine whether PMAs should be submitted for their
IVDs.
    Under FDA's proposed policy, FDA generally would not intend to
enforce against IVDs offered as LDTs after a PMA has been submitted
(within the 3\1/2\-year timeframe) until FDA completes its review of
the application. Given that such IVDs may already be on the market and
available to patients, FDA generally does not intend to interrupt
access at the point when a submission is made.
    Finally, FDA recognizes that the 2017 Discussion Paper described a
possible premarket-review approach specific to LDTs for unmet needs.
FDA has not included such an approach in this proposed policy because
we anticipate that the 3\1/2\-year timeframe should be sufficient for
laboratories to meet premarket review requirements for each of their
marketed IVDs, as applicable, including IVDs for unmet needs. FDA also
anticipates that programs currently in place may facilitate the
development and premarket authorization of IVDs for unmet needs. These
programs include the Humanitarian Use Devices (HUD)/Humanitarian Device
Exemption (HDE) program,\18\ which, among other things, provides an
exemption from the requirement to establish a reasonable assurance of
effectiveness for devices intended for use in the treatment or
diagnosis of rare diseases or conditions (21 U.S.C. 360j(m); 21 CFR
part 814, subpart H), and the Breakthrough Devices program, which is
intended to help expedite the development and review of certain devices
that provide for more effective treatment or diagnosis of life-
threatening or irreversibly debilitating diseases or conditions (21
U.S.C. 360e-3).
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    \18\ Under the proposed phaseout policy, laboratories that
intend to submit an HDE application should do so within the same
3\1/2\-year timeframe provided for submission of PMAs. As in the
case of PMAs, under FDA's proposed policy, FDA generally would not
intend to enforce against IVDs after an HDE application has been
submitted (within the 3\1/2\-year timeframe) until FDA completes its
review of the application.

    5. Stage 5: End the general enforcement discretion approach with
respect to premarket review requirements for moderate risk and low
risk IVDs (that require premarket submissions) 4 years after FDA
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publishes a final phaseout policy, but not before April 1, 2028.

    FDA is proposing to end the general enforcement discretion approach
with respect to premarket review requirements for moderate risk IVDs
offered as LDTs (IVDs that may be eligible for classification into
class II) and low risk IVDs offered as LDTs (IVDs that may be eligible
for classification into class I) that require a premarket submission 4
years after FDA publishes the final phaseout policy. These premarket
submissions include 510(k) submissions, the requirements for which are
set forth at 21 U.S.C. 360(k),

360c(i), and part 807, subpart E. These submissions also include De
Novo requests, which laboratories may submit for IVDs offered as LDTs
for which there is no legally marketed device upon which to base a
determination of substantial equivalence, and for which the laboratory
seeks classification into class I or class II. These requirements are
set forth at 21 U.S.C. 360c(f)(2) and 21 CFR part 860, subpart D.
    FDA intends this stage to begin no earlier than April 1, 2028.
FDA's reasons for proposing this time period to phase out the general
enforcement discretion approach with respect to premarket review
requirements for moderate risk and low risk IVDs offered as LDTs are
similar to those for the ``stage 4'' time period, except that FDA has
lengthened the time period by 6 months in order to prioritize the
review of applications for high-risk IVDs offered as LDTs (subject to
premarket approval requirements), so that FDA can focus first on IVDs
for which the consequences of a false result are most significant. FDA
also recognizes that a greater number of IVDs are subject to the 510(k)
requirements, as compared with premarket approval requirements, so a
longer period of time for laboratories to come into compliance with
these requirements may be appropriate, particularly for laboratories
with large test menus.
    FDA generally would not intend to enforce against IVDs offered as
LDTs after a 510(k) or De Novo request has been submitted (within the
4-year timeframe) until FDA completes its review of the submission.
    FDA also anticipates that laboratories may seek to utilize FDA's
Third Party review program. FDA currently operates a Third Party review
program for medical devices, and multiple organizations are accredited
to conduct reviews of 510(k) submissions for certain IVDs (see Ref.
77). We anticipate interest in the Third Party review program among
test manufacturers, as well as potential new Third Party review
organizations. In particular, FDA is aware of certain CLIA
accreditation organizations that may be interested in potentially
becoming Third Party reviewers under FDA's program, and to the extent
laboratories are already familiar with these organizations,
laboratories may be inclined to use the Third Party review program. In
addition, under the MDUFA V agreement, FDA is currently working to
enhance the Third Party review program, which may make it more
attractive to manufacturers including laboratories.

