[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Rules and Regulations]
[Pages 25910-25915]
[FR Doc No: 2018-11879]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 866, 876, 880, and 884

[Docket No. FDA-2017-N-1129]

Medical Devices; Exemptions From Premarket Notification: Class II
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
publishing an order to exempt a list of class II devices from premarket
notification (510(k)) requirements, subject to certain limitations.
This exemption from 510(k), subject to certain limitations, is
immediately in effect for the listed class II devices. This exemption
will decrease regulatory burdens on the medical device industry and
will eliminate private costs and expenditures required to comply with
certain Federal regulations. FDA is also amending the codified language
for the listed class II devices to reflect this final determination.
FDA is publishing this order in accordance with the section of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the
exemption of a device from the requirement to submit a 510(k).

DATES: This order is effective June 5, 2018.

FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices
and

Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave, Bldg. 66, Rm. 4676, Silver Spring, MD 20993-0002, 301-
796-6217.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the
implementing regulations, 21 CFR part 807, subpart E, require persons
who intend to market a new device to submit and obtain clearance of a
premarket notification (510(k)) containing information that allows FDA
to determine whether the new device is ``substantially equivalent''
within the meaning of section 513(i) of the FD&C Act (21 U.S.C.
360c(i)) to a legally marketed device that does not require premarket
approval.
    On December 13, 2016, the 21st Century Cures Act (Cures Act) (Pub.
L. 114-255) was signed into law. Section 3054 of the Cures Act amended
section 510(m) of the FD&C Act. As amended, section 510(m)(2) provides
that, 1 calendar day after the date of publication of the final list
under section 510(1)(B), FDA may exempt a class II device from the
requirement to submit a report under section 510(k) of the FD&C Act,
upon its own initiative or a petition of an interested person, if FDA
determines that a 510(k) is not necessary to provide reasonable
assurance of the safety and effectiveness of the device. This section
requires FDA to publish in the Federal Register a notice of intent to
exempt a device, or of the petition, and provide a 60-calendar-day
comment period. Within 120 days of publication of such notice, FDA
shall publish an order in the Federal Register that sets forth its
final determination regarding the exemption of the device that was the
subject of the notice.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
January 21, 1998, Federal Register notice (63 FR 3142) and subsequently
in the guidance the Agency issued on February 19, 1998, entitled
``Procedures for Class II Device Exemptions from Premarket
Notification, Guidance for Industry and CDRH Staff'' (``Class II 510(k)
Exemption Guidance''). That guidance can be obtained through the
internet at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf or by
sending an email request to [email protected] to receive a copy
of the document. Please use the document number 159 to identify the
guidance you are requesting.
    Accordingly, FDA generally considers the following factors to
determine whether premarket notification is necessary for class II
devices: (1) The device does not have a significant history of false or
misleading claims or of risks associated with inherent characteristics
of the device; (2) characteristics of the device necessary for its safe
and effective performance are well established; (3) changes in the
device that could affect safety and effectiveness will either (a) be
readily detectable by users by visual examination or other means such
as routine testing, before causing harm, or (b) not materially increase
the risk of injury, incorrect diagnosis, or ineffective treatment; and
(4) any changes to the device would not be likely to result in a change
in the device's classification. FDA may also consider that, even when
exempting devices, these devices would still be subject to the
limitations on exemptions.

III. Comments on the Proposed Exemption and FDA Response

    In the Federal Register of November 7, 2017 (82 FR 51633), FDA
published a notice (``November 2017 notice'') announcing its intent to
exempt, upon its own initiative, certain class II devices listed in
table 1 from 510(k) requirements, subject to certain limitations, and
provided opportunity for interested persons to submit comments by
January 8, 2018. After reviewing comments received, FDA is now
providing its final determination on exempting the certain class II
devices listed in table 1 from 510(k) requirements, subject to certain
limitations as identified in this order. FDA is also amending the
codified language for the classification regulations for the certain
class II devices listed in table 1 to reflect this final determination.
Persons with pending 510(k) submissions for devices that are now exempt
from 510(k), subject to the limitations, should withdraw their
submissions.
    In response to the November 2017 notice announcing FDA's intent to
exempt those device types from 510(k) requirements, FDA received a
submission from one commenter--a professional organization--opposing an
exemption from 510(k) for the genetic health risk assessment test
device type.
    To make it easier to identify comments and our responses, the word
``Comment'' appears in parentheses before the comment's description,
and the word ``Response'' in parentheses precedes the response.
Specific issues raised by the comment and the Agency's response
follows.
    (Comment) The commenter recommended FDA not exempt one-time FDA
reviewed genetic health risk assessment system devices from the 510(k)
requirement because there would be insufficient oversight to ensure the
analytical and clinical validity of these tests, consumers would be
misled regarding which tests FDA has affirmed are scientifically valid,
and concerns that, if one-time FDA reviewed genetic health risk
assessment system devices were exempted, consumers would not be assured
of being adequately informed about test quality. The commenter believed
it is not possible to assess the analytical and clinical validity of
all genetic health risks a company might offer by conducting a one-time
review of its `assessment system', as proposed by FDA. Such oversight,
it is argued, will only allow FDA to assess the analytical and clinical
validity, and `mitigate the risks of false negatives and positives',
for tests initially proposed by the company during this one-time
review. The commenter believed that it does not appear that there will
be assessment of the analytical or clinical validity of subsequent
tests offered, nor any assessment of the risks to the consumer of an
incorrect result. This commenter believed that FDA's proposal to exempt
one-time FDA reviewed genetic health risk assessment system devices
will not prevent scientifically invalid tests from being marketed to
the public and lacks a comprehensive assessment. Further, the commenter
argued that, after undergoing the one-time FDA review for genetic
health risk assessment tests, companies would be able to market
subsequent tests to the public as part of the same system and declare
that the tests meet FDA's standards. Such tests would not be held to
any specific standards of analytical or clinical validity. The public
would likely assume (and purveyors would likely advertise) that FDA had
reviewed and approved such tests as valid even though they had not been
reviewed by the Agency. The commenter also argued that there is a vast
range of quality (i.e., scientific merit) of direct-to-consumer (DTC)
genetic health risk assessment tests on the market. The commenter
argued that the market's current mixing of entertainment tests, which
make claims unsubstantiated by the scientific literature, with those
tests which have a clinical utility, are clinically valid, and can be
supported by current scientific

