Comment Info: =================

General Comment:I am writing to request that the comment period be extended for organizations making comments. I was a moderately heavy user of analog devices (e.g., cigarettes) and have moved to electronic devices (e.g., e-cigarette). In the last eight months I have completely stopped using tobacco products such as cigarettes and chewing but do enjoy vapor on a regular basis. I use various levels of nicotine in the liquids that I enjoy, with my favorite currently being a nicotine free peach flavor. However, despite this new habit/hobby, I do not know much about electronic cigarettes and these juices. I would ask that the comment period be extended to allow organizations to more fully present their evidence and make their arguments both for and against these products to assist the FDA in this process.


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on November 16, 2007

   NOTICE OF ACTION TAKEN -- DOCKET DOT-OST-2004-17960

________________________________________________________________________
________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of ATLANTIC SOUTHEAST AIRLINES, INC. (ASA) filed 3/27/06
for:

XX  Renewal of exemption for two years under 49 U.S.C. 40109 to provide
the following service:

Scheduled foreign air transportation of persons, property, and mail
between Atlanta, Georgia and Providenciales, Turks and Caicos, and
authority to integrate this authority with ASA’s existing certificate
and exemption authority.  ASA operates this service as a “Delta
Connection” carrier.

Applicant rep: Robert E. Cohn<PHONE_NUMBER>    DOT Analyst: Thuy H.
Cooper<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The above action was effective when taken: November 16, 2007, through
November 16, 2009.

Action taken by:  Paul L. Gretch, Director

		     Office of International Aviation

XX  The authority granted is consistent with the U.S.-U.K. Air Services
Agreement.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated: XX Holder’s
certificates of public convenience and necessity

    XX Standard exemption conditions (attached)

________________________________________________________________________
_______________

Conditions:  The route integration authority granted is subject to the
condition that such operations are consistent with the applicable
bilateral aviation agreements.  Furthermore, (a) nothing in the award of
the route integration authority requested should be construed as
conferring upon ASA rights (including fifth-freedom intermediate and/or
beyond rights) to serve markets where U.S. carrier entry is limited
unless ASA first notifies the Department of its intent to serve such a
market and unless and until the Department has completed any necessary
carrier selection procedures to determine which carrier(s) should be
authorized to exercise such rights; and (b) should there be a request by
any carrier to use the limited-entry route rights that are included in
ASA’s authority by virtue of the route integration authority granted
here, but that are not then being used by ASA, the holding of such
authority by route integration will not be considered as providing any
preference for ASA in a competitive carrier selection proceeding to
determine which carrier(s) should be entitled to use the authority at
issue.

The code-share operations conducted under this authorization are subject
to the following conditions:

The code-share operations conducted under this authority must comply
with 14 CFR 257 and with any amendment to the Department’s regulations
concerning code-share arrangements that may be adopted.  Notwithstanding
any provisions in the contract between the carriers, our approval here
is expressly conditioned upon the requirements that the subject foreign
air transportation be sold in the name of the carrier holding out such
service in computer reservation systems and elsewhere; that the carrier
selling such transportation (i.e., the carrier shown on the ticket)
accept responsibility for the entirety of the code-share journey for all
obligations established in its contract of carriage with the passenger;
and that the passenger liability of the operating carrier be unaffected.

The authority granted here is specifically conditioned so that neither
ASA nor its code-share partner(s) shall give any force and effect to any
contractual provisions between themselves that are contrary to these
conditions.

Remarks: The authority for which ASA requested renewal expired June 10,
2006, but has been kept in force pursuant to the provisions of the
Administrative Procedure Act, 5 U.S.C. 558(c), as implemented by 14 CFR
Part 377, pending action on its timely-filed renewal application.

________________________________________________________________________
_______________

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the exemption services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov

APPENDIX

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration, the Transportation Security Administration, and with all
applicable U.S. Government requirements concerning security, including,
but not limited to, 49 CFR Part 1544.  To assure compliance with all
applicable U.S. Government requirements concerning security, the holder
shall, before commencing any new service (including charter flights) to
or from a foreign airport, contact its International Principal Security
Inspector (IPSI) to advise the IPSI of its plans and to find out whether
the Transportation Security Administration has determined that security
is adequate to allow such airport(s) to be served;

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

			11/2006

 PAGE


(Comment 32) Some comments claim that ECT devices for specific
intended uses are being reclassified for financial reasons and the
Agency was influenced by the pharmaceutical industry in making its
determination. A comment also asked FDA to provide reparations for ECT
patients.
    (Response 32) As stated previously in this section, FDA based its
determination of reclassification of ECT devices for use in treating
catatonia or a severe MDE associated with MDD or BPD to class II
(special controls) on valid scientific evidence, including the

classification panel recommendations, evaluation of scientific
literature, clinical practice guidelines, and comments submitted to the
ECT public dockets. These comments and the request for reparations are
outside the scope of this final order.
    (Comment 33) A comment claimed that there is discriminatory use of
ECT including in women, people of color, elderly, and economically
struggling patients. Another comment stated that many people are
receiving ECT treatment out of desperation.
    (Response 33) FDA understands the concerns of possible
discriminatory actions by sub-populations in the treatment of ECT and
possible treatment out of desperation; however, these comments are
outside the scope of this final order in determining the classification
of ECT devices.
    (Comment 34) A comment stated that the advertising of ECT devices
directed at consumers promotes ``risk-taking behavior.''
    (Response 34) This is also outside the scope of this final order in
determining the classification of ECT devices.
    Under the FD&C Act, FDA has regulatory authority over the labeling
of medical devices (21 CFR part 801). However, FDA's regulation of
medical device advertising is limited to a subset of restricted medical
devices, which ECT is not. The Federal Trade Commission regulates the
advertising, as opposed to the labeling, of most medical devices under
sections 12-15 of the Federal Trade Commission Act, which prohibit
false or misleading advertising of certain products that FDA regulates
(15 U.S.C. 52-55).

IV. The Final Order

    Under section 515(b) and (i) of the FD&C Act, FDA is adopting, in
part, its findings as published in the preamble to the proposed order.
For the reasons described previously in section II, FDA has made
revisions in this final order in response to comments submitted in the
ECT public dockets and information received on the proposed order. The
revisions modify the ECT class II classification to also reclassify ECT
devices used for the treatment of catatonia into class II. The
revisions further modify the ECT class II classification by changing
the requirement that the patient be ``18 years of age and older'' to
the requirement that the patient be ``age 13 years and older.'' The
revisions modify the ECT class III classification by removing the
catatonia intended use.
    In response to comments, FDA also made some changes to the patient
labeling special control requirement that addresses statements on the
physical risks of ECT and additional age-related precautions. The
patient labeling provides a list of physical risks, including pulmonary
(affecting lungs) complications. FDA removes ``insufficient or lack of
breathing'' as a pulmonary complication and revised the complication
list to include potential pulmonary complications of general anesthesia
and neuromuscular blocking agents (muscle relaxants) given as part of
ECT. FDA added language to clarify that the pulmonary risks of ECT
include hypoxemia, hypoventilation, aspiration, and upper-airway
obstruction (see Sec.  882.5940(b)(1)(ix)(H)(3)(v)).
    FDA separately considered the risk of the accessory electrodes as
part of this classification (see Sec.  882.5940(b)(1)(iii)). No other
accessories are considered part of this classification.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k), if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the SE of the device. For these ECT
devices classified as class II, FDA has determined that premarket
notification is necessary to provide reasonable assurance of the SE of
the device. Therefore, this device type is not exempt from premarket
notification requirements. Persons who intend to market this type of
device must submit to FDA a premarket notification, prior to marketing
the device, which contains information about the device they intend to
market.
    Under section 515(i)(2) of the FD&C Act, FDA has the authority to
issue an administrative order revising the classification of a device
for which FDA has classified as a class III device and for which no
administrative order has been issued calling for PMAs under section
515(b) of the FD&C Act, so that the device is classified into class I
or class II, after issuance of a proposed order, a meeting of a device
classification panel, and consideration of the comments on a proposed
order.
    FDA published a proposed order to require the reclassification of
ECT devices for intended uses specified in the proposed order and to
require the filing of a PMA for ECT devices for other intended uses
specified in the proposed order in the Federal Register of December 29,
2015. Moreover, as explained in section II of the proposed order, on
January 27-28, 2011, FDA held a classification meeting of the 2011
Panel to discuss classification of ECT devices for treatment of several
disorders. FDA received and has considered all the comments received in
response to all the ECT public dockets, including the proposed order,
as discussed in section II. Therefore, FDA has met the requirements
under sections 515(b)(1) and 515(i)(2) of the FD&C Act.