VII. Proposed Effective Date

    The Agency proposes that any final rule based on this proposed rule
will become effective 60 days after the date of publication of the
final rule in the Federal Register.

VIII. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 14094, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    Executive Orders 12866, 13563, and 14094 direct us to assess all
benefits, costs, and transfers of available regulatory alternatives and
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Rules are
``significant'' under Executive Order 12866 Section 3(f)(1) (as amended
by Executive Order 14094) if they ``have an annual effect on the
economy of $200 million or more (adjusted every 3 years by the
Administrator of [the Office of Information and Regulatory Affairs
(OIRA)] for changes in gross domestic product); or adversely affect in
a material way the economy, a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, territorial, or tribal governments or communities.'' OIRA has
determined that this proposed rule is a significant regulatory action
under Executive Order 12866 Section 3(f)(1).
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because most facilities that will be affected by
this rule are defined as small businesses and the proposed rule is
likely to impose a substantial burden on the affected small entities,
we find that the proposed rule will have a significant economic impact
on a substantial number of small entities.
    We prepared an analysis consistent with the Unfunded Mandates
Reform Act of 1995 (section 202(a)), which requires us to prepare a
written statement that includes estimates of anticipated impacts,
before proposing ``any rule that includes any Federal mandate that may
result in the expenditure by State, local, and tribal governments, in
the aggregate, or by the private sector, of $100,000,000 or more
(adjusted annually for inflation) in any one year.'' The current
threshold after adjustment for inflation is $177 million, using the
most current (2022) Implicit Price Deflator for the Gross Domestic
Product. This proposed rule would result in an expenditure in at least
one year that meets or exceeds this amount.
    This proposed rule, if finalized, would amend FDA's regulations to
make explicit that IVDs are devices under the FD&C Act including when
the manufacturer of the IVD is a laboratory. As discussed in section
VI, FDA intends to phase out its general enforcement discretion
approach for LDTs so that IVDs manufactured by a laboratory would
generally fall under the same enforcement approach as other IVDs.
    We anticipate that the benefits of phasing out FDA's general
enforcement discretion approach for LDTs would include a reduction in
healthcare costs associated with unsafe or ineffective tests, including
tests promoted with false or misleading claims, and from therapeutic
decisions based on the results of those tests. Quantified benefits are
the annualized sum of both health and non-health benefits. Unquantified
benefits would include the reduction in costs from lawsuits and
reduction in costs to healthcare systems.
    Table 1 summarizes the annualized benefits, costs, and transfers of
the proposed rule. At a 7 percent discount rate, 20-year annualized
benefits range from $2.67 billion to $86.01 billion, with a primary
estimate of $31.41 billion per year. At a 3 percent discount rate, 20-
year annualized benefits range from $1.81 billion to $61.41 billion,
with a primary estimate of $22.33 billion per year. At a 7 percent
discount rate, 20-year annualized costs range from about $2.52 billion
to $19.45 billion, with a primary estimate of $5.87 billion per year.
At a 3 percent discount rate, annualized costs range from about $2.39
billion to $18.55 billion, with a primary estimate of $5.60 billion per
year. At a 7 percent discount rate, 20-year annualized transfers range
from $100 million to $452 million, with a primary estimate of $226
million per year. At a 3 percent discount rate, 20-year annualized
transfers range from $121 million to $538 million, with a primary
estimate of $269 million per year.