literature, is particularly confusing for the average consumer.
    (Response) We agree that the concerns raised above are important.
These concerns were considered during our review and development of the
initial classification regulation for genetic health risk assessment
system devices and in our consideration of whether to exempt one-time
FDA reviewed genetic health risk assessment system devices from the
510(k) requirement. We believe these concerns have been addressed and
accounted for in our determination that the 510(k) requirement is not
necessary to provide a reasonable assurance of safety and effectiveness
for these devices. We outline our rationale below.
    Consumer understanding of genetic risk is clearly an important
issue that was considered extensively by FDA in the context of genetic
health risk assessment system devices. This issue was balanced with the
increasing desire from the public to learn more about one's own genetic
makeup and how it affects genetic risk for health conditions. To ensure
that the tests and test reports are presented to the lay consumer in a
manner that is understandable, we employed several requirements.
Consumer understanding of the tests and associated test reports is
assured by user comprehension study requirements, specific labeling
requirements for these over-the-counter (OTC) tests, and general
requirements for devices. The special labeling requirements for these
devices under Sec.  866.5950(b) (21 CFR 866.5950(b)) include providing
information on the manufacturer's website about frequently asked
questions, available professional guidelines, and how to obtain access
to a genetic counselor.

A. User Comprehension Study

    A user comprehension study is required under Sec.
866.5950(b)(3)(iii)(M). The required user comprehension study must
assess comprehension of the test process and results by potential users
of the test with pre- and post-test user comprehension studies. This
study must be conducted on a statistically sufficient sample size of
non-trained individuals who represent the demographics of the United
States as well as a diverse range of age and educational levels. The
study must include directly evaluating a representative sample of the
material being presented to the user during use of the test. The test
that is given to the participants must be informed by a physician and/
or genetic counselor that identifies the appropriate general and
variant-specific concepts contained within the material being tested in
the user comprehension study to ensure that all relevant concepts are
incorporated in the study as well as having included the definition of
the target condition being tested and related symptoms, explain the
intended use and limitations of the test, explain the relevant
ethnicities in regard to the variant tested, explain genetic health
risks and relevance to the user's ethnicity, and assess participants'
ability to understand the following comprehension concepts: The test's
limitations, purpose, appropriate action, test results, and other
factors that may have an impact on the test results. The outcome of
this study has to meet rigorous standards, including meeting predefined
primary endpoint criteria, including a minimum of a 90 percent or
greater overall comprehension rate (i.e., selection of the correct
answer) for each comprehension concept. In addition, the testing must
follow a format where users have limited time to complete the studies
(such as an onsite survey format and a one-time visit with a cap on the
maximum amount of time that a participant has to complete the tests).
From our experience with user comprehension studies, the Agency
believes that meeting or exceeding these user comprehension study
requirements ensures that the materials presented to the user are
adequate for OTC use. The information the test provider must provide on
its website includes a summary table of comprehension rates regarding
comprehension concepts (e.g., purpose of test, test results, test
limitations, ethnicity relevance for the test results, etc.) for each
study report.

B. Frequently Asked Questions

    The manufacturer's website must have a frequently asked questions
section in the summary and technical information sections under Sec.
866.5950(b)(3)(ii)(C)(3) and (b)(3)(iii)(L)(3). For the frequently
asked questions sections, information must be included that is specific
for each variant/disease pair that is reported and scientifically valid
and supported by corresponding publications. Further information must
be included that explains the health condition/disease being tested,
the purpose of the test, the information the test will and will not
provide, the relevance of race and ethnicity on the test results,
information about the population to which the variants in the test is
most applicable, the meaning of the result(s), other risks factors that
contribute to disease, appropriate followup procedures, how the results
of the test may affect the user's family, including children, and links
to resources that provide additional information.

C. Resources

    Likely the test labeling information provided by the test
manufacturer will not be the sole source of information that the
consumer is seeking or even requires. For this reason, there are
requirements under Sec.  866.5950(b)(3)(ii)(C)(2) and (b)(3)(iii)(L)(2)
that the manufacturer of the test provide a pre-purchase page in the
summary and technical information sections that includes information
regarding professional guidelines for testing specific genes and
variants. Similar information must be provided in the frequently asked
questions section found in the summary and technical information
sections on the manufacturer's website, under Sec.
866.5950(b)(3)(ii)(C)(3) and (b)(3)(iii)(L)(3). These frequently asked
questions sections must include a statement about the current
professional guidelines for testing these specific gene(s) and
variant(s) and, if guidelines do not exist for certain genes or
variants being tested for, then this information must be provided as
well. Further, to facilitate more personalized support, under Sec.
866.5950(b)(1)(i)(E), test manufacturers are required to provide
information in the Sec.  809.10 (21 CFR 809.10) compliant labeling and
any pre-purchase page and test report generated regarding how a user
obtains access to a genetic counselor, board-certified clinical
molecular geneticist, or equivalent healthcare professional regarding
the results of a user's test.