V. Implementation Strategy

A. Date To File a PMA

    In accordance with section 515(b) of the FD&C Act, ECT devices
indicated for schizophrenia, bipolar manic states, schizoaffective
disorder, schizophreniform disorder, and catatonia or a severe MDE
associated with MDD or BPD in patients under 13 years who are
treatment-resistant or who require a rapid response due to the severity
of their psychiatric or medical condition must have a PMA or a notice
of completion of a PDP filed with the Agency by March 26, 2019. An
applicant whose device was legally in commercial distribution before
May 28, 1976, or whose device has been found to be substantially
equivalent to such a device, will be permitted to continue marketing
such class III devices during FDA's review of the PMA provided that the
PMA is timely filed. FDA intends to review any PMA for the device
within 180 days of the date of filing. FDA cautions that under section
515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an
agreement to extend the review period for a PMA beyond 180 days unless
the Agency finds that ``the continued availability of the device is
necessary for the public health.''
    Under Sec.  [thinsp]812.2(d) (21 CFR 812.2(d)), the exemptions from
the requirements of the IDE regulations for preamendments class III
devices in Sec.  [thinsp]812.2(c)(1) and (2) will cease to apply to ECT
devices indicated for schizophrenia, bipolar manic states,
schizoaffective disorder, schizophreniform disorder, and catatonia or a
severe MDE associated with MDD or BPD in patients that are under 13
years, or patients of any age who are not treatment-resistant or who do
not require a rapid response due to the severity of their psychiatric
or medical condition that are: (1) Not legally on the market on or
before March 26, 2019 or (2) legally on the market on or before March
26, 2019 but for which a PMA or notice of completion of a PDP is not
filed by March 26, 2019, or for which PMA approval has been denied or
withdrawn.
    If a PMA for a class III device is not filed with FDA by March 26,
2019, the device will be deemed adulterated under section 501(f) of the
FD&C Act. The device may be distributed for

investigational use only if the requirements of the IDE regulations are
met. The requirements for significant risk devices include submitting
an IDE application to FDA for its review and approval. An approved IDE
is required to be in effect before an investigation of the device may
be initiated or continued under Sec.  [thinsp]812.30. FDA, therefore,
cautions that IDE applications should be submitted to FDA at least 30
days before March 26, 2019 to avoid interrupting investigations.

B. Compliance With Special Controls

    Following the effective date of this final order, ECT devices
intended for use in treating catatonia or a severe MDE associated with
MDD or BPD in patients age 13 years and older who are treatment-
resistant or who require a rapid response due to the severity of their
psychiatric or medical condition must comply with the special controls.
FDA notes that a firm whose ECT device was legally in commercial
distribution before May 28, 1976, or whose device was found to be
substantially equivalent to such a device and who does not intend to
market such device for uses other than use in treating catatonia or a
severe MDE associated with MDD or BPD in patients age 13 years and
older who are treatment-resistant or who require a rapid response due
to the severity of their psychiatric or medical condition, may remove
such intended uses from the device's labeling.
    The special controls identified in this final order are effective
as of the date of publication of this order, December 26, 2018. ECT
devices intended for use in treating catatonia or a severe MDE
associated with MDD or BPD in patients age 13 years and older who are
treatment-resistant or who require a rapid response due to the severity
of their psychiatric or medical condition must comply with the special
controls following the effective date of this order. Manufacturers who
wish to continue to legally market an ECT device for treatment of
catatonia or a severe MDE associated with MDD or BPD in patients age 13
years and older who are treatment-resistant or who require a rapid
response due to the severity of their psychiatric or medical condition
must submit an amendment to their previously cleared 510(k) that
demonstrates compliance with the special controls by June 24, 2019.
Because FDA has modified the class II indications and the class II
patient population from the proposed order, FDA is extending the time
period for submitting an amendment to the 510(k), from 60 days to 180
days, to provide additional preparation time to submit a 510(k)
amendment. Such amendment will be added to the 510(k) file but will not
serve as a basis for a new substantial equivalence review. A submitted
510(k) amendment in this context will be used solely to demonstrate to
FDA that an ECT device is in compliance with the special controls. If a
510(k) amendment is not submitted by June 24, 2019 or if FDA determines
that the amendment does not demonstrate compliance with the special
controls, the device may be considered adulterated under section
501(f)(1)(B) of the FD&C Act.
    For ECT devices that are not in class III as designated in this
final order, that have not been legally marketed prior to December 26,
2018, or models that have been legally marketed but are required to
submit a new 510(k) under 21 CFR 807.81(a)(3) because the device is
about to be significantly changed or modified, manufacturers must
obtain 510(k) clearance, among other relevant requirements, and
demonstrate compliance with the special controls included in this final
order, before marketing the new or changed device.

VI. Codification of Orders

    Section 515(b), as amended by FDASIA, and 515(i)(2) of the FD&C Act
require FDA to issue final orders rather than regulations to reclassify
devices. Therefore, FDA will continue to codify reclassifications and
requirements for approval of an application for premarket approval,
resulting from changes issued in final orders, in the Code of Federal
Regulations. Accordingly, under section 515(i)(2) of the FD&C Act, as
amended by FDASIA, in this final order, we are codifying the
reclassification of ECT devices for use in treating catatonia or a MDE
associated with MDD or BPD in patients age 13 years and older who are
treatment-resistant or who require a rapid response due to the severity
of their psychiatric or medical condition into class II by amending
Sec.  882.5940. Further, we are codifying the requirement for approval
of an application for premarket approval for ECT devices for the
intended uses of schizophrenia, bipolar manic states, schizoaffective
disorder, schizophreniform, and catatonia or a severe major depressive
episode associated with MDD or BPD in patients under 13 years, or
patients 13 years and older who are not treatment-resistant or who do
not require a rapid response due to the severity of their psychiatric
or medical condition, by amending the language in Sec.  882.5940.

VII. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) 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.

VIII. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3520). The collections of information in part 807, subpart E, have
been approved under OMB control number 0910-0120. The collections of
information in part 812 have been approved under OMB control number
0910-0078. The collections of information in 21 CFR part 814 have been
approved under OMB control number 0910-0231. The collections of
information in 21 CFR part 801 have been approved under OMB control
number 0910-0485.
    The device and patient warning labeling provisions in this final
order are not subject to review by OMB because they do not constitute a
``collection of information'' under the PRA. Rather, the recommended
labeling is a ``public disclosure of information originally supplied by
the Federal government to the recipient for the purpose of disclosure
to the public'' (5 CFR 1320.3(c)(2)).

IX. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 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.