                                         Table 1--Summary of Benefits, Costs and Transfers of the Proposed Rule
                                                             [Millions of 2022 U.S. dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                                ------------------------------------
                   Category                       Primary       Low        High                               Period                  Notes
                                                 estimate    estimate    estimate      Year      Discount     covered
                                                                                dollars    rate  (%)    (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized ($m/year)............     $31,408      $2,670     $86,013        2022           7          20
                                                    22,332       1,810      61,413        2022           3          20
    Annualized Quantified.....................  ..........  ..........  ..........  ..........           7
                                                                                3
                                               ---------------------------------------------------------------------------------------------------------
    Qualitative...............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized ($m/year)............       5,874       2,522      19,452        2022           7          20  A portion of foreign costs could
                                                     5,598       2,394      18,549        2022           3          20   be passed on to domestic
                                                                                consumers. We estimate that up
                                                                                to $30.73 million in annualized
                                                                                costs (7%, 20 years) to foreign
                                                                                facilities could be passed on
                                                                                to domestic consumers.
    Annualized Quantified.....................  ..........  ..........  ..........  ..........           7
                                                                                3
                                               ---------------------------------------------------------------------------------------------------------
    Qualitative...............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized ($m/year)....         226         100         452        2022           7          20
                                                       269         121         538        2022           3          20
                                               ------------------------------------------------------------------------
                                                From: Device Industry
                                                To: FDA
                                               ---------------------------------------------------------------------------------------------------------
    Other Annualized Monetized ($m/year)......  ..........  ..........  ..........  ..........           7
                                                                                3
                                               ------------------------------------------------------------------------
                                                From:
                                                To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local, or Tribal Government:.................................................................................................................
    Small Business: The proposed rule is likely to have a significant economic impact on a substantial number of small laboratories that manufacture
     IVDs offered as LDTs..
    Wages:..............................................................................................................................................
    Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 34) and at https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.

IX. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

X. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no new
collections of information. However, FDA does assume that there will
need to be corresponding adjustments to the burden estimates for
relevant approved collections of information before the relevant
phaseout stage begins and any such collection of information would not
be as a result of the implementation of the proposed rule. FDA
tentatively concludes that the following information collections will
need adjustment before the relevant phaseout stage begins: Office of
Management and Budget (OMB) control number 0910-0437, Medical Device
Reporting; OMB control number 0910-0359, Corrections and Removals; OMB
control number 0910-0625, Device Registration and Listing; OMB control
number 0910-0485, Labeling; OMB control number 0910-0078,
Investigational Device Exemption; OMB control number 0910-0073, Quality
Systems; OMB control number 0910-0231, Premarket Approval; OMB control
number 0910-0332, Humanitarian Device Exemption; OMB control number
0910-0756, Q-Submissions; OMB control number 0910-0120, Premarket
Notification; and OMB control number 0910-0844 De Novo. Such
adjustments will be submitted for review and clearance by OMB under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521).

XI. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.
Through publication of this proposed rule, we are providing notice and
an opportunity for State and local officials to comment on this
rulemaking.

XII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would have a
substantial direct effect on

one or more 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. The
Agency solicits comments from tribal officials on any potential impact
on Indian Tribes from this proposed action.