D. Genetic Health Risk Assessment System Tests

    The tests that fall under the genetic health risk assessment system
regulation are identified in the regulation in Sec.  866.5950(a) as a
qualitative in vitro molecular diagnostic system used for detecting
variants in genomic deoxyribonucleic acid (DNA) isolated from human
specimens that will provide information to users about their genetic
risk of developing a disease to inform lifestyle choices and/or
conversations with a healthcare professional. This assessment system is
for OTC use. This device does not determine the person's overall risk
of developing a disease.
    The limitations that are most important for lay users to know about
the intended use of these tests that fall under this device type are
conveyed via the limiting statements required, under Sec.
866.5950(b)(1)(i), to be provided on the Sec.  809.10 compliant
labeling and any pre-purchase page and test report generated. One of
these limiting statements must explain that this test is

not intended to diagnose a disease, tell you anything about your
current state of health, or be used to make medical decisions,
including whether or not you should take a medication or how much of a
medication you should take. The limitations that are most important for
healthcare professionals to know about the intended use of tests that
fall under this device type are, under Sec.  866.5950(b)(1)(ii),
required to be provided in the Sec.  809.10 labeling and any test
report generated. These limitations include that the test is intended
to provide users with their genetic information to inform lifestyle
decisions and conversations with their doctor or other healthcare
professional and that any diagnostic or treatment decisions should be
based on testing and/or other information that a healthcare
professional determines to be appropriate for a patient.

E. Rigorous Validation Requirements

    FDA believes the analytical validation requirements are
sufficiently detailed in the special controls under Sec.
866.5950(b)(3)(iii)(J) that test providers will have no difficulty in
appropriately following these requirements. A high accuracy requirement
is necessary for tests that are provided under this regulation and
accuracy point estimates for all variants is required to be 99 percent
or higher under Sec.  866.5950(b)(3)(iii)(J)(1)(vii) or else they
cannot be claimed or reported. Once FDA has reviewed one test that
demonstrates this level of accuracy, then the test provider has
demonstrated an ability to meet the accuracy requirements for
additional similar tests offered.

F. Four Important Limitations on the Scope of the Classification
Regulation

    FDA agrees that there are four important express limitations to the
types of tests that can be offered under this classification regulation
even when these special controls are met. Tests cannot be offered under
this classification regulation that are indicated for prenatal testing;
predisposition for cancer where the result of the test may lead to
prophylactic screening, confirmatory procedures, or treatments that may
incur morbidity or mortality to the patient; assessing the presence of
genetic variants that impact the metabolism, exposure, response, risk
of adverse events, dosing, or mechanisms of prescription or OTC
medications; or assessing the presence of deterministic autosomal
dominant variants.

G. False or Misleading Claims

    It is a prohibited act for devices to have labeling that is false
or misleading in any particular manner, and thus FDA would deem such
device to be misbranded under section 502(a) of the FD&C Act (21 U.S.C.
352(a)). This prohibition would include prohibiting the manufacturer of
a genetic health risk assessment test device from falsely or
misleadingly representing a test as having been part of an original FDA
cleared device when it was added subsequently to FDA clearance. This
prohibition would also include falsely or misleadingly representing the
analytical or clinical validity of one of its tests. In addition, under
section 502(c) of the FD&C Act, it is a prohibited act and thus FDA
would deem a device to be misbranded if any information required on the
labeling of a device by FDA by or under the FD&C Act is not placed
prominently thereon with such conspicuousness and in such terms, as to
render it likely to be read and understood by the ordinary individual
under customary conditions of purchase and use. Thus, a genetic health
risk assessment test device for which a manufacturer later modified the
formerly compliant labeling to make the labeling such that the labeling
was not likely to be read and understood by the ordinary individual
under customary conditions of purchase and use would be a misbranded
device.

H. Conclusion

    In summary, all tests that are marketed under this classification
regulation must meet the general controls and the special controls that
are specified in the regulation. Ability of a manufacturer to meet
these special controls is demonstrated during the one-time review. Even
after the one-time review, the general controls and special controls
must continue to be met, including for all tests added or modified
after the one-time review of a manufacturer's device.

IV. Limitations on Exemptions

    FDA has determined that 510(k) is not necessary to assure the
safety and effectiveness of the class II devices listed in table 1.
This determination is based, in part, on the Agency's knowledge of the
device, including past experience and relevant reports or studies on
device performance (as appropriate), the applicability of general and
special controls, and the Agency's ability to limit an exemption.

A. General Limitations of Exemptions

    FDA's exemption from 510(k) for class II devices listed in table 1
applies only to those devices that have existing or reasonably
foreseeable characteristics of commercially distributed devices within
that generic type, or, in the case of in vitro diagnostic devices, for
which a misdiagnosis, as a result of using the device, would not be
associated with high morbidity or mortality. A manufacturer of a listed
device is still required to submit a 510(k) to FDA before introducing a
device or delivering it for introduction into commercial distribution
when the device meets any of the conditions described in Sec. Sec.
862.9 to 892.9 (21 CFR 862.9 to 21 CFR 892.9).

B. Partial Limitations of Exemptions

    In addition to the general limitations, FDA may also partially
limit an exemption from 510(k) requirements to specific devices within
a listed device type when initial Agency assessment determines that the
factors laid out in the Class II 510(k) Exemption Guidance do not weigh
in favor of exemption for all devices in a particular group. In such
situations where a partial exemption limitation has been identified,
FDA has determined that premarket notification is necessary to provide
a reasonable assurance of safety and effectiveness for these devices.
In table 1, for example, FDA is listing the exemption of the genetic
health risk assessment system, but limits the exemption to such devices
that have received a first-time FDA marketing authorization (e.g.,
510(k) clearance) for the genetic health risk assessment system (a
``one-time FDA reviewed genetic health risk assessment system''). FDA
has determined that a one-time FDA review (e.g., premarket
notification) of a genetic health risk assessment system is necessary
to provide reasonable assurance of the safety and effectiveness of the
device. FDA has determined that a one-time FDA review of a genetic
health risk assessment system is necessary to mitigate the risk of
false negatives and false positives by ensuring that certain
information be submitted to FDA to allow the Agency to assess the
safety and effectiveness of the devices as well as to ensure the
devices perform to acceptable standards.
    Exemption from the requirement of 510(k) does not exempt a device
from other applicable regulatory controls under the FD&C Act, including
the applicable general and special controls. This exemption from
510(k), subject to the limitations described above, is immediately in
effect for the device types identified in table 1. This exemption will
decrease regulatory burdens on the medical device industry and will
eliminate private costs and

expenditures required to comply with Federal regulations.