* 1. FDA, ``Medical Device Accessories--Describing Accessories and
Classification Pathways; Guidance for Industry and Food and Drug
Administration Staff.'' December 20, 2017.
* 2. FDA, ``Reclassification of Daily Wear Spherical Contact Lenses
Consisting of Rigid Gas Permeable Plastic Materials;

Withdrawal of Proposed Rule.'' 48 FR 56778.
* 3. FDA, ``Use of Real-World Evidence to Support Regulatory
Decision-Making for Medical Devices; Guidance for Industry and Food
and Druge Administration Staff.'' August 31, 2017.
* 4. FDA, ``FDA Executive Summary, Prepared for the January 27-28,
2011, meeting of the Neurological Devices Panel, Meeting to Discuss
the Classification of Electroconvulsive Therapy Devices (ECT).''
2011.
5. Fernie, G., et al., ``Detecting Objective and Subjective
Cognitive Effects of Electroconvulsive Therapy: Intensity, Duration
and Test Utility in a Large Clinical Sample.'' Psychological
Medicine, 2014. 44(14): pp. 2985-2994.
6. Kirov, G.G., et al., ``Evaluation of Cumulative Cognitive
Deficits from Electroconvulsive Therapy.'' British Journal of
Psychiatry, 2016. 208(3): pp. 266-270.
7. Maric, N.P., et al., ``The Acute and Medium-Term Effects of
Treatment with Electroconvulsive Therapy on Memory in Patients with
Major Depressive Disorder.'' Psychological Medicine, 2016. 46(4):
pp. 797-806.
8. Spaans, H.P., et al., ``Efficacy and Cognitive Side Effects After
Brief Pulse and Ultrabrief Pulse Right Unilateral Electroconvulsive
Therapy for Major Depression: A Randomized, Double-Blind, Controlled
Study.'' Journal of Clinical Psychiatry, 2013. 74(11): pp. e1029-
1036.
9. Semkovska, M., et al., ``Bitemporal Versus High-Dose Unilateral
Twice-Weekly Electroconvulsive Therapy for Depression (EFFECT-Dep):
A Pragmatic, Randomized, Non-Inferiority Trial.'' American Journal
of Psychiatry, 2016. 173(4): pp. 408-417.
10. Ghaziuddin, N., et al., ``Cognitive Side Effects of
Electroconvulsive Therapy in Adolescents.'' Journal of Child
Adolescent Psychopharmacology, 2000. 10(4): pp. 269-276.
11. Dessens, F.M., et al., ``Electroconvulsive Therapy in the
Intensive Care Unit for the Treatment of Catatonia: A Case Series
and Review of the Literature.'' General Hospital Psychiatry, 2016.
38: pp. 37-41.
12. England, M.L., et al., ``Catatonia in Psychotic Patients:
Clinical Features and Treatment Response.'' Journal of
Neuropsychiatry and Clinical Neurosciences, 2011. 23(2): pp. 223-
226.
13. Faedda, G.L., et al., ``Catatonia in an Adolescent with Velo-
Cardio-Facial Syndrome.'' American Journal of Medical Genetics Part
A, 2015. 167A(9): pp. 2150-2153.
14. Flamarique, I., et al., ``Long-Term Effectiveness of
Electroconvulsive Therapy in Adolescents with Schizophrenia Spectrum
Disorders.'' European Child and Adolescent Psychiatry, 2015. 24(5):
pp. 517-524.
15. Ghaziuddin, N., et al., ``Retrospective Chart Review of
Catatonia in Child and Adolescent Psychiatric Patients.'' Acta
Psychiatrica Scandinavia, 2012. 125(1): pp. 33-38.
16. Haq, A.U. and N. Ghaziuddin, ``Maintenance Electroconvulsive
Therapy for Aggression and Self-Injurious Behavior in Two
Adolescents with Autism and Catatonia.'' Journal of Neuropsychiatry
and Clinical Neurosciences, 2014. 26(1): pp. 64-72.
17. Jacob, P., et al., ``Review of Electroconvulsive Therapy
Practice from a Tertiary Child and Adolescent Psychiatry Centre.''
Asian Journal of Psychiatry, 2014. 12: pp. 95-99.
18. Luchini, F., et al., ``Electroconvulsive Therapy in Catatonic
Patients: Efficacy and Predictors of Response.'' World Journal of
Psychiatry, 2015. 5(2): pp. 182-192.
19. Medda, P., et al., ``Catatonia in 26 Patients with Bipolar
Disorder: Clinical Features and Response to Electroconvulsive
Therapy.'' Bipolar Disorders, 2015. 17(8): pp. 892-901.
20. Medda, P., et al., ``Electroconvulsive Therapy in 197 Patients
with a Severe, Drug-Resistant Bipolar Mixed State: Treatment Outcome
and Predictors of Response.'' Journal of Clinical Psychiatry, 2015.
76(9): pp. 1168-1173.
21. Raffin, M., et al., ``Treatment Use in a Prospective
Naturalistic Cohort of Children and Adolescents with Catatonia.''
European Child and Adolescent Psychiatry, 2015. 24(4): pp. 441-449.
22. Raveendranathan, D., et al., ``Response Rate of Catatonia to
Electroconvulsive Therapy and its Clinical Correlates.'' European
Archives of Psychiatry and Clinical Neurosciences, 2012. 262(5): pp.
425-430.
23. Shelef, A., et al., ``Acute Electroconvulsive Therapy Followed
by Maintenance Electroconvulsive Therapy Decreases Hospital Re-
Admission Rates of Older Patients with Severe Mental Illness.''
Journal of ECT, 2015. 31(2): pp. 125-128.
24. Sienaert, P., et al., ``A Clinical Review of the Treatment of
Catatonia.'' Frontiers in Psychiatry, 2014. 5: p. 181.
25. Unal, A., et al., ``Effective Treatment of Catatonia by
Combination of Benzodiazepine and Electroconvulsive Therapy.''
Journal of ECT, 2013. 29(3): pp. 206-269.
26. Hasan, A., et al., ``World Federation of Societies of Biological
Psychiatry (WFSBP) Guidelines for Biological Treatment of
Schizophrenia, Part 1: Update 2012 on the Acute Treatment of
Schizophrenia and the Management of Treatment Resistance.'' World
Journal of Biologial Psychiatry, 2012. 13(5): pp. 318-378.
27. Ghaziuddin, N., et al., ``Use of Continuation or Maintenance
Electroconvulsive Therapy in Adolescents with Severe Treatment-
Resistant Depression.'' Journal of ECT, 2011. 27(2): pp. 168-174.
28. Lima, N.N., et al., ``Electroconvulsive Therapy Use in
Adolescents: A Systematic Review.'' Annals of General Psychiatry,
2013. 12(1): p. 17.
29. Puffer, C.C., et al., ``A 20 Year Practice Review of
Electroconvulsive Therapy for Adolescents.'' Journal of Child and
Adolescent Psychopharmacology, 2016. 26(7): pp. 632-636.
30. de la Serna, E., et al., ``Two-Year Follow-Up of Cognitive
Functions in Schizophrenia Spectrum Disorders of Adolescent Patients
Treated with Electroconvulsive Therapy.'' Journal of Child and
Adolescent Psychopharmacology, 2011. 21(6): pp. 611-619.
31. Zhang, Z.J., et al., ``Electroconvulsive therapy improves
antipsychotic and somnographic responses in adolescents with first-
episode psychosis--a case-control study.'' Schizophrenia Research,
2012. 137(1-3): pp. 97-103.
32. Cohen, D., et al., ``Absence of Cognitive Impairment at Long-
Term Follow-Up in Adolescents Treated with ECT for Severe Mood
Disorder.'' American Journal of Psychiatry, 2000. 157(3): pp. 460-
462.
33. Consoli, A., et al., ``Electroconvulsive Therapy in Adolescents
with the Catatonia Syndrome: Efficacy and Ethics.'' Journal of ECT,
2010. 26(4): pp. 259-265.
34. Rey, J.M. and G. Walter, ``Half a Century of ECT Use in Young
People.'' American Journal of Psychiatry, 1997. 154(5): pp. 595-602.
35. Walter, G. and J.M. Rey, ``An Epidemiological Study of the Use
of ECT in Adolescents.'' Journal of the American Academy of Child
and Adolescent Psychiatry, 1997. 36(6): p. 809-15.
36. Ghaziuddin, N., et al., ``Electroconvulsive Treatment in
Adolescents with Pharmacotherapy-Refractory Depression.'' Journal of
Child and Adolescent Psychopharmacology, 1996. 6(4): pp. 259-271.
37. Strober, M., et al., ``Effects of Electroconvulsive Therapy in
Adolescents with Severe Endogenous Depression Resistant to
Pharmacotherapy.'' Biological Psychiatry, 1998. 43(5): pp. 335-358.
38. Cohen, D., et al., ``Use of Electroconvulsive Therapy in
Adolescents.'' Convulsion Therapy, 1997. 13(1): pp. 25-31.
39. Kutcher, S.R. and H.A. Robertson, ``Electroconvulsive Therapy in
Treatment-Resistant Bipolar Youth.'' Journal of Child and Adolescent
Psychopharmacology, 1995. 5: pp. 167-175.
40. Ghaziuddin, N., et al., ``Practice Parameter for Use of
Electroconvulsive Therapy with Adolescents.'' Journal of the
American Academy of Child and Adolescent Psychiatry, 2004. 43(12):
pp. 1521-1539.
* 41. FDA, Transcript of January 27-28, 2011, Meeting of the
Neurological Devices Panel, Meeting to Discuss the Classification of
Electroconvulsive Therapy Devices (ECT). 2011.
42. Baeza, I., et al., ``Clinical Experience Using Electroconvulsive
Therapy in Adolescents with Schizophrenia Spectrum Disorders.''
Journal of Child and Adolescent Psychopharmacology, 2010. 20(3): pp.
205-259.
43. Benzoni, O., et al., ``Treatment of Resistant Mood and
Schizoaffective