XIII. Other Issues for Consideration

    FDA anticipates that this proposed rule, if finalized, may require
conforming amendments to other FDA regulations, including provisions
regarding IVD labeling and ASRs in part 809. FDA intends to consider
and propose conforming amendments, where appropriate, at a future date.
    In addition, we note that various bills have been introduced in
Congress that would change the legal status of IVDs as devices (under
these bills, IVDs would generally be regulated as ``in vitro clinical
tests'' and would be subject to new statutory authorities).\19\ We
recognize that the enactment of such legislation would directly impact
this rule, given that it is being proposed under the statutory device
authorities and other authorities under the FD&C Act.
---------------------------------------------------------------------------

    \19\ See, e.g. H.R.4128--117th Congress (2021-2022): VALID Act
of 2021, H.R.4128, 117th Cong. (2021), https://www.congress.gov/bill/117th-congress/house-bill/4128/text; S.2209--117th Congress
(2021-2022): VALID Act of 2021, S.2209, 117th Cong. (2021), https://www.congress.gov/bill/117th-congress/senate-bill/2209.
---------------------------------------------------------------------------

XIV. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

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Size, Share & Trends Analysis Report By Technology (Immunoassay,
Molecular Diagnostics), By Application (Oncology, Nutritional &
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    2. The Pew Charitable Trusts, ``The Role of Lab-Developed Tests
in the In Vitro Diagnostics Market,'' October 2021. Available at
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Exists,'' Undark Magazine, February 1, 2023. Available at https://undark.org/2023/02/01/for-a-host-of-vital-lab-tests-no-fda-oversight-exists/.
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Their Prenatal Test. They Didn't Know the Industry Is an Unregulated
`Wild West,''' ProPublica, December 6, 2022. Available at https://www.propublica.org/article/how-prenatal-screenings-have-escaped-regulation.
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These Prenatal Tests Are Usually Wrong,'' New York Times, January 1,
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Changing Regulatory Landscape for Laboratory Developed Tests,''
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Developed Tests: Integrity Restored,'' JAMA, 2022;327(13):1229-1230.
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Developed Tests Fall Through the Cracks,'' MedPage Today, December
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Cases,'' ProPublica, May 16, 2022. Available at https://www.propublica.org/article/covid-testing-nevada-false-negatives-northshore.