V. List of Class II Devices

    FDA is identifying the following list of class II devices that will
no longer require premarket notification under section 510(k) of the
FD&C Act, subject to the general limitations to the exemptions found in
Sec. Sec.  862.9 to 892.9 and any partial exemption limitations
identified in table 1:

                                            Table 1--Class II Devices
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                                                                                Partial exemption
           21 CFR section                   Device type            Product code       limitation (if applicable)
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862.1840............................  Total 25-hydroxyvitamin  PSL                   ...........................
                                       D Mass Spectrometry
                                       Test System.
866.5950............................  Genetic Health Risk      PTA                   Exemption is limited to a
                                       Assessment System.                             genetic health risk
                                                                                assessment system that has
                                                                                received a first-time FDA
                                                                                marketing authorization
                                                                                (e.g., 510(k) clearance)
                                                                                for the genetic health
                                                                                risk assessment system (a
                                                                                ``one-time FDA reviewed
                                                                                genetic health risk
                                                                                assessment system'').
876.1500............................  Endoscope Disinfectant   PUP                   ...........................
                                       Basin.
880.6710............................  Purifier, Water,         KMG                   ...........................
                                       Ultraviolet, Medical.
884.5960............................  Vibrator for             KXQ                   ...........................
                                       Therapeutic Use,
                                       Genital.
----------------------------------------------------------------------------------------------------------------

    FDA is revising the name of product code PUP to further clarify the
device type that this product code is intended to represent. The device
type was previously ``Endoscope Maintenance System.'' To more
accurately reflect the devices which fall within this device type
(product code PUP), the device type has been renamed ``Endoscope
Disinfectant Basin.'' Specifically, these devices are described as
``Wall-mounted tube(s) for holding disinfectant solution and endoscope
insertion tubes and accessories.'' This description has not changed
since publication of the November 2017 notice.

VI. Analysis of Environmental Impact

    The Agency has 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.

VII. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of
information found in other FDA regulations and guidance. These
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in part 807,
subpart E, regarding premarket notification submissions, have been
approved under OMB control number 0910-0120; and the collections of
information in 21 CFR parts 801 and 809, regarding labeling, have been
approved under OMB control number 0910-0485.

List of Subjects

21 CFR Part 862

    Medical devices.

21 CFR Part 866

    Biologics, Laboratories, Medical devices.

21 CFR Parts 876, 880, and 884

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
862, 866, 876, 880, and 884 are amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. In Sec.  862.1840, revise paragraph (b) introductory text to read as
follows:

Sec.  862.1840  Total 25-hydroxyvitamin D mass spectrometry test
system.

* * * * *
    (b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in part 807, subpart
E, of this chapter subject to the limitations in Sec.  862.9. The
device must comply with the following special controls:
* * * * *

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
3. The authority citation for part 866 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
4. In Sec.  866.5950, revise paragraph (b) introductory text to read as
follows:

Sec.  866.5950  Genetic health risk assessment system.

* * * * *
    (b) Classification. Class II (special controls). The genetic health
risk assessment system device, when it has previously received a first-
time FDA marketing authorization (e.g., 510(k) clearance) for the
genetic health risk assessment system (a ``one-time FDA reviewed
genetic health risk assessment system''), is exempt from the premarket
notification procedures in part 807, subpart E, of this chapter subject
to the limitations in Sec.  866.9. The device must comply with the
following special controls:
* * * * *

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
5. The authority citation for part 876 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
6. In Sec.  876.1500, revise paragraph (b)(1) to read as follows:

Sec.  876.1500  Endoscope and accessories.

* * * * *
    (b) * * *
    (1) Class II (performance standards). The device, when intended as
an endoscope disinfectant basin, which consists solely of a container
that holds disinfectant and endoscopes and accessories, is exempt from
the premarket notification procedures in part 807, subpart E, of this
chapter subject to the limitations in Sec.  876.9.
* * * * *

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
7. The authority citation for part 880 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
8. In Sec.  880.6710, revise paragraph (b) to read as follows:

Sec.  880.6710  Medical ultraviolet water purifier.

* * * * *
    (b) Classification. Class II (performance standards). The device is
exempt from the premarket notification procedures in part 807, subpart
E, of this chapter subject to the limitations in Sec.  880.9.

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
9. The authority citation for part 884 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
10 In Sec.  884.5960, revise paragraph (b) to read as follows:

Sec.  884.5960  Genital vibrator for therapeutic use.

* * * * *
    (b) Classification. Class II (performance standards). The device is
exempt from the premarket notification procedures in part 807, subpart
E, of this chapter subject to the limitations in Sec.  884.9.

    Dated: May 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11879 Filed 6-1-18; 8:45 am]
BILLING CODE 4164-01-P


Technical Support Document (TSD)

For the Modeling and Weight of Evidence (WOE) Portions of the Document Entitled “Cecil County, Maryland

8-Hour Ozone

State Implementation Plan and Base Year Inventory

SIP Revision:

07-05

June 15, 2007

TSD Prepared January, 2009

Todd A. Ellsworth

Air Quality Analysis Branch, 3AP22

U.S. Environmental Protection Agency, Region 3

1650 Arch Street

Philadelphia, Pennsylvania 19103

/S/

____________________________________________

Reviewed by Walter Wilkie, Chief

Air Quality Analysis Branch (3AP22)

January 6, 2009

_________________

Date Signed


 [Federal Register Volume 76, Number 130 (Thursday, July 7, 2011)] [Notices] [Pages 39963-39966] [FR Doc No: 2011-17053]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64796; File No. S7-28-11]

Order Pursuant to Section 36 of the Securities Exchange Act of

1934 Granting Temporary Exemptions From Clearing Agency Registration

Requirements Under Section 17A(b) of the Exchange Act for Entities

Providing Certain Clearing Services for Security-Based Swaps

July 1, 2011.