Disorders With Electroconvulsive Therapy: A Case Series of 264
Patients.'' Journal of Psychopathology, 2015. 21: pp. 266-268.
44. Iancu, I., et al., ``Patients with Schizophrenia or
Schizoaffective Disorder Who Receive Multiple Electroconvulsive
Therapy Sessions: Characteristics, Indications, and Results.''
Neuropsychiatric Disease and Treatment, 2015. 11: pp. 853-862.
45. Kristensen, D., et al., ``Electroconvulsive Therapy for Treating
Schizophrenia: A Chart Review of Patients from Two Catchment
Areas.'' European Archive of Psychiatry and Clinical Neurosciences,
2011. 261(6): pp. 425-432.
46. Levy-Rueff, M., et al., ``Maintenance Electroconvulsive Therapy:
An Alternative Treatment for Refractory Schizophrenia and
Schizoaffective Disorders.'' Psychiatry Research, 2010. 175(3): pp.
280-283.
47. Petrides, G., et al., ``Electroconvulsive Therapy Augmentation
in Clozapine-Resistant Schizophrenia: A Prospective, Randomized
Study.'' American Journal of Psychiatry, 2015. 172(1): pp. 52-58.
48. Lehman, A.F., et al., ``Practice Guideline for the Treatment of
Patients with Cchizophrenia,'' Second Edition. American Journal of
Psychiatry, 2004. 161(2 Suppl): pp. 1-56.
49. Black, D.W., et al., ``ECT in Unipolar and Bipolar Disorders: A
Naturalistic Evaluation of 460 Patients.'' Convulsion Therapy, 1986.
2(4): pp. 231-237.
50. Mukherjee, S., et al., ``Unmodified Electroconvulsive Therapy of
Acute Mania: A Retrospective Naturalistic Study.'' Convulsion
Therapy, 1992. 8(1): pp. 5-11.
51. Small, J.G., et al., ``Electroconvulsive Treatment Compared with
Lithium in the Management of Manic States.'' Archives of General
Psychiatry, 1988. 45(8): pp. 727-732.
52. Milstein, V., et al., ``Does Electroconvulsive Therapy Prevent
Suicide?'' Convulsion Therapy, 1986. 2(1): pp. 3-6.
* 53. United Nations General Assembly, ``Interim Report of the
Special Rapporteur on Torture and Other Cruel, Inhuman or Degrading
Treatment or Punishment.'' 2008.
* 54. U.S. Department of Health and Human Services. ``Mental Health:
A Report of the Surgeon General.'' Rockville, MD: U.S. Department of
Health and Human Services, Substance Abuse and Mental Health
Services Administration, Center for Mental Health Services, National
Institutes of Health, National Institute of Mental Health, 1999.
(See https://profiles.nlm.nih.gov/ps/access/NNBBHS.pdf)
* 55. Texas Department of State Health Services, ``Electroconvulsive
Therapy (ECT) Reports.'' 2018.
* 56. FDA, ``MedWatch: The FDA Safety Information and Adverse Event
Reporting Program.''
** 57. FDA, ``Neurological Devices Panel--ECT,'' January 2011, 24
Hour Summary. 2011.
58. Brown, E.D., et al., ``Efficacy of Continuation/Maintenance
Electroconvulsive Therapy for the Prevention of Recurrence of a
Major Depressive Episode in Adults with Unipolar Depression: A
Systematic Review.'' Journal of ECT, 2014. 30(3): pp. 195-202.
59. de Sousa, R.T., et al., ``Challenging Treatment-Resistant Major
Depressive Disorder: A Roadmap for Improved Therapeutics.'' Current
Neuropharmacology, 2015. 13(5): pp. 616-635.
60. Tor, P.C., et al., ``A Systematic Review and Meta-Analysis of
Brief Versus Ultrabrief Right Unilateral Electroconvulsive Therapy
for Depression.'' Journal of Clinical Psychiatry, 2015. 76(9): pp.
e1092-1098.
61. American Psychiatric Association, ``Diagnostic and Statistical
Manual of Mental Disorders,'' Fifth Edition, DSM-5. 2013.
** 62. FDA, ``Device Labeling Guidance #G91-1 (Blue Book Memo).''
1991.

List of Subjects in 21 CFR Part 882

    Medical devices, Neurological devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

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

0
2. Revise Sec.  882.5940 to read as follows:

Sec.  882.5940   Electroconvulsive therapy device.

    (a) Identification. An electroconvulsive therapy device is a
prescription device, including the pulse generator and its stimulation
electrodes, used for treating severe psychiatric disturbances by
inducing in the patient a major motor seizure by applying a brief
intense electrical current to the patient's head.
    (b) Classification. (1) Class II (special controls) when the device
is intended to treat catatonia or a severe major depressive episode
(MDE) associated with major depressive disorder (MDD) or bipolar
disorder (BPD) in patients age 13 years and older who are treatment-
resistant or who require a rapid response due to the severity of their
psychiatric or medical condition. The special controls for this device
are:
    (i) The technical parameters of the device, including waveform,
output mode, pulse duration, frequency, train delivery, maximum charge
and energy, and the type of impedance monitoring system must be fully
characterized to ensure that the device performance characteristics are
consistent with existing clinical performance data.
    (ii) Non-clinical testing data must confirm the electrical
characteristics of the output waveform.
    (iii) Components of the device that come into human contact must be
demonstrated to be biocompatible.
    (iv) Performance data must demonstrate electrical and mechanical
safety and the functioning of all safety features built into the device
including the static and dynamic impedance monitoring system.
    (v) Appropriate analysis/testing must validate electromagnetic
compatibility.
    (vi) Appropriate software verification, validation, and hazard
analysis must be performed.
    (vii) Performance data must demonstrate electrical performance,
adhesive integrity, and physical and chemical stability of the
stimulation electrodes.
    (viii) The labeling for the device must include the following:
    (A) Information related to generic adverse events associated with
electroconvulsive therapy device (ECT) treatment;
    (B) Instructions must contain the following specific
recommendations to the user of the device:
    (1) Conduct of pre-ECT medical and psychiatric assessment
(including pertinent medical and psychiatric history, physical
examination, anesthesia assessment, dental assessment, and other
studies as clinically appropriate);
    (2) Use of patient monitoring during the procedure;
    (3) Use of general anesthesia and neuromuscular blocking agents;
    (4) Use of mouth/dental protection during the procedure;
    (5) Use of EEG monitoring until seizure termination;
    (6) Instructions on electrode placement, including adequate skin
preparation and use of conductive gel; and
    (7) Cognitive status monitoring prior to beginning ECT and during
the course of treatment via formal neuropsychological assessment for
evaluating specific cognitive functions (e.g., orientation, attention,
memory, executive function).
    (C) Clinical training needed by users of the device;
    (D) Information on the patient population in which the device is
intended to be used;
    (E) Information on how the device operates and the typical course
of treatment;