    * 27. FDA, ``The FDA Warns Against the Use of Many Genetic Tests
With Unapproved Claims To Predict Patient Response to Specific
Medications: FDA Safety Communication,'' October 31, 2018. Available
at http://web.archive.org/web/20190909184258/https://www.fda.gov/medical-devices/safety-communications/fda-warns-against-use-many-genetic-tests-unapproved-claims-predict-patient-response-specific.
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Have False Results: FDA Safety Communication,'' April 19, 2022.
Available at https://www.fda.gov/medical-devices/safety-communications/genetic-non-invasive-prenatal-screening-tests-may-have-false-results-fda-safety-communication.
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    * 30. FDA, ``FDA Safety Communication: Breast Cancer Screening--
Nipple Aspirate Test Is Not an Alternative to Mammography,''
December 12, 2013. Available at http://web.archive.org/web/20131217065913/https:/www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm378389.htm.
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Incorrect Assignment of Test Results,'' September 1, 2016. Available
at https://wayback.archive-it.org/7993/20161021235406/http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm518907.htm.
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Illegally Marketing Genetic Test That Claims To Predict Patients'
Responses to Specific Medications,'' April 4, 2019. Available at
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Office Director, Office of In Vitro Diagnostics (OHT7), Center for
Devices and Radiological Health (CDRH), U.S. Food and Drug
Administration, RE: Examples of In Vitro Diagnostic Products (IVDs)
Offered as Laboratory Developed Tests (LDTs) that Raise Public
Health Concerns (September 22, 2023).
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Flexibility Analysis; Unfunded Mandates Reform Act Analysis.'' 2023.
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Testing for Inherited Cardiac Diseases in Underserved Populations of
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of Current Polygenic Risk Scores May Exacerbate Health
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15, 2021.
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in `a Bizarre Limbo,''' Bloomberg Law, August 26, 2020. Available at
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Limited FDA Review of Certain Covid-19 Tests,'' CNN, November 15,
2021. Available at https://www.cnn.com/2021/11/15/health/covid-lab-tests-hhs-withdraws-policy-bn/index.html.
    65. Fortune, ``Fortune 500--The Largest Companies in the U.S. by
Revenue,'' 2023. Available at https://fortune.com/ranking/fortune500/.
    * 66. FDA, ``Compliance Program Guidance Manual 7341.002;
Inspection of Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps).'' Available at https://www.fda.gov/media/73949/download.
    * 67. FDA, ``Compliance Program Guidance Manual 7342.002;
Inspection of Source Plasma Establishments, Brokers, Testing
Laboratories, and Contractors,'' January 31, 2019. Available at
https://www.fda.gov/media/80179/download.
    * 68. Government Accountability Office, ``COVID-19: FDA Took
Steps to Help Make Tests Available; Policy for Future Public Health
Emergencies Needed,'' May 2022. Available at https://www.gao.gov/assets/gao-22-104266.pdf.
    * 69. ``It Has Come to Our Attention'' Letter to MD Biosciences
re: the Zika Virus RNA by RT-PCR Assay (March 4, 2016). Available at
https://public4.pagefreezer.com/browse/FDA/22-02-2023T10:21/https://www.fda.gov/media/96214/download.
    * 70. ``It Has Come to Our Attention'' Letter to First
Diagnostic Corp. re: ATFirst One Step Zika Antibody Test (March 10,
2016). Available at https://public4.pagefreezer.com/content/FDA/04-10-2022T10:19/https://www.fda.gov/media/96739/download.
    * 71. FDA, ``Direct-to-Consumer Tests,'' December 20, 2019,
available at https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests (last accessed on March 9, 2023).
    * 72. Untitled Letter to Interleukin Genetics, Inc. (November 4,
2015). Available at https://public4.pagefreezer.com/browse/FDA/22-02-2023T10:21/https://www.fda.gov/media/94365/download.
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2015). Available at https://public4.pagefreezer.com/browse/FDA/30-12-2022T07:46/https://www.fda.gov/media/93493/download.
    * 74. Transcript of the Molecular and Clinical Genetics Panel
meeting, March 8, 2011. Available at https://wayback.archive-it.org/7993/20170404140959/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/UCM249857.pdf.
    * 75. Transcript of the Molecular and Clinical Genetics Panel
meeting, March 9, 2011. Available at https://wayback.archive-it.org/7993/20170404141000/https:/www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MolecularandClinicalGeneticsPanel/UCM249858.pdf.
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Clinical Laboratory Tests Can Benefit From Design Controls,'' Health
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    * 77. FDA, ``510(k) Third Party Review Program,'' August 19,
2022. Available at https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/510k-third-party-review-program(lastaccessedonSeptember22,2023).

List of Subjects in 21 CFR Part 809

    Labeling, Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, FDA proposes
to amend 21 CFR part 809 as follows:

PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

0
1. The authority citation for part 809 is revised to read as follows:

    Authority: 21 U.S.C. 321(h)(1), 331, 351, 352, 360, 360c, 360d,
360e, 360h, 360i, 360j, 371, 372, 374, 381.

0
2. In Sec.  809.3, revise the last sentence of paragraph (a) to read as
follows:

Sec.  809.3  Definitions.

    (a) * * * These products are devices as defined in section
201(h)(1) of the Federal Food, Drug, and Cosmetic Act (the act) and may
also be biological products subject to section 351 of the Public Health
Service Act, including when the manufacturer of these products is a
laboratory.
* * * * *

    Dated: September 27, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-21662 Filed 9-29-23; 8:45 am]
BILLING CODE 4164-01-P


                         Agenda for CEG 316(b) Meeting
                               December 2, 2011

   I. Meeting Objective

   II. Comparable Process for Impingement Mortality

   III. De Minimis Standard

   IV. Velocity Cap Definition as Pre Approved BTA

   V. Cooling Ponds/Cooling Towers as Pre Approved BTA and Cycles of Concentration Definition

   VI. Intake Velocity

   VII. Next Steps