I. Introduction

    Title VII of the Dodd-Frank Wall Street Reform and Consumer

Protection Act of 2010 (``Dodd-Frank Act''),\1\ amends the Securities

Exchange Act of 1934 (``Exchange Act'') to provide for the

comprehensive regulation of security-based swaps \2\ by the Securities

and Exchange Commission (``Commission'').\3\ Among other things, Title

VII seeks to ensure that, wherever possible and appropriate,

derivatives contracts formerly traded exclusively in the over-the-

counter (``OTC'') market are centrally cleared.\4\ One of the key ways

in which the Dodd-Frank Act seeks to mitigate risk in the security-

based swap market is by requiring that entities that clear and settle

security-based swaps be registered with the Commission. Specifically,

section 763(b) of the Dodd-Frank Act adds a new section 17A(g) to the

Exchange Act, which directs entities that use instrumentalities of

interstate commerce to perform clearing agency functions for security-

based swaps to register with the Commission.\5\

---------------------------------------------------------------------------

    \1\ Public Law 111-203.

    \2\ Section 761(a)(6) of the Dodd-Frank Act defines a

``security-based swap'' as any agreement, contract, or transaction

that is a ``swap,'' as defined in section 1a(47) of the Commodity

Exchange Act, 7 U.S.C. 1a(47), that is based on an index that is a

narrow-based security index, a single security, or a loan, including

any interest therein or on the value thereof; or the occurrence,

nonoccurrence, or extent of the occurrence of an event relating to a

single issuer of a security or the issuers of securities in a

narrow-based security index, provided that such event directly

affects the financial statements, financial condition, or financial

obligations of the issuer. See section 3(a)(68) of the Securities

Exchange Act of 1934 (``Exchange Act''), 15 U.S.C. 78c(a)(68) (as

added by section 761(a)(6) of the Dodd-Frank Act). Section 712(d) of

the Dodd-Frank Act provides that the Commission and the Commodity

Futures Trading Commission (``CFTC''), in consultation with the

Board of Governors of the Federal Reserve System, shall, among other

things, jointly further define the terms ``swap'' and ``security-

based swap.'' See SEC Release No. 9204 (April 29, 2011), 76 FR 32880

(June 7, 2011) (proposing product definitions contained in Title VII

of the Dodd-Frank Act).

    \3\ Section 761(a)(2) of the Dodd-Frank Act includes security-

based swaps in the definition of ``security'' in section 3(a)(10) of

the Exchange Act, 15 U.S.C. 78c. See also section 768(a)(1) of the

Dodd-Frank Act (amending section 2(a)(1) of the Securities Act of

1933, 15 U.S.C. 77b(a)(1), to include security-based swaps in the

definition of ``security'').

    \4\ See, e.g., Report of the Senate Committee on Banking,

Housing, and Urban Affairs regarding The Restoring American

Financial Stability Act of 2010, S. Rep. No. 111-176 at 34 (stating

that ``[s]ome parts of the OTC market may not be suitable for

clearing and exchange trading due to individual business needs of

certain users. Those users should retain the ability to engage in

customized, uncleared contracts while bringing in as much of the OTC

market under the centrally cleared and exchange-traded framework as

possible.'').

    \5\ Public Law 111-203 Sec.  763(b).

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    Section 763(b) of the Dodd-Frank Act also directs the Commission,

by adding new sections 17A(i) and (j) of the Exchange Act, to adopt

rules for the implementation of the registration requirement in new

section 17A(g). The Title VII amendments for which rules are not

required generally are effective on July 16, 2011 (360 days after

enactment of the Dodd-Frank Act, referred to herein as the ``Effective

Date''). Provisions that require rules for implementation become

effective not less than 60 days after publication of the related final

rule or on July 16, 2011, whichever is later.\6\

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    \6\ See section 774 of the Dodd-Frank Act, 15 U.S.C. 77b note.

See also Exchange Act Release No. 64678 (June 15, 2011), granting

temporary exemptions and other temporary relief, together with

information on compliance dates for new provisions of the Exchange

Act applicable to security-based swaps.

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    Section 17A(j) of the Exchange Act requires the Commission to adopt

rules governing persons that are registered as clearing agencies for

security-based swaps under the Exchange Act.\7\ Section 17A(i) of the

Exchange Act provides that, to be registered and to maintain

registration as a clearing agency that clears security-based swap

transactions, a clearing agency must comply with such standards as the

Commission may establish by rule.\8\ Consistent with these provisions,

as well as provisions in Title VIII of the Dodd-Frank Act,\9\ the

Commission on March 3, 2011 proposed rules regarding registration of

clearing agencies and the operation and governance of clearing

agencies, including clearing agencies that clear security-based

swaps.\10\ Pursuant to section 774 of the Dodd-Frank Act, discussed

above, compliance with section 17A(g) of the Exchange Act will not be

required as of the Effective Date because sections 17A(i) and (j)

require rulemaking to implement the registration requirement pursuant

to section 17A(g) of clearing agencies that clear security-based swap

transactions.\11\ Instead compliance with section 17A(g) of the

Exchange Act will be required not less than 60 days after the

publication of final rules relating to registration of clearing

agencies that clear security-based swaps pursuant to sections 17A(i)

and (j) of the Exchange Act.

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    \7\ Public Law 111-203 Sec.  763(b).