    (F) A detailed summary of the clinical testing, which includes the
clinical outcomes associated with the use of the device, and a summary
of adverse events and complications that occurred with the device;
    (G) A detailed summary of the device technical parameters;
    (H) Where appropriate, validated methods and instructions for
reprocessing of any reusable components;
    (I) The following statement, prominently placed: ``Warning: ECT
device use may be associated with: disorientation, confusion, and
memory problems''; and
    (J) Absent performance data demonstrating a beneficial effect of
longer term use, generally considered treatment in excess of 3 months,
the following statement, prominently placed: ``Warning: When used as
intended this device provides short-term relief of symptoms. The long-
term safety and effectiveness of ECT treatment has not been
demonstrated.''
    (ix) Patient labeling must be provided and include:
    (A) Relevant contraindications, warnings, precautions;
    (B) A summation of the clinical testing, which includes the
clinical outcomes associated with the use of the device, and a summary
of adverse events and complications that occurred with the device;
    (C) Information on how the device operates and the typical course
of treatment;
    (D) The potential benefits;
    (E) Alternative treatments;
    (F) The following statement, prominently placed: ``Warning: ECT
device use may be associated with: Disorientation, confusion, and
memory problems'';
    (G) Absent performance data demonstrating a beneficial effect of
longer term use, generally considered treatment in excess of 3 months,
the following statement, prominently placed: ``Warning: When used as
intended this device provides short-term relief of symptoms. The long-
term safety and effectiveness of ECT treatment has not been
demonstrated''; and
    (H) The following statements on known risks of ECT, absent
performance data demonstrating that these risks do not apply:
    (1) ECT treatment may be associated with disorientation, confusion
and memory loss, including short-term (anterograde) and long-term
(autobiographical) memory loss following treatment. Based on the
majority of clinical evidence, these side effects tend to go away
within a few days to a few months after the last treatment with ECT.
Although the incidence of permanent cognitive memory loss was not
supported by the clinical literature, some patients have reported a
permanent loss of memories of personal life events (i.e.,
autobiographical memory);
    (2) Patients treated with ECT may experience manic symptoms
(including euphoria and/or irritability, impulsivity, racing thoughts,
distractibility, grandiosity, increased activity, talkativeness, and
decreased need for sleep) or a worsening of the psychiatric symptoms
they are being treated for; and
    (3) The physical risks of ECT may include the following (in order
of frequency of occurrence):
    (i) Pain/somatic discomfort (including headache, muscle soreness,
and nausea);
    (ii) Skin burns;
    (iii) Physical trauma (including fractures, contusions, injury from
falls, dental and oral injury);
    (iv) Prolonged or delayed onset seizures;
    (v) Pulmonary complications (hypoxemia, hypoventilation,
aspiration, upper-airway obstruction);
    (vi) Cardiovascular complications (cardiac arrhythmias, heart
attack, high or low blood pressure, and stroke); and
    (vii) Death.
    (2) Classification: Class III (premarket approval) for the
following intended uses: schizophrenia, bipolar manic states,
schizoaffective disorder, schizophreniform disorder, and catatonia or a
severe MDE associated with MDD or BPD in:
    (i) Patients under 13 years or
    (ii) Patients 13 years and older who are not treatment-resistant or
who do not require a rapid response due to the severity of their
psychiatric or medical condition.
    (c) Date premarket approval application (PMA) or notice of
completion of product development protocol (PDP) is required. A PMA or
notice of completion of a PDP is required to be filed with FDA on or
before March 26, 2019, for any electroconvulsive therapy device with an
intended use described in paragraph (b)(2) of this section, that was in
commercial distribution before May 28, 1976, or that has, on or before
March 26, 2019, been found to be substantially equivalent to any
electroconvulsive therapy device with an intended use described in
paragraph (b)(2) of this section, that was in commercial distribution
before May 28, 1976. Any other electroconvulsive therapy device with an
intended use described in paragraph (b)(2) of this section shall have
an approved PMA or declared completed PDP in effect before being placed
in commercial distribution.

    Dated: December 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27809 Filed 12-21-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 104 (Wednesday, June 2, 2021)]
[Notices]
[Page 29573]
[FR Doc No: 2021-11556]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD20-9-000]

Hybrid Resources; Notice Inviting Comments

    On January 19, 2021, the Federal Energy Regulatory Commission
(Commission) directed each Regional Transmission Organization and
Independent System Operator (RTO/ISO) to submit informational reports
by July 19, 2021 regarding hybrid resource issues, with public comments
due 30 days thereafter (August 18, 2021).\1\ Concurrently with the
issuance of this notice, the Commission is issuing a staff white paper
on Hybrid Resources. The white paper discusses the Hybrid Resources
technical conference held by the Commission in July 2020 in this
proceeding, as well as the information learned in post-technical
conference comments.\2\ Pursuant to this notice, all interested persons
are invited to submit comments on the white paper, including
information pertaining to non-RTO/ISO regions. We encourage commenters
to jointly respond to both the white paper and RTO/ISO informational
reports where applicable to avoid duplicate comments. Comments on both
the RTO/ISO informational reports and the white paper are due August
18, 2021, 30 days after the RTO/ISO hybrid resource informational
reports are filed.
---------------------------------------------------------------------------

    \1\ Hybrid Resources, 174 FERC ] 61,034 (2021).
    \2\ See Hybrid Resources, Notice Inviting Post-Technical
Conference Comments, Docket No. AD20-9-000 (Aug. 10, 2020).
---------------------------------------------------------------------------

    For more information about this Notice, please contact:

Kaitlin Johnson (Technical Information), Office of Energy Policy and
Innovation, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>Meghan O'Brien (Legal Information), Office of the General Counsel,
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
exception occurred on : 2021-11556.htm
exception occurred on : 2021-11556.htm
DC 20426,<PHONE_NUMBER>, Meghan.O'[email protected].

    Dated: May 26, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-11556 Filed 6-1-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Proposed Rules]
[Pages 3236-3238]
[FR Doc No: 2022-00994]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-1003; Project Identifier MCAI-2020-00962-A]
RIN 2120-AA64

Airworthiness Directives; Viking Air Limited (Type Certificate
Previously Held by Bombardier Inc. and de Havilland, Inc.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Viking Air Limited (Viking) (type certificate previously held
by Bombardier Inc. and de Havilland, Inc.) Model DHC-6-1, DHC-6-100,
DHC-6-200, DHC-6-300, and DHC-6-400 airplanes. This proposed AD results
from mandatory continuing airworthiness information (MCAI) originated
by an aviation authority of another country to identify and correct an
unsafe condition on an aviation product. The MCAI identifies the unsafe
condition as cracks and corrosion damage to the aileron internal
structure. This proposed AD would require visually inspecting the
entire aileron internal structure, correcting any damage found, and
reporting the inspection results to Viking. The FAA is proposing this
AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by March 7,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12 140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Viking Air
Ltd., 1959 de Havilland Way, Sidney British Columbia, Canada V8L 5V5;
phone:<PHONE_NUMBER>; email: [email protected];
website: https://www.vikingair.com. You may view this service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 901 Locust, Kansas City, MO 64106. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-1003; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the MCAI,
any comments received, and other information. The street address for
Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Deep Gaurav, Aviation Safety Engineer,
New York ACO Branch, FAA, 1515 Stewart Avenue, Westbury, NY 11590;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2020-1003; Project Identifier
MCAI-2020-00962-A'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Deep
Gaurav, Aviation Safety Engineer, New York ACO Branch, FAA, 1515
Stewart Avenue, Westbury, NY 11590. Any commentary that the FAA
receives which is not specifically designated as CBI will be placed in
the public docket for this rulemaking.