    \8\ Id.

    \9\ Title VIII of the Dodd-Frank Act, entitled the Payment,

Clearing, and Settlement Supervision Act of 2010 (``Clearing

Supervision Act''), establishes an enhanced supervisory and risk

control system for systemically important clearing agencies and

other financial market utilities (``FMUs''). It provides that the

Commission may prescribe regulations containing risk management

standards, taking into consideration relevant international

standards and existing prudential requirements, for any designated

clearing entities it regulates. See section 805(a)(2) of the

Clearing Supervision Act. Those regulations may govern: ``(A) the

operations related to payment, clearing, and settlement activities

of such designated clearing entities; and (B) the conduct of

designated activities by such financial institutions.'' 12 U.S.C.

5464(a)(2).

    \10\ Securities Exchange Act Release No. 64017 (March 3, 2011),

76 FR 14472 (March 16, 2011) (File No. S7-08-11) (the ``Clearing

Agency Proposing Release'').

    \11\ Securities Exchange Act Release No. 64678 (June 15, 2011)

76 FR 36287 (June 22, 2011) (File No. S7-24-11) (Temporary

Exemptions and Other Temporary Relief, Together With Information on

Compliance Dates for New Provisions of the Securities Exchange Act

of 1934 Applicable to Security-Based Swaps).

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    In contrast to section 17A(g) of the Exchange Act, the registration

requirement of section 17A(b) of the Exchange Act, which applies to all

clearing agencies, will apply to security-based swap clearing agencies

when the provision of the Dodd-Frank Act that amends the definition of

``security'' under the Exchange Act to include security-based swaps

becomes effective, i.e., on the Effective Date.\12\

Accordingly, absent relief by the Commission, any entity that functions

as a clearing agency for security-based swaps would be required to

register with the Commission pursuant to section 17A(b)(1) of the

Exchange Act as of the Effective Date.\13\

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    \12\ See section 761(a)(2) of the Dodd-Frank Act (amending

section 3(a)(10) of the Exchange Act, 15 U.S.C. 78c(a)(10)).

    \13\ Section 17A(b)(1) provides (with limited exceptions) that

it shall be unlawful for any clearing agency, unless registered in

accordance with this subsection, directly or indirectly, to make use

of the mails or any means or instrumentality of interstate commerce

to perform the functions of a clearing agency with respect to any

security. 15 U.S.C. 78q-1(b)(1). Upon the effective date of section

761(a)(2), security-based swaps will be included in the definition

of a security in section 3(a)(10). See supra note 3.

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    The Commission notes that the term ``clearing agency'' under

section 3(a)(23)(A) of Exchange Act is defined broadly to include any

person who:

     Acts as an intermediary in making payments or deliveries

or both in connection with transactions in securities;

     Provides facilities for the comparison of data regarding

the terms of settlement of securities transactions, to reduce the

number of settlements of securities transactions, or for the allocation

of securities settlement responsibilities;

     Acts as a custodian of securities in connection with a

system for the central handling of securities whereby all securities of

a particular class or series of any issuer deposited within the system

are treated as fungible and may be transferred, loaned, or pledged by

bookkeeping entry, without physical delivery of securities certificates

(such as a securities depository); or

     Otherwise permits or facilitates the settlement of

securities transactions or the hypothecation or lending of securities

without physical delivery of securities certificates (such as a

securities depository).\14\

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    \14\ 15 U.S.C. 78c(a)(23)(A).

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    Based on this broad definition, the Commission indicated in the

``Clearing Agency Proposing Release'' that it preliminarily believes

that certain service providers that facilitate security-based swap

contract management may meet the clearing agency definition.\15\ The

Clearing Agency Proposing Release has only recently been issued and the

Commission is still considering these services in the context of the

Clearing Agency Proposing Release and the comments received on the

proposing release. Specifically, the Commission indicated it

preliminarily believes that Collateral Management Services, Trade

Matching Services, and Tear Up and Compression Services (as defined

below), if engaged in by security-based swap market participants, would

qualify these participants as clearing agencies and therefore trigger

the statutory requirement to register as clearing agencies: \16\

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    \15\ See Securities Exchange Act Release No. 64017, supra note

9.

    \16\ The Commission stresses that the functions highlighted

herein and in the Clearing Agency Proposing Release are not an

exhaustive list and urges each security-based swap service provider

to consider whether its functions place it within the clearing

agency definition.

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     ``Collateral Management Services'': Collateral management

generally involves calculating collateral requirements and facilitating

the transfer of collateral between counterparties. In the Clearing

Agency Proposing Release, the Commission stated that entities that

calculate net payment obligations among counterparties for security-

based swaps and provide instructions for payments, including with

respect to quarterly interest, credit events, and upfront fees, are

likely acting as intermediaries in making payments or deliveries or

both in connection with transactions in securities.

     ``Trade Matching Services'': Trade matching generally is

the process whereby an intermediary compares each market participant's

trade data regarding the terms of settlement of securities

transactions, in order to reduce the number of settlements of

securities transactions, or to allocate securities settlement

responsibilities. This includes activities of an intermediary that

captures trade information regarding a securities transaction and

performs an independent comparison of that information that results in

the issuance of binding matched terms to the transaction.\17\

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    \17\ See also Exchange Act Release No. 39829 (April 6, 1998), 63

FR 17943 (April 13, 1998) (File No. S7-10-98) (``A vendor that

provides a matching service will actively compare trade and

allocation information and will issue the affirmed confirmation that

will be used in settling the transaction.'').