Background

    Transport Canada, which is the aviation authority for Canada, has
issued Transport Canada AD CF-2020-05, dated March 13, 2020 (referred
to after this as ``the MCAI''), to address the unsafe condition on
Viking Model DHC-6 series 1, DHC-6 series 100, DHC-6 series 110, DHC-6
series 200, DHC-6 series 210, DHC-6 series 300, DHC-6 series 310, DHC-6
series 320, and DHC-6 series 400 airplanes. The MCAI states:

    Viking Air Ltd. (Viking) received reports of cracks and
corrosion damage to the aileron internal structure. During a repair
of an in-service aeroplane, an aileron hinge support rib was found
cracked at the lower flange along the bend radius near the hinge
fitting attachment at wing station 247.29. Preliminary investigation
by Viking

determined that the observed crack was the result of fatigue. During
an inspection of another in-service aeroplane, the aileron inboard
rib and the vertical flange of the inboard aileron forward spar near
a fastener hole were also found cracked.
    The current inspection requirements of the affected aeroplanes
do not include a direct inspection of the aileron internal
structure. Cracks or other damage to the aileron ribs or to the
aileron spar flanges are not detectable from the aileron exterior
surfaces. Undetected cracks or other damage to the aileron internal
structure could lead to progressive looseness of the aileron at the
hinge support rib push-pull rod attachment and subsequent flutter
condition and degraded or loss of aileron control.
    To detect and correct any cracking or other damage to the
aileron internal structure, this [Transport Canada] AD mandates a
one-time Special Detailed Inspection (SDI) of all aileron internal
structure, including front and rear spars, all aileron ribs and
upper and lower skins for cracks, corrosion or other damage, and
rectification, as required, of the damaged parts.
    This [Transport Canada] AD also mandates reporting of all
inspection results to Viking. The reporting of the inspection
results is necessary to assess the overall aileron internal
structural condition on in-service aeroplanes and to determine
additional corrective action based on the results of the
inspections.
    Viking has published Service Bulletin (SB) V6/0066 Revision A,
dated 9 December 2019, (referred to as ``the SB'' in this AD)
providing accomplishment instructions for the inspection,
rectification of the damaged parts, and reporting requirements.

    You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
1003.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Viking DHC-6 Twin Otter Service Bulletin V6/0066,
Revision A, dated December 9, 2019. The service information specifies
procedures for visually inspecting the entire aileron internal
structure, including front and rear spars, all aileron ribs, and upper
and lower skins; repairing or replacing any damaged part; and reporting
inspection results to Viking Air Limited technical support. This
service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Other Related Service Information

    The FAA reviewed Viking DHC-6 Twin Otter Service Bulletin V6/0066,
Revision NC, dated August 29, 2019. The service information specifies
procedures for visually inspecting the aileron ribs, including ribs and
both sides of the hinge arm; repairing or replacing any damaged part;
and reporting inspection results to Viking Air Limited technical
support.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with this State of Design Authority,
it has notified the FAA of the unsafe condition described in the MCAI
and service information referenced above. The FAA is issuing this NPRM
after determining the unsafe condition described previously is likely
to exist or develop in other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in the service information described previously.

Interim Action

    The FAA considers that this proposed AD would be an interim action.
The inspection reports will provide the FAA and Viking Air Limited
additional data for determining the damage present in the fleet. After
analyzing the data, the FAA may take further rulemaking action.

Differences Between This Proposed AD and the MCAI

    The MCAI applies to Viking Air Limited Model DHC-6 series 110, DHC-
6 series 210, DHC-6 series 310, and DHC-6 series 320, and this proposed
AD would not because these models do not have an FAA type certificate.
Transport Canada Model DHC-6 series 1, DHC-6 series 100, DHC-6 series
200, DHC-6 series 300, and DHC-6 series 400 airplanes correspond to FAA
Model DHC-6-1, DHC-6-100, DHC-6-200, DHC-6-300, and DHC-6-400
airplanes, respectively.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 33 airplanes of U.S. registry. The FAA also estimates that it
would take about 3 work-hours per airplane to comply with the
inspection and 1 hour to comply with the reporting requirement of this
proposed AD. The average labor rate is $85 per work-hour.
    Based on these figures, the FAA estimates the cost of the proposed
AD on U.S. operators would be $11,220 or $340 per airplane.
    In addition, the FAA estimates that any necessary follow-on actions
to replace an aileron would take 6 work-hours and require parts costing
$52,243, for a cost of $52,753 per airplane. The FAA has no way of
determining the number of airplanes that may need these actions.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a currently valid OMB Control Number. The OMB
Control Number for this information collection is 2120-0056. Public
reporting for this collection of information is estimated to take
approximately 1 hour per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden to: Information Collection
Clearance Officer, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177-1524.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order

13132. This proposed AD would not have a substantial direct effect 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.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

Viking Air Limited (Type Certificate Previously Held by Bombardier
Inc. and de Havilland, Inc.): Docket No. FAA-2020-1003; Project
Identifier MCAI-2020-00962-A.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by March 7, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Viking Air Limited (type certificate
previously held by Bombardier Inc. and de Havilland, Inc.) Model
DHC-6-1, DHC-6-100, DHC-6-200, DHC-6-300, and DHC-6-400 airplanes,
all serial numbers, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 5700, Wing
Structure.

(e) Unsafe Condition

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI identifies the unsafe condition as cracks and
corrosion damage to the aileron internal structure. The FAA is
issuing this AD to detect and correct cracks and other damage to the
aileron internal structure. The unsafe condition, if not addressed,
could result in progressive looseness of the aileron at the hinge
support rib push-pull rod attachment, flutter condition, and
degraded or loss of aileron control, which could lead to loss of
control of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspection and Replacement of the Aileron

    At the compliance time specified in paragraph (g)(1) or (2) of
this AD, inspect the left-hand (LH) and right-hand (RH) aileron
internal structures for cracks, corrosion, and other damage and take
any necessary corrective actions in accordance with the
Accomplishment Instructions, steps II.A. through II.A.3. of Viking
DHC-6 Twin Otter Service Bulletin V6/0066, Revision A, dated
December 9, 2019 (Viking SB V6/0066, Revision A).
    (1) For each LH or RH aileron that has accumulated 16,000 or
more hours time-in-service (TIS), 32,000 or more flight cycles (FC),
or 10 or more years since first installation on an airplane,
whichever occurs first: Within 6 months after the effective date of
this AD.
    (2) For each LH or RH aileron that has accumulated less than
16,000 hours TIS, less than 32,000 FC, and less than 10 years since
first installation on an airplane: Within 6 months after
accumulating 16,000 hours TIS, 32,000 FC, or 10 years, whichever
occurs first.

(h) Reporting Requirement

    Within 30 days after the inspection required by paragraph (g)(1)
or (2) of this AD or within 30 days after the effective date of this
AD, whichever occurs later, report to Viking the information
requested on the Inspection Reply Form, page 7, of Viking SB V6/
0066, Revision A.

(i) Credit for Previous Actions

    You may take credit for the actions required by paragraphs
(g)(1) and (2) of this AD if you performed those actions before the
effective date of this AD using Viking DHC-6 Twin Otter Service
Bulletin V6/0066, Revision NC, dated August 29, 2019.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, New York ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (k)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    (1) For more information about this AD, contact Deep Gaurav,
Aviation Safety Engineer, New York ACO Branch, FAA, 1515 Stewart
Avenue, Westbury, NY 11590; phone:<PHONE_NUMBER>; fax: (516) 794-
5331; email: [email protected].
    (2) Refer to Transport Canada AD CF-2020-05, dated March 13,
2020, for more information. You may examine the Transport Canada AD
in the AD docket at https://www.regulations.gov by searching for and
locating Docket No. FAA-2020-1003.
    (3) For service information identified in this AD, contact
Viking Air Ltd., 1959 de Havilland Way, Sidney British Columbia,
Canada V8L 5V5; phone:<PHONE_NUMBER>; email:
[email protected]; website: https://www.vikingair.com. You may review this referenced service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 901 Locust, Kansas City, MO 64106. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued on January 13, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-00994 Filed 1-20-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 17 (Wednesday, January 26, 2011)]
[Notices]
[Page 4743]
[FR Doc No: 2011-1546]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection(s): NAS Data
Release Request

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on September 22, 2010, vol. 75, no. 183, page 57828. The
information enables the FAA to evaluate the validity of the user's
request for National Airspace (NAS) data from FAA systems and
equipment.

DATES: Written comments should be submitted by February 25, 2011.

FOR FURTHER INFORMATION CONTACT: Carla Scott on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0668.
    Title: NAS Data Release Request.
    Form Numbers: FAA Form 1200-5.
    Type of Review: Renewal of an information collection.
    Background: This data collection is the genesis for granting
approval to release filtered NAS data. The information provided sets
the criteria for the FAA Data Release Request Committee (DRRC) to
approve or disapprove individual requests for NAS data. The information
submitted by the requestor determines the requestor's eligibility to
use FAA NAS data. The agency currently uses the collected information
to determine suitability for procuring NAS data for use in various
evaluations.
    Respondents: Approximately 15 data requestors.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 3 hours.
    Estimated Total Annual Burden: 45 hours.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street, NW., Washington,
DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on January 19, 2011.
Carla Scott,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2011-1546 Filed 1-25-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Notices]
[Pages 22923-22925]
[FR Doc No: 2013-08924]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69362; File No. 600-23]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Notice of Filing of Amended Application for Registration as a Clearing
Agency

April 11, 2013.

I. Introduction

    On April 5, 2013, the Fixed Income Clearing Corporation (``FICC'')
filed with the Securities and Exchange Commission (``Commission'') an
amended Form CA-1 \1\ seeking permanent registration as a clearing
agency under Section 17A of the Securities Exchange Act of 1934 \2\
(``Act'') and Rule 17Ab2-1 thereunder.\3\ The Commission is publishing
this notice to solicit comments from interested persons regarding this
amended Form CA-1.\4\ The Commission will consider any comments it
receives in making its determination whether to grant FICC's request
for permanent registration as a clearing agency. The Commission will
grant FICC permanent registration only if it concludes that

FICC has satisfied all requirements of the Act.\5\
---------------------------------------------------------------------------

    \1\ See Letter from Donaldine Temple, Senior Associate Counsel
and Corporate Secretary, FICC, to Joseph P. Kamnik, Assistant
Director, Division of Trading and Markets (April 4, 2013). The
amendment filed by FICC updates all of the information required by
Form CA-1 and incorporates by reference all information submitted in
connection with FICC's prior application and amendments thereto, to
the extent this previously submitted information remains accurate.
    \2\ 15 U.S.C. 78q-1.
    \3\ 17 CFR 240.17Ab2-1(a).
    \4\ The descriptions set forth in this notice regarding the
structure and operations of FICC have been largely derived from
information contained in FICC's amended Form CA-1 application and
publicly available sources. The application and non-confidential
exhibits thereto are available on the Commission's Web site.
    \5\ See 15 U.S.C. 78q-1(b)(3).
---------------------------------------------------------------------------

II. Background

    On December 13, 1986, the Mortgage Backed Securities Clearing
Corporation (``MBSCC'') filed with the Commission a Form CA-1 \6\
seeking registration as a clearing agency. The Commission granted MBSCC
a temporary registration on February 2, 1987,\7\ and extended this
temporary registration on several occasions thereafter.\8\ On October
16, 1987, the Government Securities Clearing Corporation (``GSCC''),
filed with the Commission a Form CA-1 \9\ seeking registration as a
clearing agency. The Commission granted GSCC a temporary registration
on May 24, 1988,\10\ and extended this temporary registration on
several occasions thereafter.\11\ GSCC filed an amended Form CA-1 on
November 15, 2002, in which it explained that it intended to acquire
MBSCC.\12\ On January 1, 2003, GSCC acquired MBSCC and named the
resulting entity FICC.\13\ At the time of the merger, both GSCC and
MBSCC were operating under temporary registrations with the Commission,
and FICC has operated under a temporary registration since that time.
The temporary registrations granted to MBSCC and GSCC exempted them
from certain requirements imposed by Section 17A of the Act.\14\
Specifically, both MBSCC and GSCC were exempted from compliance with
the Act's fair representation requirement,\15\ and GSCC was further
exempted from the Act's participation requirements.\16\ The exemptions
granted to MBSCC and GSCC have since been removed because the
Commission determined that both clearing agencies satisfied the
statutory requirements from which the entities were previously
exempted.\17\ Thus, FICC is now subject to all requirements applicable
to registered clearing agencies.
---------------------------------------------------------------------------

    \6\ Securities Exchange Act Release No. 23929 (December 23,
1986), 52 FR 373-01 (January 5, 1987) (File No. 600-22).
    \7\ Securities Exchange Act Release No. 24046 (February 2,
1987), 52 FR 4218-01 (February 10, 1987) (File No. 600-22).
    \8\ Securities Exchange Act Release No. 25957 (August 2, 1988),
53 FR 29537-01 (August 2, 1988) (File No. 600-19); Securities
Exchange Act Release No. 27079 (July 31, 1989), 54 FR 32412-01
(August 7, 1989) (File No. 600-22); Securities Exchange Act Release
No. 28492 (September 28, 1990), 55 FR 41148-03 (October 9, 1990)
(File No. 600-19); Securities Exchange Act Release No. 29751
(September 27, 1991), 56 FR 50602-01 (October 7, 1991) (File Nos.
600-19 and 600-22); Securities Exchange Act Release No. 31750
(January 21, 1993), 58 FR 6424-02 (January 28, 1993) (File Nos. 600-
19 and 600-22) (noting that, ``[d]ue to an inadvertent
administrative error by MBSCC,'' MBSCC failed to request an
extension of its temporary registration prior to the expiration of
its last extension on September 30, 1992); Securities Exchange Act
Release No. 33348 (December 15, 1993), 58 FR 68183-01 (December 23,
1993) (File Nos. 600-19 and 600-22); Securities Exchange Act Release
No. 35132 (December 21, 1994), 59 FR 67743-01 (December 30, 1994)
(File Nos. 600-19 and 600-22); Securities Exchange Act Release No.
37372 (June 26, 1996), 61 FR 35281-02 (July 5, 1996) (File No. 600-
22); Securities Exchange Act Release No. 38784 (June 27, 1997), 62
FR 36587-01 (July 8, 1997) (File No. 600-22); Securities Exchange
Act Release No. 39776 (March 20, 1998), 63 FR 14740-02 (March 26,
1998) (File No. 600-22); Securities Exchange Act Release No. 42568
(March 23, 2000), 65 FR 16980-01 (March 30, 2000) (File No. 600-22);
Securities Exchange Act Release No. 44089 (March 21, 2001), 66 FR
16961-02 (March 28, 2001) (File No. 600-22); Securities Exchange Act
Release No. 44831 (September 21, 2001), 66 FR 49728-01 (September
28, 2001) (File No. 600-22); Securities Exchange Act Release No.
45607 (March 20, 2002), 67 FR 14755-01 (March 27, 2002) (File No.
600-22); Securities Exchange Act Release No. 46136 (June 27, 2002),
67 FR 44655-01 (July 3, 2002) (File No. 600-22).
    \9\ Securities Exchange Act Release No. 25129 (November 16,
1987), 52 FR 44659-01 (November 20, 1987) (File No. 600-23).
    \10\ Securities Exchange Act Release No. 25740 (May 24, 1988),
53 FR 19839 (May 24, 1987) (File No. 600-23).
    \11\ Securities Exchange Act Release No. 29236 (May 24, 1991),
56 FR 24852 (May 31, 1991) (File No. 600-23); Securities Exchange
Act Release No. 32385 (June 3, 1993), 58 FR 32405 (June 9, 1993)
(File No. 600-23); Securities Exchange Act Release No. 35787 (May
31, 1995), 60 FR 30324 (June 8, 1995) (File No. 600-23); Securities
Exchange Act Release No. 36508 (November 27, 1995), 60 FR 61719
(December 1, 1995) (File No. 600-23); Securities Exchange Act
Release No. 37983 (November 25, 1996), 61 FR 64183 (December 3,
1996) (File No. 600-23); Securities Exchange Act Release No. 38698
(May 30, 1997), 62 FR 30911 (June 5, 1997) (File No. 600-23);
Securities Exchange Act Release No. 39696 (February 24, 1998), 63 FR
10253 (March 2, 1998) (File No. 600-23); Securities Exchange Act
Release No. 41104 (February 24, 1999), 64 FR 10510 (March 4, 1999)
(File No. 600-23); Securities Exchange Act Release No. 41805 (August
27, 1999), 64 FR 48682 (September 7, 1999) (File No. 600-23);
Securities Exchange Act Release No. 42335 (January 12, 2000), 65 FR
3509 (January 21, 2000) (File No. 600-23); Securities Exchange Act
Release No. 43089 (July 28, 2000), 65 FR 48032 (August 4, 2000)
(File No. 600-23); Securities Exchange Act Release No. 43900
(January 29, 2001), 66 FR 8988 (February 5, 2001) (File No. 600-23);
Securities Exchange Act Release No. 44553 (July 13, 2001), 66 FR
37714 (July 19, 2001) (File No. 600-23); Securities Exchange Act
Release No. 45164 (December 18, 2001), 66 FR 66957 (December 27,
2001) (File No. 600-23); and Securities Exchange Act Release No.
46135 (June 27, 2002), 67 FR 44655 (July 3, 2002) (File No. 600-23).
    \12\ See Letter from Jeffrey F. Ingber, Managing Director,
General Counsel and Secretary, FICC (Nov. 15, 2002).
    \13\ Securities Exchange Act Release No. 47015 (December 17,
2002), 67 FR 78531 (December 24, 2002) (File Nos. SR-GSCC-2002-07
and SR-MBSCC-2002-01).
    \14\ Pursuant to Rule 17Ab2-1(c)(1), the Commission may grant
registration to a clearing agency while exempting it from one or
more of the requirements of paragraphs (A) through (I) of section
17A(b)(3) of the Act. See 17 C.F.R. 240.17Ab2-1(c)(1).
    \15\ Securities Exchange Act Release No. 24046 (February 2,
1987), 52 FR 4218-01 (February 10, 1987) (File No. 600-22);
Securities Exchange Act Release No. 25740 (May 24, 1988), 53 FR
19839-01 (May 31, 1988) (File No. 600-23).
    \16\ Securities Exchange Act Release No. 25740 (May 24, 1988),
53 FR 19839-01 (May 31, 1988) (File No. 600-23).
    \17\ Securities Exchange Act Release No. 26729 (April 14, 1989),
54 FR 16438-G-01 (April 24, 1989) (SR-MBSS-89-2) (lifting MBSCC's
exemption from the Act's fair representation requirements);
Securities Exchange Act Release No. 36508 (November 27, 1995), 60 FR
61719-02 (December 1, 1995) (File No. 600-23) (lifting GSCC's
exemption from the Act's participation requirements); Securities
Exchange Act Release No. 39372 (November 28, 1997), 62 FR 64415
(December 5, 1997) (SR-GSCC-97-01) (lifting GSCC's exemption from
the Act's fair representation requirements).
---------------------------------------------------------------------------