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     ``Tear Up and Compression Services'': \18\ Based on

discussions between the Commission staff and market participants, the

Commission understands that tear up and compression service providers

generally operate in the following manner:

---------------------------------------------------------------------------

    \18\ Tear-up or multilateral portfolio trade compression

services for OTC derivatives seek to eliminate unnecessary or

duplicative trades from the market while maintaining a market

participant's overall exposure or risk in the market. This allows

dealers to reduce operational risk, freeing up liquidity and

capital. By reducing the gross notional outstanding of OTC

derivatives in normal times, portfolio trade compression provides

effective measures to address the risk to individual dealers

associated with uncoordinated, disorderly close-out transactions of

the positions of a defaulting major dealer. Compression is offered

by several vendors, and major market participants are now engaged in

regular compression exercises. See Financial Stability Board,

Implementing OTC Derivatives Market Reforms, (October 25, 2010),

available at http://www.Financialstabilityboard.org/publications/r_101025.pdf.

---------------------------------------------------------------------------

     The providers execute an algorithm seeking to reduce the

gross notional value of trades and the total number of trades but do

not alter the counterparty risk or market risk associated with the

trades beyond specified parameters.

     When using a tear up and compression service, the users

send all transactions they are willing to terminate to the service.

Each user sets tolerances for counterparty exposures it is willing to

absorb and how much money it is willing to pay in trade termination

costs. The submitted transactions are matched using an algorithm and

tolerances specified by the user.

     The service then proposes terminations across all parties

who participated, including payments for termination. The users

consider the proposal, check their own records, and, if they choose to

accept the proposal, fax or otherwise notify their acceptance to the

service. If the service receives acceptances from all users, the

transaction is considered binding, and the relevant transactions are

considered terminated.

     The users generally exchange payments and confirmations

outside the service. The tear up and compression service provider sends

the completed files to a third party service provider for matching, and

the ``torn up'' transactions are terminated in bulk at the security-

based swap data repository, which maintains a record of which parties

terminated the ``torn up'' trades.

    The Commission is using its authority under section 36 of the

Exchange Act \19\ to provide a conditional temporary exemption, until

the compliance date for the final rules relating to registration of

clearing agencies that clear security-based swaps pursuant to sections

17A(i) and (j) of the Exchange Act, from the registration requirement

in section 17A(b)(1) of the Exchange Act to any clearing agency that

may be required to register with the Commission solely as a result of

providing Collateral Management Services, Trade Matching Services, Tear

Up and Compression Services, and/or substantially similar services for

security based swaps (the ``Exempted Activities''). As discussed below,

the Commission believes that such action is necessary and appropriate

in the public interest and consistent with the protection of investors

because this conditional temporary exemption would avoid the potential

for disruption

of these important services to investors pending the implementation of

the registration framework and related standards and operational

requirements contemplated under sections 17A(g), (i), and (j) of the

Exchange Act, and pending further consideration of the appropriate

regulatory treatment of persons conducting Exempted Activities. The

Commission also believes that the temporary conditional exemption is

necessary and appropriate because it will provide legal certainty to

the security-based swap market and security-based swap market

participants.

---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78mm.

---------------------------------------------------------------------------

II. Discussion

    Our action today provides a temporary exemption, until the

compliance date for the final rules relating to registration of

clearing agencies that clear security-based swaps pursuant to sections

17A(i) and (j) of the Exchange Act, from section 17A(b)(1) of the

Exchange Act to persons conducting Exempted Activities. This temporary

exemption is subject to a condition that is designed to provide greater

information regarding persons that are using this exemption to conduct

Exempted Activities and the nature of these activities.\20\

Specifically, entities relying on the temporary exemption must provide

notice to the Commission with identifying information consisting of the

full legal name of the person, a description of the person's corporate

structure, contact person and contact information. Such indentifying

information is needed to provide the Commission with information

regarding who is seeking to use the exemption and how to contact such

persons. In addition, they must provide the Commission with a detailed

description of the Exempted Activities they conduct, including the

nature of services performed, number and nature of parties to whom

services are provided, and the volume of transactions conducted in

connection with the services performed for each of the last two years.

The Commission is requiring this information in order to better

understand the types of services that are being provided pursuant to

this exemption and the role such services play in the security-based

swap market. The notice must be provided to the Commission within

twenty-one days of relying on this exemption. The Commission believes

twenty-one days should provide sufficient time for an entity to prepare

the information required in the notice, including a detailed

description of the Exempted Activities it provides.

---------------------------------------------------------------------------

    \20\ The Paperwork Reduction Act of 1993 (``PRA''), 44 U.S.C.

3501 et seq., defines a ``collection of information'' as ``the

obtaining, causing to be obtained, soliciting or requiring the

disclosure to third parties or the public, of facts or opinions by

or for an agency, regardless of form or format, calling for * * *

answers to identical questions posed to, or identical reporting or

recordkeeping requirements imposed on, ten or more persons * * *.''

44 U.S.C. 3502(3)(A). The Commission preliminarily does not believe

that the reporting and recordkeeping provisions in this Order

contain ``collection of information requirements'' within the

meaning of the PRA because fewer than ten persons are expected to

rely on the exemption based on our discussions with industry

participants regarding entities engaged in Exempted Activities.

---------------------------------------------------------------------------

    In light of the condition to this exemptive order and the temporary

duration of the relief, the Commission believes this exemption should

help to facilitate the aim of the Dodd-Frank Act to ensure that

clearing functions are appropriately utilized to reduce risk in the OTC

market for derivatives.\21\ Entities that conduct Exempted Activities

can play an important role in facilitating risk reduction in the

security-based swap market, including by helping to reduce the

outstanding number of trades and providing useful operational functions

for clearing security-based swaps. Persons conducting Exempted

Activities, to the extent they are required to register under section

17A(g), will need time to consider and come into compliance with

requirements yet to be adopted by the Commission pertaining to clearing

agencies that clear security-based swaps. As a result, absent the

exemption granted by this order, the ability of such entities to

continue to provide these services may be disrupted, resulting in

potential lapses in the provision of these services.\22\

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    \21\ See supra note 4 and accompanying text.