    Following GSCC's acquisition of MBSCC, the Commission extended
FICC's temporary registration on several occasions.\18\ The Commission
most recently extended FICC's temporary registration on June 20,
2011.\19\ At that time, the Commission explained that it would consider
whether to grant FICC permanent registration after the Commission acted
upon FICC's proposal to introduce central counterparty and guarantee
settlement services to FICC's Mortgage-Backed Securities Division. The
Commission approved FICC's request to allow its Mortgage-Backed
Securities Division to act as a central counterparty and settlement
guarantor on March 9, 2012.\20\ FICC's temporary registration expires
on June 30, 2013.\21\
---------------------------------------------------------------------------

    \18\ Securities Exchange Act Release No. 48116 (July 1, 2003),
68 FR 41031 (July 9, 2003) (File No. 600-23); Securities Exchange
Act Release No. 49940 (June 29, 2004), 69 FR 40695 (July 5, 2004)
(File No. 600-23); Securities Exchange Act Release No. 51911 (June
23, 2005), 70 FR 37878 (June 30, 2005) (File No. 600-23); Securities
Exchange Act Release No. 54056 (June 28, 2006), 71 FR 38193 (July 5,
2006) (File No. 600-23); Securities Exchange Act Release No. 55920
(June 18, 2007), 72 FR 35270 (June 27, 2007) (File No. 600-23); and
Securities Exchange Act Release No. 57949 (June 11, 2008), 73 FR
34808 (June 18, 2008) (File No. 600-23).
    \19\ Securities Exchange Act Release No. 64707 (June 20, 2011),
76 FR 37165 (June 24, 2011) (File No. 600-23).
    \20\ Securities Exchange Act Release No. 66550 (March 9, 2012),
77 FR 15155 (March 14, 2012) (File No. 600-23).
    \21\ Securities Exchange Act Release No. 64707 (June 20, 2011),
76 FR 37165 (June 24, 2011) (File No. 600-23).
---------------------------------------------------------------------------

III. Overview of FICC

    FICC is a wholly owned subsidiary of the Depository Trust &
Clearing Corporation (``DTCC''), and is generally administered as an
industry-owned utility on an at-cost basis. FICC is comprised of two
separate divisions, the Government Securities Division (``FICC/GSD'')
and the Mortgage-Backed Securities Division (``FICC/MBSD''). Each
Division has its own set of rules and membership.
    FICC/GSD is the sole clearing agency in the United States acting as
a central counterparty for cash-settled U.S.

Government and agency securities. FICC/GSD provides clearing, netting,
settlement, risk management, central counterparty services and a
guarantee of trade completion for the following securities: (i) U.S.
Treasury bills, notes, bonds, Treasury inflation-protected securities
(TIPS), and Separate Trading of Registered Interest and Principal
Securities (STRIPS), and (ii) Federal agency notes, bonds and zero-
coupon securities that are book-entry, Fedwire eligible and non-
mortgage backed. FICC/GSD accepts buy-sell transactions, repurchase and
reverse repurchase agreement transactions (repos), and Treasury auction
purchases in several types of U.S. Government securities.
    FICC/MBSD is the only centralized clearing facility in the non-
private label mortgage-backed securities market. FICC/MBSD provides
clearing, netting, settlement, risk management, pool notification,
central counterparty services and a guarantee of trade completion for
pass-through mortgage-backed securities issued by the Government
National Mortgage Association (``Ginnie Mae''), the Federal Home Loan
Mortgage Corporation (``Freddie Mac'') and the Federal National
Mortgage Association (``Fannie Mae''). FICC/MBSD also processes options
trades for ``to-be-announced'' transactions.
    Additional information concerning FICC and its operations may be
found in the schedule and non-confidential exhibits appended to FICC's
amended Form CA-1.\22\ Schedule A to FICC's amended Form CA-1 includes
a description of the risk management procedures utilized by FICC/GSD
and FICC/MBSD. Exhibits A and B provide a list of FICC's Board of
Directors and its officers and senior managers, respectively. Exhibit C
includes both a narrative and graphical depiction of FICC's
organizational structure, and Exhibit E includes copies of the current
rulebooks for both FICC/GSD and FICC/MBSD, along with copies of FICC's
governing documents. Finally, Exhibit J provides a description of
FICC's services and functions.
---------------------------------------------------------------------------

    \22\ FICC's amended Form CA-1, including the exhibits,
attachments and the schedule referenced above, is available online
at www.sec.gov/rules/other.shtml, as well as at the Commission's
Public Reference Room.
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning FICC's amended Form CA-1, including whether FICC
has satisfied the Act's requirements for registration. Comments may be
submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml) or
     Send an email to<EMAIL_ADDRESS>Please include
File Number 600-23 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number 600-23. This file number
should be included on the subject line if email is used. To help the
Commission process and review your comments more efficiently, please
use only one method of submission. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the amended Form CA-1, all subsequent
amendments, all written statements with respect to FICC's amended Form
CA-1 that are filed with the Commission, and all written communications
relating to the amended Form CA-1 between the Commission and any
person, other than those that may be withheld from the public in
accordance with the provisions of 5 U.S.C. 552, will be available for
Web site viewing and printing in the Commission's Public Reference
Room, 100 F Street NE., Washington, DC 20549, on official business days
between the hours of 10:00 a.m. and 3:00 p.m.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number 600-23 and should
be submitted on or before June 3, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-08924 Filed 4-16-13; 8:45 am]
BILLING CODE 8011-01-P