    \22\ Entities that act as central counterparties for security-

based swaps will need to be registered with the Commission as

clearing agencies. However, the entities that currently perform the

vast majority of central counterparty services with respect to

security-based swaps will be deemed registered with the Commission

pursuant to Exchange Act section 17A(l). See Public Law 111-203

Sec.  763(b).

---------------------------------------------------------------------------

    The exemption will be effective until the compliance date for the

final rules relating to registration of clearing agencies that clear

security-based swaps pursuant to sections 17A(i) and (j) of the

Exchange Act. This limited duration will permit the Commission to

implement the statutory provisions pertaining to the registration of

clearing agencies that clear security-based swaps without disrupting

existing services. It will also permit the Commission to gain more

information concerning the number and types of entities that conduct

Exempted Activities, to learn more about how those activities

contribute to a national system for the clearance and settlement of

security-based swap transactions, and to evaluate the appropriate

regulatory treatment of those entities. The limited duration of the

exemption will also permit the entities conducting Exempted Activities

to review their operations, procedures and processing requirements in

the context of the new requirements stemming from the Dodd-Frank Act.

III. Solicitation of Comments

    The Commission requests comment on this exemption for clearing

agencies that may be required to register with the Commission solely as

a result of their conducting the Exempted Activities. The Commission is

soliciting public comment on all aspects of this exemption, including

whether the condition to the temporary exemption is appropriate or

alternatively whether the Commission should consider modifying this

condition in the future. Why or why not? Should other conditions apply?

If so, what conditions and why?

    Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/other.shtml);

     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number S7-28-11 on the subject line; or

     Use the Federal eRulemaking Portal (http://www.regulations.gov/). Follow the instructions for submitting comments.

Paper Comments

    A. Send paper comments in triplicate to Secretary, Securities and

Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number S7-28-11. This file number

should be included on the subject line if e-mail is used. To help us

process and review your comments more efficiently, please use only one

method. The Commission will post all comments on the Commission's

Internet Web site (http://www.sec.gov/rules/other.shtml). Comments are

also available for public inspection and copying in the Commission's

Public Reference Room, 100 F Street, NE., Washington, DC 20549, on

official business days between the hours of 1 a.m. and 3 p.m. All

comments received will be posted without change; we do not edit

personal identifying information from submissions. You should submit

only information that you wish to make available publicly.

IV. Conclusion

    It is hereby ordered, pursuant to section 36(a) of the Exchange

Act, that, until the compliance date for final rules issued by the

Commission pursuant to sections 17A(i) and (j) of the Exchange Act

relating to registration of clearing agencies that clear security-based

swaps:

    Any person that would otherwise be required to register with the

Commission as a clearing agency under section 17A(b)(1) of the Exchange

Act solely as a result of conducting Exempted Activities with respect

to security based swaps shall be exempt from section 17A(b)(1) of the

Exchange Act, provided that such person shall submit, within twenty-one

days of relying on this exemption, a notice to the Commission \23\ that

includes the full legal name of the person, a description of the

person's corporate structure, contact person and contact information,

and a detailed description of the Exempted Activities for security-

based swaps conducted by the person, including the nature of services

performed, number and nature of parties to whom services are provided,

and the volume of transactions conducted in connection with the

services performed for each of the last two years.

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    \23\ Any such notice should be sent to: Secretary, Securities

and Exchange Commission, 100 F Street, NE., Washington, DC 20549,

and be noted as regarding this ``File No. S7-28-11.''

By the Commission.

Elizabeth M. Murphy,

Secretary.

[FR Doc. 2011-17053 Filed 7-6-11; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: July 31, 2009 (Volume 74, Number 146)]
[Notices]
[Page 38177]
[DOCID:fr31jy09-44]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13526-000]

The Bowersock Mills and Power Company; Notice of Preliminary
Permit Application Accepted for Filing and Soliciting Comments, Motions
To Intervene, and Competing Applications

July 27, 2009.

    On June 24, 2009, The Bowersock Mills and Power Company filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act, proposing to study the feasibility of The Bowersock
Mills and Power Company Kansas River Project, which is located on the
Kansas River in Douglas County, Kansas. The sole purpose of a
preliminary permit, if issued, is to grant the permit holder priority
to file a license application during the permit term. A preliminary
permit does not authorize the permit holder to perform any land
disturbing activities or otherwise enter upon lands or waters owned by
others without the owners' express permission.
    The proposed project would operate run-of-river and consist of the
following:

    (1) The existing 665-foot-long, 17-foot-high timber-crib
Bowersock Dam; (2) a 120-foot-long gated spillway with seven gates;
(3) raising existing flashboards from 4-foot-high to 5.5-foot-high
flashboards; (4) an existing 4.3 mile-long reservoir having a normal
water surface elevation of 813.5 feet mean sea level; (5) an
existing South powerhouse containing seven turbine/generator units
(6) a proposed North powerhouse housing four turbine/generator
units; (7) a proposed 20-foot-wide Taintor gate; (8) a new intake
flume with trashracks; (9) a new 150-foot-long recreational boat
portage located at the north bank of the Kansas River; (10) a new
765-foot-long, 12-kilovolt (kV) transmission line connecting to an
existing 535-foot-long 2.3 kV transmission line; and (8) appurtenant
facilities. The proposed project would have a total capacity of 7.15
megawatts (MW) and an average annual generation of 33 gigawatt-
hours.

    Applicant Contact: Sarah Hill-Nelson, The Bowersock Mills and Power
Company, P.O. Box 66, Lawrence, Kansas 66044; phone:<PHONE_NUMBER>.
    FERC Contact: Monte TerHaar,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project, including a copy of
the application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13526) in the docket number field to access
the document. For assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-18298 Filed 7-30-09; 8:45 am]

BILLING CODE 6717-01-P